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Evaluation of Spin Bias in Systematic Reviews and Meta-analyses of Rotator Cuff Repair With Platelet-Rich Plasma
Moulton, S. G., Hartwell, M. J., Feeley, B. T.
The American journal of sports medicine. 2024;:3635465231213039
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Editor's Choice
Abstract
BACKGROUND The use of platelet-rich plasma (PRP) in orthopaedics continues to increase. One common use of PRP is as an adjunct in rotator cuff repair surgery. Multiple systematic reviews and meta-analyses have summarized the data on PRP use in rotator cuff repair surgery. However, systematic reviews and meta-analyses are subject to spin bias, where authors' interpretations of results influence readers' interpretations. PURPOSE To evaluate spin in the abstracts of systematic reviews and meta-analyses of PRP with rotator cuff repair surgery. STUDY DESIGN Systematic review; Level of evidence, 3. METHODS A PubMed and Embase search was conducted using the terms rotator cuff repair and PRP and systematic review or meta-analysis. After review of 74 initial studies, 25 studies met the inclusion criteria. Study characteristics were documented, and each study was evaluated for the 15 most common forms of spin and using the AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews, Version 2) rating system. Correlations between spin types and study characteristics were evaluated using binary logistic regression for continuous independent variables and a chi-square test or Fisher exact test for categorical variables. RESULTS At least 1 form of spin was found in 56% (14/25) of the included studies. In regard to the 3 different categories of spin, a form of misleading interpretation was found in 56% (14/25) of the studies. A form of misleading reporting was found in 48% (12/25) of the studies. A form of inappropriate extrapolation was found in 16% (4/25) of the studies. A significant association was found between misleading interpretation and publication year (odds ratio [OR], 1.41 per year increase in publication; 95% CI, 1.04-1.92; P = .029) and misleading reporting and publication year (OR, 1.41 per year increase in publication; 95% CI, 1.02-1.95; P = .037). An association was found between inappropriate extrapolation and journal impact factor (OR, 0.21 per unit increase in impact factor; 95% CI, 0.044-0.99; P = .048). CONCLUSION A significant amount of spin was found in the abstracts of systematic reviews and meta-analyses of PRP use in rotator cuff repair surgery. Given the increasing use of PRP by clinicians and interest among patients, spin found in these studies may have a significant effect on clinical practice.
PICO Summary
Population
Patients undergoing arthroscopic rotator cuff repair surgery with platelet-rich plasma (PRP) (25 studies).
Intervention
Systematic review to evaluate the presence of spin bias in the abstracts of systematic reviews and meta-analyses of PRP with rotator cuff repair surgery.
Comparison
Outcome
Each included study was evaluated for the 15 most common forms of spin. Correlations between spin types and study characteristics were evaluated. At least 1 form of spin bias was found in 56% (14/25) of the included studies. In regard to the 3 different categories of spin, a form of misleading interpretation was found in 56% (14/25) of the studies. A form of misleading reporting was found in 48% (12/25) of the studies. A form of inappropriate extrapolation was found in 16% (4/25) of the studies. A significant association was found between misleading interpretation and publication year (odds ratio (OR) 1.41 per year increase in publication; 95% CI [1.04, 1.92]) and misleading reporting and publication year (OR 1.41 per year increase in publication; 95% CI [1.02, 1.95]). An association was found between inappropriate extrapolation and journal impact factor (OR 0.21 per unit increase in impact factor; 95% CI [0.044, 0.99]).
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[Efficacy and safety of multiple-dose intravenous tranexamic acid for reducing blood loss in complex tibial plateau fractures: A prospective randomized controlled trial]
Bao, W., Zhou, J., Wang, Y., Wang, J., Chu, M.
Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery. 2023;37(9):1055-1061
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Editor's Choice
Abstract
OBJECTIVE To investigate the efficacy and safety of multiple-dose intravenous tranexamic acid (TXA) for reducing blood loss in complex tibial plateau fractures with open reduction internal fixation by a prospective randomized controlled trial. METHODS A study was conducted on patients with Schatzker type Ⅳ-Ⅵ tibial plateau fractures admitted between August 2020 and December 2022. Among them, 88 patients met the selection criteria and were included in the study. They were randomly allocated into 3 groups, the control group (28 cases), single-dose TXA group (31 cases), and multiple-dose TXA group (29 cases), using a random number table method. There was no significant difference ( P>0.05) in terms of age, gender, body mass index, the Schatzker type and side of fracture, laboratory examinations [hemoglobin (Hb), activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fib), international normalized ratio (INR), D-dimer, and interleukin 6 (IL-6)], and preoperative blood volume. The control group received intravenous infusion of 100 mL saline at 15 minutes before operation and 3, 6, and 24 hours after the first administration. The single-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at 15 minutes before operation, followed by an equal amount of saline at each time point after the first administration. The multiple-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at each time point. The relevant indicators were recorded and compared between groups to evaluate the effectiveness and safety of TXA, including hospital stays, operation time, occurrence of infection; the occurrence of lower extremity deep vein thrombosis, intermuscular vein thrombosis, and pulmonary embolism at 1 week after operation; the lowest postoperative Hb value and Hb reduction rate, the difference (change value) between pre- and post-operative APTT, PT, Fib, and INR; D-dimer and IL-6 at 24 and 72 hours after operation; total blood loss, intraoperative blood loss, hidden blood loss, drainage flow during 48 hours after operation, and postoperative blood transfusion. RESULTS ① TXA efficacy evaluation: the lowest Hb value in the control group was significantly lower than that in the other two groups ( P<0.05), and there was no significant difference between the single- and multiple-dose TXA groups ( P>0.05). The Hb reduction rate, total blood loss, intraoperative blood loss, drainage flow during 48 hours after operation, and hidden blood loss showed a gradual decrease trend in the control group, single-dose TXA group, and multiple-dose TXA group. And differences were significant ( P<0.05) in the Hb reduction rate and drainage flow during 48 hours after operation between groups, and the total blood loss and hidden blood loss between control group and other two groups. ② TXA safety evaluation: no lower extremity deep vein thrombosis or pulmonary embolism occurred in the three groups after operation, but 3, 4, and 2 cases of intermuscular vein thrombosis occurred in the control group, single-dose TXA group, and multiple-dose TXA group, respectively, and the differences in the incidences between groups were not significant ( P>0.05). There was no significant difference in the operation time between groups ( P>0.05). But the length of hospital stay was significantly longer in the control group than in the other groups ( P<0.05); there was no significant difference between the single- and multiple-dose TXA groups ( P>0.05). ③ Effect of TXA on blood coagulation and inflammatory response: the incisions of the 3 groups healed by first intention, and no infections occurred. The differences in the changes of APTT, PT, Fib, and INR between groups were not significant ( P>0.05). The D-dimer and IL-6 in the three groups showed a trend of first increasing and then decreasing over time, and there was a significant difference between different time points in the three groups ( P<0.05). At 24 and 72 hours after operation, there was no significant difference in D-dimer between groups ( P>0.05), while there was a significant difference in IL-6 between groups ( P<0.05). CONCLUSION Multiple intravenous applications of TXA can reduce perioperative blood loss and shorten hospital stays in patients undergoing open reduction and internal fixation of complex tibial plateau fractures, provide additional fibrinolysis control and ameliorate postoperative inflammatory response.
PICO Summary
Population
Patients with Schatzker type IV – VI tibial plateau fractures (n= 88).
Intervention
Single dose of tranexamic acid (TXA) intravenous infusion, (n= 31).
Comparison
Multiple dose of intravenous TXA (n= 29); normal saline (control group), (n= 28).
Outcome
TXA efficacy evaluation: The lowest haemoglobin (Hb) value in the control group was significantly lower than that in the other two groups, and there was no significant difference between the single and multiple dose TXA groups. The Hb reduction rate, total blood loss, intraoperative blood loss, drainage flow during 48 hours after operation, and hidden blood loss showed a gradual decrease trend in the control group, single-dose TXA group, and multiple-dose TXA group. And differences were significant in the Hb reduction rate and drainage flow during 48 hours after operation between groups, and the total blood loss and hidden blood loss between control group and other two groups. TXA safety evaluation: No lower extremity deep vein thrombosis or pulmonary embolism occurred in the three groups after operation. There was no significant difference in the operation time between groups. But the length of hospital stay was significantly longer in the control group than in the other groups. Effect of TXA on blood coagulation and inflammatory response: The incisions of the 3 groups healed by first intention, and no infections occurred.
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Cryotherapy following total knee replacement
Aggarwal, A., Adie, S., Harris, I. A., Naylor, J.
The Cochrane database of systematic reviews. 2023;9(9):Cd007911
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Abstract
BACKGROUND Total knee replacement (TKR) is a common intervention for people with end-stage symptomatic knee osteoarthritis, resulting in significant improvements in pain, function and quality of life within three to six months. It is, however, acutely associated with pain, local oedema and blood loss. Post-operative management may include cryotherapy. This is the application of low temperatures to the skin surrounding the surgical site, through ice or cooled water, often delivered using specialised devices. This is an update of a review published in 2012. OBJECTIVES To evaluate the effect of cryotherapy in the acute phase after TKR (within 48 hours after surgery) on blood loss, pain, transfusion rate, range of motion, knee function, adverse events and withdrawals due to adverse events. SEARCH METHODS We searched CENTRAL, MEDLINE, Embase, six other databases and two trials registers, as well as reference lists, related links and conference proceedings on 27 May 2022. SELECTION CRITERIA We included randomised controlled trials or controlled clinical trials comparing cryotherapy with or without other treatments (such as compression, regional nerve block or continuous passive motion) to no treatment, or the other treatment alone, following TKR for osteoarthritis. DATA COLLECTION AND ANALYSIS Two review authors independently selected studies for inclusion, extracted data and assessed risk of bias and certainty of evidence using GRADE. We discussed any disagreements and consulted another review author to resolve them, if required. Major outcomes were blood loss, pain, transfusion rate, knee range of motion, knee function, total adverse events and withdrawals from adverse events. Minor outcomes were analgesia use, knee swelling, length of stay, quality of life, activity level and participant-reported global assessment of success. MAIN RESULTS We included 22 trials (20 randomised trials and two controlled clinical trials), with 1839 total participants. The mean ages reflected the TKR population, ranging from 64 to 74 years. Cryotherapy with compression was compared to no treatment in four studies, and to compression alone in nine studies. Cryotherapy without compression was compared to no treatment in eight studies. One study compared cryotherapy without compression to control with compression alone. We combined all control interventions in the primary analysis. Certainty of evidence was low for blood loss (downgraded for bias and inconsistency), pain (downgraded twice for bias) and range of motion (downgraded for bias and indirectness). It was very low for transfusion rate (downgraded for bias, inconsistency and imprecision), function (downgraded twice for bias and once for inconsistency), total adverse events (downgraded for bias, indirectness and imprecision) and withdrawals from adverse events (downgraded for bias, indirectness and imprecision). The nature of cryotherapy made blinding difficult and most studies had a high risk of performance and detection bias. Low-certainty evidence from 12 trials (956 participants) shows that cryotherapy may reduce blood loss at one to 13 days after surgery. Blood loss was 825 mL with no cryotherapy and 561 mL with cryotherapy: mean difference (MD) 264 mL less (95% confidence interval (CI) 7 mL less to 516 mL less). Low-certainty evidence from six trials (530 participants) shows that cryotherapy may slightly improve pain at 48 hours on a 0- to 10-point visual analogue scale (lower scores indicate less pain). Pain was 4.8 points with no cryotherapy and 3.16 points with cryotherapy: MD 1.6 points lower (95% CI 2.3 lower to 1.0 lower). We are uncertain whether cryotherapy improves transfusion rate at zero to 13 days after surgery. The transfusion rate was 37% with no cryotherapy and 79% with cryotherapy (risk ratio (RR) 2.13, 95% CI 0.04 to 109.63; 2 trials, 91 participants; very low-certainty evidence). Low-certainty evidence from three trials (174 participants) indicates cryotherapy may improve range of motion at discharge: it was 62.9 degrees with no cryotherapy and 71.2 degrees with cryotherapy: MD 8.3 degrees greater (95% CI 3.6 degrees more to 13.1 degrees more). We are uncertain whether cryotherapy improves function two weeks after surgery. Function was 75.4 points on the 0- to 100-point Dutch Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale (lower score indicates worse function) in the control group and 88.6 points with cryotherapy (MD 13.2 points better, 95% CI 0.5 worse to 27.1 improved; 4 trials, 296 participants; very low-certainty evidence). We are uncertain whether cryotherapy reduces total adverse events: the risk ratio was 1.30 (95% CI 0.53 to 3.20; 16 trials, 1199 participants; very low-certainty evidence). Adverse events included discomfort, local skin reactions, superficial infections, cold-induced injuries and thrombolytic events. We are uncertain whether cryotherapy reduces withdrawals from adverse events (RR 2.71, 95% CI 0.42 to 17.38; 19 trials, 1347 participants; very low-certainty evidence). No significant benefit was found for secondary outcomes of analgesia use, length of stay, activity level or quality of life. Evidence from seven studies (403 participants) showed improved mid-patella swelling between two and six days after surgery (MD 7.32 mm less, 95% CI 11.79 to 2.84 lower), though not at six weeks and three months after surgery. The included studies did not assess participant-reported global assessment of success. AUTHORS' CONCLUSIONS The certainty of evidence was low for blood loss, pain and range of motion, and very low for transfusion rate, function, total adverse events and withdrawals from adverse events. We are uncertain whether cryotherapy improves transfusion rate, function, total adverse events or withdrawals from adverse events. We downgraded evidence for bias, indirectness, imprecision and inconsistency. Hence, the potential benefits of cryotherapy on blood loss, pain and range of motion may be too small to justify its use. More well-designed randomised controlled trials focusing especially on clinically meaningful outcomes, such as blood transfusion, and patient-reported outcomes, such as knee function, quality of life, activity level and participant-reported global assessment of success, are required.
PICO Summary
Population
People undergoing total knee replacement (22 trials, n= 1,839).
Intervention
Cryotherapy alone or with another therapy aiming to reduce pain and swelling.
Comparison
No treatment; other treatments aiming to reduce pain and swelling (e.g., compression bandaging, regional nerve block or continuous passive motion).
Outcome
Blood loss was 264 mL less with cryotherapy at up to 13 days after surgery. 11% more people had a blood transfusion with cryotherapy, or 11 more out of 100, at up to 13 days after surgery. Pain was better by 1.6 points on a 0‐ to 10‐point scale with cryotherapy at 2 days after surgery. For knee range of motion: flexion was 8.3 degrees greater with cryotherapy when people left hospital. Knee function was 13.2 points better on a 0- to 100-point scale with cryotherapy at 2 weeks after surgery. For total adverse events: 2.7 out of 100 people reported adverse events with cryotherapy, and 2.1 out of 100 people reported adverse events without cryotherapy. The certainty of evidence was low for blood loss, pain and range of motion, and very low for transfusion rate, function, total adverse events and withdrawals from adverse events. The authors are uncertain whether cryotherapy improves transfusion rate, function, total adverse events or withdrawals from adverse events. The authors downgraded evidence for bias, indirectness, imprecision and inconsistency.
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Ferric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 × 2 factorial, randomised, double-blind, controlled trial
Lasocki, S., Capdevila, X., Vielle, B., Bijok, B., Lahlou-Casulli, M., Collange, V., Grillot, N., Danguy des Deserts, M., Duchalais, A., Delannoy, B., et al
The Lancet. Haematology. 2023
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Editor's Choice
Abstract
BACKGROUND Anaemia and blood transfusion are associated with poor outcomes after hip fracture. We evaluated the efficacy of intravenous iron and tranexamic acid in reducing blood transfusions after hip fracture surgery. METHODS In this double-blind, randomised, 2 × 2 factorial trial, we recruited adults hospitalised for hip fractures in 12 medical centres in France who had preoperative haemoglobin concentrations between 9·5 and 13·0 g/dL. We randomly allocated participants (1:1:1:1), via a secure web-based service, to ferric derisomaltose (20 mg/kg intravenously) and tranexamic acid (1 g bolus followed by 1 g over 8 h intravenously at inclusion and 3 g topically during surgery), iron plus placebo (normal saline), tranexamic acid plus placebo, or double placebo. Unmasked nurses administered study drugs; participants and other clinical and research staff remained masked to treatment allocation. The primary outcome was the percentage of patients transfused during hospitalisation (or by day 30). The primary analysis included all randomised patients. This study is registered on ClinicalTrials.gov (NCT02972294) and is closed to new participants. FINDINGS Of 413 patients (51-104 years old, median [IQR] 86 [78-91], 312 [76%] women, 101 [24%] men), 104 received iron plus tranexamic acid, 103 iron plus placebo, 103 tranexamic acid plus placebo, and 103 double placebo between March 31, 2017 and June 18, 2021 (study stopped early for efficacy after the planned interim analysis done on the first 390 patients included on May 25, 2021). Data for the primary outcome were available for all participants. Among patients on double placebo, 31 (30%) were transfused versus 16 (15%) on both drugs (relative risk 0·51 [98·3% CI 0·27-0·97]; p=0·012). 27 (26%) participants on iron (0·81 [0·50-1·29]; p=0·28) and 28 (27%) on tranexamic acid (0·85 [0·54-1·33]; p=0·39) were transfused. 487 adverse events were reported with similar event rates among the groups; among prespecified safety endpoints, severe postoperative anaemia (haemoglobin <8 g/dL) was more frequent in the double placebo group. Main common adverse event were sepsis, pneumonia, and urinary infection, with similar rates among all groups. INTERPRETATION In patients hospitalised for hip fracture surgery with a haemoglobin concentration 9·5-13·0 g/dL, preoperative infusion of ferric derisomaltose plus tranexamic acid reduced the risk of blood transfusion by 50%. Our results suggest that combining treatments from two different pillars improves patient blood-management programmes. Either treatment alone did not reduce transfusion rates, but we might not have had the power to detect it. FUNDING French Ministry of Health, HiFIT trial.
PICO Summary
Population
Adults hospitalised for hip fractures in 12 medical centres in France, enrolled in the Hip Fracture Iron and Tranexamic acid (HiFIT) trial (n= 413).
Intervention
Iron plus tranexamic acid (n= 104).
Comparison
Iron plus placebo (n= 103). Tranexamic acid plus placebo (n= 103). Double placebo (n= 103).
Outcome
Among patients on double placebo, 31 (30%) were transfused vs. 16 (15%) on both drugs (relative risk 0.51; 98.3% CI [0.27, 0.97]); 27 (26%) participants on iron (relative risk 0.81; 98.3% CI [0.50, 1.29]) and 28 (27%) on tranexamic acid (relative risk 0.85; 98.3% CI [0.54, 1.33]) were transfused. 487 adverse events were reported with similar event rates among the groups; among prespecified safety endpoints, severe postoperative anaemia (haemoglobin <8 g/dL) was more frequent in the double placebo group. Main common adverse events were sepsis, pneumonia, and urinary infection, with similar rates among all groups.
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Tourniquet use benefits to reduce intraoperative blood loss in patients receiving total knee arthroplasty for osteoarthritis: An updated meta-analysis with trial sequential analysis
Xu, X., Wang, C., Song, Q., Mou, Z., Dong, Y.
Journal of orthopaedic surgery (Hong Kong). 2023;31(2):10225536231191607
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Editor's Choice
Abstract
PURPOSE The efficacy and safety of tourniquets use during total knee arthroplasty (TKA) in patients with osteoarthritis remain debated. This updated systematic review and meta-analysis aimed to further evaluate the role of tourniquets use in patients undergoing TKA for knee osteoarthritis by introducing trial sequential analysis. METHODS PubMed, Embase, and the Cochrane Library were searched. We used the Cochrane risk of bias tool for quality assessment. Statistical heterogeneity across studies was evaluated using Cochran's Q and I(2) statistic. Meta-analysis was performed using Stata/SE 14.0, and trail sequential analysis was performed using TSA software version 0.9.5.10 Beta. In addition, qualitative summary was also used to describe results. RESULTS 15 randomized controlled trials (RCTs) involving 1202 patients were included in the meta-analysis. The pooled results showed that tourniquet use during TKA significantly reduced intraoperative blood loss (mean difference (MD)= -123.84, 95% confidence interval (CI): -163.37 to -84.32, p < .001)and shortened operation time (MD = -4.71, 95% CI: -7.6 to -1.82, p = .001), but there were no significant differences in postoperative blood loss, calculated blood loss, total blood loss, transfusion rate (p = .939), and deep venous thrombosis (DVT) rate between the tourniquet and no-tourniquet groups. TSA confirmed that the result of operation time was false positive, but the results of other outcomes were conclusive. The results of qualitative summary showed conflicting findings in terms of pain, range of motion (RoM) and swelling ratio between the two groups. CONCLUSIONS Tourniquet use in patients receiving TKA for osteoarthritis benefits to reduce intraoperative blood loss but has no effect on postoperative blood loss, calculated blood loss, total blood loss, operation time, transfusion rate, and DVT rate. In addition, it remains unclear the difference between the tourniquet and non-tourniquet groups in terms of pain, RoM and swelling ratio.
PICO Summary
Population
Patients undergoing total knee arthroplasty (TKA) for osteoarthritis (15 randomised controlled trials, n= 1,202).
Intervention
Tourniquet.
Comparison
Non-use of tourniquet.
Outcome
The pooled results showed that tourniquet use during TKA significantly reduced intraoperative blood loss (mean difference (MD)= -123.84; 95% confidence interval (CI) [-163.37, -84.32]) and shortened operation time (MD= -4.71; 95% CI [-7.6 to, -1.82]), but there were no significant differences in postoperative blood loss, calculated blood loss, total blood loss, transfusion rate, and deep venous thrombosis rate between the tourniquet and no-tourniquet groups. Trial sequential analyses confirmed that the result of operation time was false positive, but the results of other outcomes were conclusive. The results of qualitative summary showed conflicting findings in terms of pain, range of motion and swelling ratio between the two groups.
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IRON NOF trial: IV iron for anaemic patients with femoral fracture
O'Loughlin, E., Chih, H., Sivalingam, P., Symons, J., Godsall, G., MacLean, B., Richards, T.
BJA open. 2023;7:100222
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Editor's Choice
Abstract
BACKGROUND Preoperative anaemia is associated with increased use of blood transfusions, a greater risk of postoperative complications, and patient morbidity. The IRON NOF trial aimed to investigate whether the administration of i.v. iron in anaemic patients during hip fracture surgery reduced the need for blood transfusion and improved patient outcomes. METHODS This phase III double-blind, randomised, placebo-controlled trial included patients >60 yr old with preoperative anaemia undergoing surgery for femoral neck or subtrochanteric fracture across seven Australian Hospitals. Patients were randomly allocated on a 1:1 basis to receive either i.v. iron carboxymaltose 1000 mg or placebo (saline) at operation. The primary endpoint was blood transfusion use, with secondary endpoints of haemoglobin concentration at 6 weeks, length of hospital stay, rehabilitation duration to discharge, and 6-month mortality. Subgroup analysis compared outcomes in patients <80 yr old and patients >80 yr old. All analyses were performed by intention-to-treat. This trial was terminated early because of jurisdictional changes of more restrictive transfusion practices and changes in consent requirements. RESULTS Participants (n=143) were recruited between February 2013 and May 2017. There was no difference observed in the incidence of blood transfusion between the treatment group (18/70) (26%) compared with the placebo group (27/73) (37%) (odds ratio for transfusion if receiving placebo: 1.70; 95% confidence interval [CI] 0.83-3.47; P=0.15) and there was no overall difference in the median number of blood units transfused between groups (odds ratio 1.52; 95% CI 0.77-3.00; P=0.22). Patients receiving i.v. iron had a higher haemoglobin 6 weeks after intervention compared with the placebo group (Hb 116 g L(-1)vs 108 g L(-1); P=0.01). No difference was observed in length of hospital stay, rehabilitation duration to discharge, or 6-month mortality. However, in younger patients without major bleeding, the use of placebo compared with i.v. iron was associated with an increased number of units of blood transfused (placebo transfusion incidence rate ratio 3.88; 95% CI 1.16-13.0; P=0.03). CONCLUSIONS In anaemic patients undergoing surgery for hip fracture, i.v. iron did not reduce the overall proportion of patients receiving blood transfusion. The use of i.v. iron may reduce the amount of blood transfused in younger patients. The use of i.v. iron is associated with increased haemoglobin concentrations 6 weeks after the operation. CLINICAL TRIAL REGISTRATION ACTRN12612000448842.
PICO Summary
Population
Patients with preoperative anaemia undergoing surgery for femoral neck or subtrochanteric fracture, enrolled in the IRON NOF trial across seven Australian hospitals (n= 143).
Intervention
Intravenous iron carboxymaltose (n= 70).
Comparison
Placebo (saline), (n= 73).
Outcome
All analyses were performed by intention-to-treat. The trial was terminated early because of jurisdictional changes of more restrictive transfusion practices and changes in consent requirements. There was no difference observed in the incidence of blood transfusion between the treatment group 18/70 (26%) compared with the placebo group 27/73 (37%), (odds ratio for transfusion if receiving placebo: 1.70; 95% confidence interval (CI) [0.83, 3.47]) and there was no overall difference in the median number of blood units transfused between groups (odds ratio 1.52; 95% CI [0.77, 3.00]). Patients receiving intravenous iron had a higher haemoglobin 6 weeks after intervention compared with the placebo group (Hb 116 g L(-1) vs. 108 g L(-1)). No difference was observed in length of hospital stay, rehabilitation duration to discharge, or 6-month mortality. In younger patients without major bleeding, the use of placebo compared with intravenous iron was associated with an increased number of units of blood transfused (placebo transfusion incidence rate ratio 3.88; 95% CI [1.16, 13.0]).
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Perioperative blood loss reduction using a sterile exsanguination tourniquet for orthopedic femoral-related surgeries in children: a randomized controlled study
Rattanathanya, T., Adulkasem, N., Wongcharoenwatana, J., Ariyawatkul, T., Chotigavanichaya, C., Eamsobhana, P.
Journal of orthopaedic surgery and research. 2023;18(1):580
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Editor's Choice
Abstract
OBJECTIVES The sterile exsanguination tourniquet (SET) could be an alternative for providing bloodless surgeries in orthopedic femoral-related surgeries in pediatric patients where the standard pneumatic tourniquet would not be feasible. This randomized-controlled study aimed to evaluate the efficacy of SET in decreasing total perioperative blood loss and blood transfusion. METHODS We conducted an unplanned interim analysis of data from a randomized-controlled trial. At the time of the analysis, 31 pediatric patients had been randomly assigned to undergo surgery with the SET application (the SET group, 15 patients) and without the SET application (the control group, 16 patients). An intention-to-treat analysis was performed to evaluate the total perioperative blood loss, postoperative blood transfusion, estimated intraoperative blood loss, total drainage volume, postoperative hemoglobin level, and operative time according to the significance level adjusted for multiplicity (p < 0.029). RESULTS There was a borderline statistically significant lower body weight-adjusted TBL in the SET group (SET = 14.1 (7.7, 16.9) ml/kg vs. control 18.3 (14.8, 37.2) ml/kg, p-value = 0.027). The body weight-adjusted transfusion volume was statistically significantly greater in the control group (SET = 0.0 (0.0, 0.0) ml/kg vs. control = 2.1 (0.0, 9.7) ml/kg, p = 0.017). Body weight-adjusted estimated intraoperative blood loss was significantly lower in the SET group (SET = 0.8 (0.2, 3.5) ml/kg vs. control = 5.6 (3.4, 21.5) ml/kg, p < 0.001). In addition, the operative time was lower in the SET group with borderline statistical significance (SET = 105 (85.0, 125.0) vs. control = 130 (101.3, 167.5), p = 0.039). CONCLUSION Utilization of a sterile exsanguination tourniquet (SET) significantly reduced an estimated intraoperative blood loss while preventing the need for blood transfusion after pediatric orthopedic femoral-related surgeries. Trial registration TCTR20220412003.
PICO Summary
Population
Paediatric patients aged 3 to 18 undergoing elective femoral-related surgery (n= 31).
Intervention
Sterile exsanguination tourniquet (SET), (SET group, n= 15).
Comparison
No SET (Control group, n= 16).
Outcome
The primary outcomes were perioperative total blood loss (TBL) and transfusion rate at 72 hours after surgery. There was a borderline statistically significant lower body weight-adjusted TBL in the SET group (SET= 14.1 (7.7, 16.9) ml/kg vs. control 18.3 (14.8, 37.2) ml/kg). The body weight-adjusted transfusion volume was statistically significantly greater in the control group (SET= 0.0 (0.0, 0.0) ml/kg vs. control= 2.1 (0.0, 9.7) ml/kg). Body weight-adjusted estimated intraoperative blood loss was significantly lower in the SET group (SET= 0.8 (0.2, 3.5) ml/kg vs. control= 5.6 (3.4, 21.5) ml/kg). The operative time was lower in the SET group with borderline statistical significance (SET= 105 (85.0, 125.0) vs. control= 130 (101.3, 167.5)).
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8.
Interventions for reducing red blood cell transfusion in adults undergoing hip fracture surgery: an overview of systematic reviews
Lewis, S. R., Pritchard, M. W., Estcourt, L. J., Stanworth, S. J., Griffin, X. L.
The Cochrane database of systematic reviews. 2023;6(6):Cd013737
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Editor's Choice
Abstract
BACKGROUND Following hip fracture, people sustain an acute blood loss caused by the injury and subsequent surgery. Because the majority of hip fractures occur in older adults, blood loss may be compounded by pre-existing anaemia. Allogenic blood transfusions (ABT) may be given before, during, and after surgery to correct chronic anaemia or acute blood loss. However, there is uncertainty about the benefit-risk ratio for ABT. This is a potentially scarce resource, with availability of blood products sometimes uncertain. Other strategies from Patient Blood Management may prevent or minimise blood loss and avoid administration of ABT. OBJECTIVES To summarise the evidence from Cochrane Reviews and other systematic reviews of randomised or quasi-randomised trials evaluating the effects of pharmacological and non-pharmacological interventions, administered perioperatively, on reducing blood loss, anaemia, and the need for ABT in adults undergoing hip fracture surgery. METHODS In January 2022, we searched the Cochrane Library, MEDLINE, Embase, and five other databases for systematic reviews of randomised controlled trials (RCTs) of interventions given to prevent or minimise blood loss, treat the effects of anaemia, and reduce the need for ABT, in adults undergoing hip fracture surgery. We searched for pharmacological interventions (fibrinogen, factor VIIa and factor XIII, desmopressin, antifibrinolytics, fibrin and non-fibrin sealants and glue, agents to reverse the effects of anticoagulants, erythropoiesis agents, iron, vitamin B12, and folate replacement therapy) and non-pharmacological interventions (surgical approaches to reduce or manage blood loss, intraoperative cell salvage and autologous blood transfusion, temperature management, and oxygen therapy). We used Cochrane methodology, and assessed the methodological quality of included reviews using AMSTAR 2. We assessed the degree of overlap of RCTs between reviews. Because overlap was very high, we used a hierarchical approach to select reviews from which to report data; we compared the findings of selected reviews with findings from the other reviews. Outcomes were: number of people requiring ABT, volume of transfused blood (measured as units of packed red blood cells (PRC)), postoperative delirium, adverse events, activities of daily living (ADL), health-related quality of life (HRQoL), and mortality. MAIN RESULTS We found 26 systematic reviews including 36 RCTs (3923 participants), which only evaluated tranexamic acid and iron. We found no reviews of other pharmacological interventions or any non-pharmacological interventions. Tranexamic acid (17 reviews, 29 eligible RCTs) We selected reviews with the most recent search date, and which included data for the most outcomes. The methodological quality of these reviews was low. However, the findings were largely consistent across reviews. One review included 24 RCTs, with participants who had internal fixation or arthroplasty for different types of hip fracture. Tranexamic acid was given intravenously or topically during the perioperative period. In this review, based on a control group risk of 451 people per 1000, 194 fewer people per 1000 probably require ABT after receiving tranexamic acid (risk ratio (RR) 0.56, 95% confidence interval (CI) 0.46 to 0.68; 21 studies, 2148 participants; moderate-certainty evidence). We downgraded the certainty for possible publication bias. Review authors found that there was probably little or no difference in the risks of adverse events, reported as deep vein thrombosis (RR 1.16, 95% CI 0.74 to 1.81; 22 studies), pulmonary embolism (RR 1.01, 95% CI 0.36 to 2.86; 9 studies), myocardial infarction (RR 1.00, 95% CI 0.23 to 4.33; 8 studies), cerebrovascular accident (RR 1.45, 95% CI 0.56 to 3.70; 8 studies), or death (RR 1.01, 95% CI 0.70 to 1.46; 10 studies). We judged evidence from these outcomes to be moderate certainty, downgraded for imprecision. Another review, with a similarly broad inclusion criteria, included 10 studies, and found that tranexamic acid probably reduces the volume of transfused PRC (0.53 fewer units, 95% CI 0.27 to 0.80; 7 studies, 813 participants; moderate-certainty evidence). We downgraded the certainty because of unexplained high levels of statistical heterogeneity. No reviews reported outcomes of postoperative delirium, ADL, or HRQoL. Iron (9 reviews, 7 eligible RCTs) Whilst all reviews included studies in hip fracture populations, most also included other surgical populations. The most current, direct evidence was reported in two RCTs, with 403 participants with hip fracture; iron was given intravenously, starting preoperatively. This review did not include evidence for iron with erythropoietin. The methodological quality of this review was low. In this review, there was low-certainty evidence from two studies (403 participants) that there may be little or no difference according to whether intravenous iron was given in: the number of people who required ABT (RR 0.90, 95% CI 0.73 to 1.11), the volume of transfused blood (MD -0.07 units of PRC, 95% CI -0.31 to 0.17), infection (RR 0.99, 95% CI 0.55 to 1.80), or mortality within 30 days (RR 1.06, 95% CI 0.53 to 2.13). There may be little or no difference in delirium (25 events in the iron group compared to 26 events in control group; 1 study, 303 participants; low-certainty evidence). We are very unsure whether there was any difference in HRQoL, since it was reported without an effect estimate. The findings were largely consistent across reviews. We downgraded the evidence for imprecision, because studies included few participants, and the wide CIs indicated possible benefit and harm. No reviews reported outcomes of cognitive dysfunction, ADL, or HRQoL. AUTHORS' CONCLUSIONS Tranexamic acid probably reduces the need for ABT in adults undergoing hip fracture surgery, and there is probably little or no difference in adverse events. For iron, there may be little or no difference in overall clinical effects, but this finding is limited by evidence from only a few small studies. Reviews of these treatments did not adequately include patient-reported outcome measures (PROMS), and evidence for their effectiveness remains incomplete. We were unable to effectively explore the impact of timing and route of administration between reviews. A lack of systematic reviews for other types of pharmacological or any non-pharmacological interventions to reduce the need for ABT indicates a need for further evidence syntheses to explore this. Methodologically sound evidence syntheses should include PROMS within four months of surgery.
PICO Summary
Population
Adults undergoing hip fracture surgery (26 systematic reviews, n= 3,923).
Intervention
Pharmacological and non-pharmacological interventions to prevent or minimise blood loss, treat the effects of anaemia, and reduce the need for allogenic blood transfusions (ABT).
Comparison
Between and within categories of intervention, standard of care or placebo.
Outcome
17 reviews were found about tranexamic acid, 9 reviews about iron, and none for any other types of treatment. The three reviews providing the most relevant information were: A review about tranexamic acid including 24 studies with 2,148 people with a broken hip; a review about tranexamic acid including 10 studies with 1,123 people; and a review about iron including 2 studies with 403 people. The authors concluded that tranexamic acid probably reduces the need for ABT in adults undergoing hip fracture surgery, and there is probably little or no difference in adverse events. For iron, there may be little or no difference in overall clinical effects, but this finding is limited by evidence from only a few small studies. Reviews of these treatments did not adequately include patient-reported outcome measures, and evidence for their effectiveness remains incomplete.
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Using tranexamic acid for an additional 24 hours postoperatively in hip and knee arthroplasty saves money: a cost analysis from the TRAC-24 randomized control trial
Karayiannis PN, Agus A, Bryce L, Hill JC, Beverland D
Bone & joint open. 2022;3(7):536-542
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Editor's Choice
Abstract
AIMS: Tranexamic acid (TXA) is now commonly used in major surgical operations including orthopaedics. The TRAC-24 randomized control trial (RCT) aimed to assess if an additional 24 hours of TXA postoperatively in primary total hip (THA) and total knee arthroplasty (TKA) reduced blood loss. Contrary to other orthopaedic studies to date, this trial included high-risk patients. This paper presents the results of a cost analysis undertaken alongside this RCT. METHODS TRAC-24 was a prospective RCT on patients undergoing TKA and THA. Three groups were included: Group 1 received 1 g intravenous (IV) TXA perioperatively and an additional 24-hour postoperative oral regime, Group 2 received only the perioperative dose, and Group 3 did not receive TXA. Cost analysis was performed out to day 90. RESULTS Group 1 was associated with the lowest mean total costs, followed by Group 2 and then Group 3. The differences between Groups 1 and 3 (-£797.77 (95% confidence interval -1,478.22 to -117.32) were statistically significant. Extended oral dosing reduced costs for patients undergoing THA but not TKA. The reduced costs in Groups 1 and 2 resulted from reduced length of stay, readmission rates, emergency department attendances, and blood transfusions. CONCLUSION This study demonstrated significant cost savings when using TXA in primary THA or TKA. Extended oral dosing reduced costs further in THA but not TKA. Cite this article: Bone Jt Open 2022;3(7):536-542.
PICO Summary
Population
Patients undergoing primary total hip (THA) and total knee arthroplasty (TKA) enrolled in the TRAC-24 trial (n= 1,081).
Intervention
Intravenous perioperative dose of tranexamic acid (TXA) and an additional 24-hour post-operative oral regime (Group 1, n= 471).
Comparison
Intravenous perioperative dose of TXA (Group 2, n= 476). Standard care (Group 3, n= 134).
Outcome
Cost analysis was performed from the day of surgery until 90 days post-surgery. Group 1 was associated with the lowest mean total costs, followed by Group 2 and then Group 3. The difference between Groups 1 and 3 (-£797.77) was statistically significant. Extended oral dosing reduced costs for patients undergoing THA but not TKA. The reduced costs in Groups 1 and 2 resulted from reduced length of stay, readmission rates, emergency department attendances, and blood transfusions.
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Preemptive antifibrinolysis: its role and efficacy in hip-fracture patients undergoing total hip arthroplasty
Liu J, Lei Y, Liao J, Liang X, Hu N, Huang W
The Journal of arthroplasty. 2021
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Editor's Choice
Abstract
BACKGROUND We aimed to determine the efficacy of preemptive antifibrinolysis with tranexamic acid (TXA) in decreasing hidden blood loss (HBL) in the elderly hip fracture patients. METHODS 96 elderly hip fracture patients receiving hip arthroplasty were randomized to receive 100 ml of normal-saline (Group A) or 1.5 g of TXA (Group B) intravenously q12h from post-admission day 1 (PAD1) to the day before surgery. Both groups were treated with 1.5 g of TXA q12h from postoperative day 1 (POD1) to POD3. HBL was calculated by formulas and recorded as the primary outcome. RESULTS In overall analyses, no difference was found in HBL, while the decline-of-hemoglobin (ΔHb), allogeneic-blood-transfusion (ABT) rate, fibrinogen-degradation-product (FDP, on PAD2, PAD3, POD1 and POD2) and D-dimer (D-D, on PAD2, PAD3 and POD1) were lower in Group B. In subgroup analyses for patients receiving intervention within 72 hours of injury, Group B had lower postoperative HBL, ΔHb, ABT rate, FDP and D-D levels (on PAD2, PAD3, POD1 and POD2). For patients receiving intervention over 72 hours after injury, no difference was detected in perioperative HBL, ΔHb, ABT rate between the two groups. The FDP and D-D levels were lower in Group B on PAD2 and PAD3. No difference was found in coagulation parameters, wound complications, VTE rate and 90-day mortality in all analyses. CONCLUSION Early administration (within 72 hours of injury) of multi-dose of TXA is effective in reducing perioperative HBL in elderly hip fracture patients. Delayed use (over 72 hours after injury) of TXA was not beneficial.
PICO Summary
Population
Elderly hip fracture patients undergoing total hip arthroplasty (n= 96).
Intervention
Intravenous tranexamic acid (TXA) every 12 hours from post-admission day to the day before surgery (n= 48).
Comparison
Normal saline (n= 48).
Outcome
No difference was found in hidden blood loss, while the decline-of-haemoglobin (ΔHb), allogeneic-blood-transfusion (ABT) rate, fibrinogen-degradation-product and D-dimer were lower in patients receiving TXA. For patients receiving intervention over 72 hours after injury, no difference was detected in perioperative hidden blood loss, ΔHb, ABT rate between the two groups. No difference was found in coagulation parameters, wound complications, venous thromboembolism rate and 90-day mortality.