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1.
Intravenous tranexamic acid reduce postoperative drainage and pain after open elbow arthrolysis: A randomized controlled trial
Cui H, Yu S, Ruan J, Sun Z, Li J, Chen S, Fan C
Journal of shoulder and elbow surgery. 2021
Abstract
BACKGROUND Open elbow arthrolysis (OEA), which has become an established treatment for post-traumatic elbow stiffness (PTES), requires complete release of contracture tissue and wide excision of ectopic bone, which results in extensive bleeding. The aim of the present study is to evaluate the efficacy of intravenous tranexamic acid (TXA) on postoperative drainage, calculated blood loss and early clinical outcomes in patients undergoing OEA. METHODS A double-blind, randomized, placebo-controlled trial including 96 patients undergoing OEA was undertaken. Patients received intravenously either 100 mL saline (placebo group, n = 48), or 100 mL saline plus 1 g TXA (TXA group, n = 48) before skin incision. The primary outcome was the drainage volume on postoperative day (POD) 1 to 3. Secondary outcomes included the calculated blood loss, elbow pain score measured by Visual Analog Scale (VAS), elbow function valued by Mayo Elbow Performance Score (MEPS), and rate of complications after OEA. RESULTS Mean total postoperative drainage volume (TXA group: 182 mL vs. placebo group: 214 mL, p = 0.003) and mean calculated total blood loss (TXA group: 582 mL vs. placebo group: 657 mL, p = 0.004) were significantly lower in the TXA group. No transfusions were necessary in either group. Mean VAS pain scores in elbow motion showed marked differences between both groups on POD 1 (TXA: 5 vs. placebo: 6, p = 0.003) and POD 2 (TXA: 4 vs. placebo: 5, p = 0.023), but not in other postoperative time points. No differences were detected in complications, such as pin-related infection, hematoma, new or exacerbation of ulnar nerve symptoms, and recurrent heterotopic ossification. At the 6-month follow-up, no statistical differences were found between the two groups with respect to the elbow functions including range of motion, VAS score and MEPS. CONCLUSION Intravenous administration of TXA significantly decreased the postoperative drainage volume and the total estimated blood loss, and alleviated the elbow pain with motion during early postoperative days in patients undergoing OEA. LEVEL OF EVIDENCE Level I; Randomized Controlled Trial; Treatment Study.
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2.
A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures
Durdevic D, Vlahovic T, Pehar S, Miklic D, Oppermann H, Bordukalo-Niksic T, Gavrankapetanovic I, Jamakosmanovic M, Milosevic M, Martinovic S, et al
Bone. 2020;:115551
Abstract
Bone morphogenetic proteins (BMPs) are known to induce new bone formation in vivo but treating trabecular bone defects with a BMP based therapeutic remains controversial. Here, we evaluated the safety and efficacy of a novel Autologous Bone Graft Substitute (ABGS) comprised of recombinant human BMP6 (rhBMP6) dispersed within an autologous blood coagulum (ABC) as a physiological natural carrier in patients with a closed distal radial fracture (DRF). We enrolled 32 patients in a randomized, standard of care (SoC) and placebo (PBO) controlled, double-blinded Phase I First in Human (FiH) clinical trial. ABGS was prepared from peripheral blood as 250 μg rhBMP6/mL ABC or PBO (1 mL ABC containing excipients only) and was administered dorsally via a syringe injection into the fracture site following closed fracture fixation with 3 Kirschner wires. Patients carried an immobilization for 5 weeks and were followed-up for 0 to 26 weeks by clinical examination, safety, serial radiographic analyses and CT. During the 13 weeks follow-up and at 26 weeks post study there were no serious adverse reactions recorded. The results showed that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 32 patients at 13- and 26-weeks following treatment. Pharmacokinetic analyses of plasma from patients treated with ABGS showed no detectable rhBMP6 at any time point within the first 24 hours following administration. The CT image and radiographic analyses score from patients treated with AGBS showed significantly accelerated bone healing as compared to PBO and SoC at 5 and 9 weeks (with high effect sizes and P=0.027), while at week 13 all patients had similar healing outcomes. In conclusion, we show that intraosseous administration of ABGS (250 μg rhBMP6/mL ABC) into the distal radial fracture site demonstrated a good tolerability with no serious adverse reactions as well as early accelerated trabecular bone healing as compared to control PBO and SoC patients.
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3.
The safety of modern intravenous iron infusions in patients with rheumatoid arthritis - a review of the literature
Ooi M, Hibbs S, Chen FE
Hematology (Amsterdam, Netherlands). 2020;25(1):108-111
Abstract
Objectives: To assess the evidence for the safety of intravenous iron infusions in patients with rheumatoid arthritis.Methods: A systematic literature search was performed in June 2019 on PubMed and Cochrane databases for eligible studies.Results: There is significant evidence of safety and efficacy of intravenous iron in patients with rheumatoid arthritis using newer, less immunogenic iron preparations, such as iron sucrose and low molecular weight iron dextran preparations.Discussion: Iron deficiency anaemia has a significant impact on the quality of life of patients with rheumatoid arthritis, but the use of intravenous iron is generally avoided due to concerns raisedin older studies using high molecular weight iron dextran of exacerbating the disease. However, such concerns have not been confirmed in more recent studies using newer preparations.Conclusion: We find significant evidence of safety and efficacy in more recent studies of larger cohorts of patients using newer, less immunogenic iron preparations.
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4.
The effect of intravenous iron on erythropoiesis in older people with hip fracture
Moppett IK, Rowlands M, Mannings AM, Marufu TC, Sahota O, Yeung J
Age and ageing. 2019
Abstract
BACKGROUND anaemia following hip fracture is common and associated with worse outcomes. Intravenous iron is a potential non-transfusion treatment for this anaemia and has been found to reduce transfusion rates in previous observational studies. There is good evidence for its use in elective surgical populations. OBJECTIVE to examine the impact of intravenous iron on erythropoiesis following hip fracture. DESIGN two-centre, assessor-blinded, randomised, controlled trial of patients with primary hip fracture and no contra-indications to intravenous iron. METHOD the intervention group received three doses of 200 mg iron sucrose over 30 min (Venofer, Vifor Pharma, Bagshot Park, UK) on three separate days. Primary outcome was reticulocyte count at day 7 after randomisation. Secondary outcomes included haemoglobin concentration, complications and discharge destination. Eighty participants were randomised. RESULTS there was a statistically significantly greater absolute final reticulocyte count in the iron group (89.4 (78.9-101.3) x 109 cells l-1 (n = 39) vs. the control (72.2 (63.9-86.4)) x 109 cells l-1 (n = 41); P = 0.019; (mean (95% confidence intervals) of log-transformed data). There were no differences in final haemoglobin concentration (99.9 (95.7-104.2) vs. 102.0 (98.7-105.3) P = 0.454) or transfusion requirements in the first week (11 (28%) vs. 12 (29%); P = 0.899). Functional and safety outcomes were not different between the groups. CONCLUSIONS although intravenous iron does stimulate erythropoiesis following hip fracture in older people, the effect is too small and too late to affect transfusion rates. Trial Registry Numbers: ISRCTN76424792; EuDRACT 2011-003233-34.
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5.
The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review
Minniti MC, Statkevich AP, Kelly RL, Rigsby VP, Exline MM, Rhon DI, Clewley D
The American journal of sports medicine. 2019;:363546519882652
Abstract
BACKGROUND The effectiveness of blood flow restriction training (BFRT) as compared with other forms of training, such as resistance training, has been evaluated in the literature in clinical and nonclinical populations. However, the safety of this intervention has been summarized only in healthy populations and not in clinical populations with musculoskeletal disorders. PURPOSE To evaluate the safety and adverse events associated with BFRT in patients with musculoskeletal disorders. STUDY DESIGN Systematic review. METHODS A literature search was conducted with 3 online databases (MEDLINE, CINAHL, and Embase). Eligibility criteria for selecting studies were as follows: (1) BFRT was used as a clinical intervention, (2) study participants had a disorder of the musculoskeletal system, (3) authors addressed adverse events, (4) studies were published in English, and (5) the intervention was performed with human participants. RESULTS Nineteen studies met eligibility criteria, with a pooled sample size of 322. Diagnoses included various knee-related disorders, inclusion body myositis, polymyositis or dermatomyositis, thoracic outlet syndrome, Achilles tendon rupture, and bony fractures. Nine studies reported no adverse events, while 3 reported rare adverse events, including an upper extremity deep vein thrombosis and rhabdomyolysis. Three case studies reported common adverse events, including acute muscle pain and acute muscle fatigue. In the randomized controlled trials, individuals exposed to BFRT were not more likely to have an adverse event than individuals exposed to exercise alone. Of the 19 studies, the adverse events were as follows: overall, 14 of 322; rare overall, 3 of 322; rare BFRT, 3 of 168; rare control, 0 of 154; any adverse BFRT, 10 of 168; any adverse control, 4 of 154. A majority of studies were excluded because they did not address safety. CONCLUSION BFRT appears to be a safe strengthening approach for knee-related musculoskeletal disorders, but further research is needed to make definitive conclusions and to evaluate the safety in other musculoskeletal conditions. Improved definitions of adverse events related to BFRT are needed to include clear criteria for differentiating among common, uncommon, and rare adverse events. Finally, further research is needed to effectively screen who might be at risk for rare adverse events.
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6.
Efficacy and safety of topical tranexamic acid in knee arthroplasty
Lopez-Hualda A, Dauder-Gallego C, Ferreno-Marquez D, Martinez-Martin J
Medicina Clinica. 2018;151((11):):431-434
Abstract
INTRODUCTION AND OBJECTIVE Tranexamic acid (TXA) is commonly used to control postoperative blood loss in total knee arthroplasty. In order to avoid adverse effects associated with intravenous administration, topical use has been proposed as an alternative. Our aim was to evaluate the efficacy and safety of topical TXA in total knee arthroplasty. MATERIAL AND METHODS A total of 90 patients scheduled for unilateral total knee arthroplasty were included in a prospective randomised study. All surgeries were performed under spinal anaesthesia, tourniquet and the same postoperative protocol. Patients were allocated to one of the 3 groups according to the application of TXA: group A (n=30) 1g of topical TXA; group B (n=30) 1g of TXA intravenous and in group C or the control group (n=30) no drug was administrated. Parameters related to blood loss and drain outputs were compared between the 3 groups. RESULTS The results revealed that post-operative decrease in haemoglobin level was significantly lower in group A (1.95g/dL) than group B (2.25g/dL) and group C (2.96g/dL), P<.01. Total postoperative blood loss was lower in group A (195mL) than group B (466mL) and group C (718mL), P<.01. There was no significant difference in complications and allogenic blood transfusion rate between the 3 groups. CONCLUSIONS According to the results, topical application of 1g TXA significantly reduced blood loss in patients undergoing total knee arthroplasty more than intravenous or no administration of TXA.
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7.
Tranexamic acid administration for anatomic and reverse total shoulder arthroplasty: a systematic review and meta-analysis
Box, H. N., Tisano, B. S., Khazzam, M.
JSES open access. 2018;2(1):28-33
Abstract
Background: Tranexamic acid (TXA) has been shown to reduce perioperative blood loss and risk of blood transfusion. Evidence establishing its efficacy in total shoulder arthroplasty (TSA) is limited. The current study evaluated the effect of TXA on perioperative blood loss and transfusion risk after TSA. Methods: A systematic review and meta-analysis of TXA administration for TSA was performed, and 6 studies with a total of 680 patients were found. Data on change in hemoglobin, drain output, total blood loss, and transfusion were extracted. Meta-analysis was performed with stratification into reverse and anatomic TSA subgroups. Results: TXA administration was associated with decreased change in hemoglobin (-0.63 g/dL; 95% CI, -0.87 to -0.39 g/dL; P < .00001), drain output (-112.05 mL; 95% CI, -182.29 to -41.81 mL; P < .0001), and total blood loss (-231.87 mL; 95% CI, -334.23 to -129.48 mL; P < .00001) after reverse TSA. There was a trend toward reduction in transfusion rate after reverse TSA (-4%; 95% CI, -8% to 0%; P = .06). TXA administration was associated with reduced drain output after anatomic TSA (-123.07 mL; 95% CI, -163.93 to -82.20 mL; P < 0.00001). TXA administration was not associated with decreased transfusion rate after anatomic TSA. Data to evaluate the effect of TXA on change in hemoglobin and total blood loss after anatomic TSA were insufficient. Conclusions: Routine administration of TXA reduces perioperative blood loss and may reduce the risk of transfusion after reverse TSA. Future studies are needed to further characterize its effect on the risk of transfusion after reverse TSA and efficacy in anatomic TSA.
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8.
The efficacy and safety of multiple-dose oral tranexamic acid on blood loss following total hip arthroplasty: a randomized controlled trial
Cao G, Huang Q, Huang Z, Zhang S, Luo Z, Lei Y, Zhou Z, Pei F
International Orthopaedics. 2018
Abstract
PURPOSES To explore the efficacy and safety of multiple-dose oral tranexamic acid (TXA) on blood loss following primary total hip arthroplasty (THA). METHODS A total of 152 patients were randomized into three groups to receive 2 g of oral TXA two hours pre-operatively (group A), or another bolus of 2 g of oral TXA four hours post-operatively (group B), or another three boluses of 2 g of oral TXA four, ten, and 16 hours post-operatively (group C). The primary outcomes were total blood loss (TBL), hidden blood loss (HBL), and transfusion rate. The secondary outcomes were haemoglobin (Hb) and haematocrit (Hct) drop, the level of fibrinolysis parameters (fibrin degradation products, D-dimer), and complications (thrombotic diseases, stroke, cardiac infarction, and infection). RESULTS The mean TBL and HBL in group C were lower than those in group A (p < 0.001 and p < 0.001) and group B (p = 0.012 and p = 0.029). The Hb drop on post-operative day one (POD1) and POD3 in group C was lower than those in group A (p < 0.001 and p = 0.029) and group B (p < 0.001 and p = 0.004). The difference was similar regarding Hct drop on POD3 (p < 0.001 and p = 0.014). Moreover, fibrin degradation products and D-dimer in group C were lower than in groups A and B on POD1 and POD3 (p < 0.001 and p < 0.001). The incidence of complications such as venous thromboembolism did not differ significantly among the three groups (p > 0.05). CONCLUSIONS Multiple boluses of oral TXA could further reduce blood loss, Hb and Hct drop, and restrain post-operative fibrinolysis in primary THA without increasing the risk of complications. LEVEL OF EVIDENCE I Therapeutic study.
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9.
Tranexamic acid reduces blood loss after primary shoulder arthroplasty: a double-blind, placebo-controlled, prospective, randomized controlled trial
Cvetanovich GL, Fillingham YA, O'Brien M, Forsythe B, Cole BJ, Verma NN, Romeo AA, Nicholson GP
JSES open access. 2018;2(1):23-27
Abstract
Background: Tranexamic acid (TXA) is an antifibrinolytic that has been shown to decrease blood loss and transfusion rates after hip and knee arthroplasty, with only limited evidence to support its use in shoulder arthroplasty. This study was conducted to determine whether intravenous (IV) TXA is more effective than placebo in reducing blood loss after primary total shoulder arthroplasty (TSA). Methods: In this prospective, double-blind, placebo-controlled, randomized clinical trial, patients undergoing primary anatomic and reverse TSA were randomized to receive 1 g of intravenous TXA or a placebo of an equivalent volume of intravenous normal saline administered 10 minutes before the incision. The primary outcome measurement was calculated postoperative blood loss. Secondary outcomes included transfusion rates, weight of hemoglobin loss, hospital length of stay, and thromboembolic events. Results: The study enrolled 110 patients, 2 of whom were excluded because they did not have a postoperative hemoglobin measurement, and the remaining 108 patients (52 for TXA, 56 for placebo) were analyzed. There were no significant differences between TXA and placebo groups in preoperative characteristics. For the primary outcome, the TXA group had significantly lower postoperative blood loss of 1100.9 +/- 367.4 mL compared with 1274.5 +/- 460.0 mL for the placebo group (P = .03). For secondary outcomes, TXA had lower weight of hemoglobin loss compared with placebo (152.2 +/- 57.3 g vs. 178.0 +/- 65.8 g; P = .03). No patients in the TXA or placebo groups required a transfusion. Conclusions: Intravenous TXA reduced blood loss after primary TSA compared with placebo.
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10.
A prospective assessment of outcomes following the use of autologous blood for the management of recurrent temporomandibular joint dislocation
Machon V, Levorova J, Hirjak D, Wisniewski M, Drahos M, Sidebottom A, Foltan R
Oral and Maxillofacial Surgery. 2017;22((1):):53-57
Abstract
PURPOSE The objective of the study was to compare results of treatment for chronic recurrent temporomandibular joint dislocation (CRTMD) by autologous blood injection (ABI) using two different methods of administration (combination intra- and peri-articular, and peri-articular alone). MATERIALS AND METHODS Forty patients diagnosed with CRTMD were randomly divided into two groups of 20 each (A and B). Group A were treated by intra- and peri-articular blood injection, group B were treated by peri-articular injection alone. The follow-up was done at 1, 3, 6, and 12 months. The study assessed presence of dislocations, pain (VAS, 0-10), interincisal mouth opening (IMO), and the presence of sound phenomena. The treatment was considered successful in patients without the persistence of CRTMD symptoms, as well as with a VAS of 0-1. RESULT After 12 months, a beneficial therapeutic effect in group B was seen in 11 patients, while 16 patients from group A had a therapeutic effect. CONCLUSION Intra- and peri-articular ABI is more effective than peri-articular blood application alone in the treatment of CRTMD, although the difference was not statistically significant.
