Clinical Effectiveness of Intraoperative Tranexamic Acid Use in Shoulder Surgery: A Systematic Review and Meta-analysis
The American journal of sports medicine. 2021;:363546520981679
BACKGROUND Tranexamic acid (TXA) is widely used across surgical specialties to reduce perioperative bleeding. It has been shown to be effective in spinal surgery and lower limb arthroplasty. Among all languages, there are no systematic reviews or meta-analyses investigating its clinical effectiveness for all types of shoulder surgery. PURPOSE To investigate the clinical effectiveness of TXA in all types of shoulder surgery, including open and arthroscopic procedures. To investigate the effect of TXA on bleeding and non-bleeding-related outcomes. STUDY DESIGN Systematic review and meta-analysis. METHODS A protocol for the study was designed and registered with PROSPERO (CRD42020185482). The literature search included the MEDLINE, Embase, PsycINFO, and Cochrane Library databases. All randomized controlled trials evaluating the use of TXA against placebo, in all types of shoulder surgery, were included. Assessments were undertaken for risk of bias and certainty of evidence. The primary outcome was total blood loss. Secondary outcomes included those not directly related to bleeding. Data from comparable outcomes were pooled and analyzed quantitatively or descriptively, as appropriate. RESULTS Eight randomized controlled trials were included in the systematic review, and data from 7 of these studies were pooled in the meta-analysis. Pooled analysis demonstrated a significant reduction in 2 of 3 outcomes measuring perioperative bleeding with TXA compared with controls: estimated total blood loss (mean difference, -209.66 mL; 95% CI, -389.11 to -30.21; P = .02) and postoperative blood loss as measured by drain output (mean difference, -84.8 mL; 95% CI, -140.04 to -29.56; P = .003). Hemoglobin reduction was reduced but not statistically significant (mean difference, -0.33 g/dL; 95% CI -0.69 to 0.03; P = .07). This result became significant with sensitivity analysis excluding arthroscopic procedures. CONCLUSION This systematic review and meta-analysis indicated that TXA was effective in reducing blood loss in shoulder surgery. Larger randomized controlled trials with low risk of bias for specific surgical shoulder procedures are required. CLINICAL RELEVANCE TXA can be used across shoulder surgery to reduced perioperative blood loss. The use of TXA may have other beneficial features, including reduced postoperative pain and reduced operative time.
Experiences and outcomes of women with bleeding in early pregnancy presenting to the Emergency Department: An integrative review
Australasian emergency care. 2021
BACKGROUND Bleeding in early pregnancy occurs in approximately a quarter of all pregnancies and is a common reason for presentation to the Emergency Department (ED). This review combined current knowledge about experiences, interventions, outcomes and frequency of women presenting to the ED with per vaginal (PV) bleeding in the first 20 weeks of pregnancy. METHODS This integrative literature review was conducted using electronic database and hand searching methods for primary research published from 2000; followed by screening and appraisal. Articles were compared and grouped to identify characteristics and patterns that guided the synthesis of categories. RESULTS Forty-two primary research articles met inclusion criteria. Four main categories related to experiences and outcomes of women with bleeding in early pregnancy presenting to the ED were identified: presentation frequency and characteristics; women and their partners' experiences in the ED; interventions and treatments; patient and health service outcomes. CONCLUSIONS Negative and often frustrating experiences are reported by women experiencing PV bleeding, their partners and ED healthcare providers. While strategies such as early pregnancy assessment services contribute to improved outcomes, the availability of these services vary. Further research is needed to identify specific needs of this group of women and their partners, and the staff providing their care in the ED, to inform strategies for improved quality of care.
Association of Umbilical Cord Management Strategies With Outcomes of Preterm Infants: A Systematic Review and Network Meta-analysis
JAMA pediatrics. 2021;:e210102
IMPORTANCE It is unclear which umbilical cord management strategy is the best for preventing mortality and morbidities in preterm infants. OBJECTIVE To systematically review and conduct a network meta-analysis comparing 4 umbilical cord management strategies for preterm infants: immediate umbilical cord clamping (ICC), delayed umbilical cord clamping (DCC), umbilical cord milking (UCM), and UCM and DCC. DATA SOURCES PubMed, Embase, CINAHL, and Cochrane CENTRAL databases were searched from inception until September 11, 2020. STUDY SELECTION Randomized clinical trials comparing different umbilical cord management strategies for preterm infants were included. DATA EXTRACTION AND SYNTHESIS Data were extracted for bayesian random-effects meta-analysis to estimate the relative treatment effects (odds ratios [OR] and 95% credible intervals [CrI]) and surface under the cumulative ranking curve values. MAIN OUTCOMES AND MEASURES The primary outcome was predischarge mortality. The secondary outcomes were intraventricular hemorrhage, severe intraventricular hemorrhage, need for packed red blood cell transfusion, and other neonatal morbidities. Confidence in network meta-analysis software was used to assess the quality of evidence and grade outcomes. RESULTS Fifty-six studies enrolled 6852 preterm infants. Compared with ICC, DCC was associated with lower odds of mortality (22 trials, 3083 participants; 7.6% vs 5.0%; OR, 0.64; 95% CrI, 0.39-0.99), intraventricular hemorrhage (25 trials, 3316 participants; 17.8% vs 15.4%; OR, 0.73; 95% CrI, 0.54-0.97), and need for packed red blood cell transfusion (18 trials, 2904 participants; 46.9% vs 38.3%; OR, 0.48; 95% CrI, 0.32-0.66). Compared with ICC, UCM was associated with lower odds of intraventricular hemorrhage (10 trials, 645 participants; 22.5% vs 16.2%; OR, 0.58; 95% CrI, 0.38-0.84) and need for packed red blood cell transfusion (9 trials, 688 participants; 47.3% vs 32.3%; OR, 0.36; 95% CrI, 0.23-0.53), with no significant differences for other secondary outcomes. There was no significant difference between UCM and DCC for any outcome. CONCLUSIONS AND RELEVANCE Compared with ICC, DCC was associated with the lower odds of mortality in preterm infants. Compared with ICC, DCC and UCM were associated with reductions in intraventricular hemorrhage and need for packed red cell transfusion. There was no significant difference between UCM and DCC for any outcome. Further studies directly comparing DCC and UCM are needed.
Clinical evaluation of the treatment of multiple gingival recessions with connective tissue graft or concentrated growth factor using tunnel technique: a randomized controlled clinical trial
Clinical oral investigations. 2021
OBJECTIVE To assess the effectiveness of the combination of tunnel technique (TT) and concentrated growth factor (CGF) for root coverage in treating multiple gingival recessions (GR) and compare with the connective tissue graft (CTG). MATERIALS AND METHODS Forty patients with Miller Class I and II maxillary or mandibular GR were randomly divided into two groups as follows: TT + CTG and TT + CGF. The results at baseline and 6 months were evaluated for the following clinical parameters: complete root coverage (CRC), mean root coverage (MRC), gingival thickness (GT), gingival recession width (RW), gingival recession depth (RD), and keratinized tissue width (KTW). RESULTS At 6 months, a statistically significant difference was found in RD, RW, MRC, CRC, KTW, and GT compared with the baseline (p < 0.05). MRC was determined 89.52±16.36% in the TT + CTG and 76.60±24.10% in the TT + CGF (p < 0.05). CRC was achieved in 66.7% of the TT + CTG and 47.4% of the TT + CGF (p < 0.05). The increase in KTW and GT was significantly better in the TT + CTG group compared to the TT + CGF (p < 0.05). CONCLUSIONS The study showed that TT + CGF did not improve the results as much as TT + CTG in the treatment of Miller Class I and II GR. However, this finding is not sufficient to advocate the true clinical effects of CGF on GR treatment with TT. CLINICAL RELEVANCE CGF could not serve as a direct alternative biomaterial to the gold standard CTG. TRIAL REGISTRATION ClinicalTrials.gov Identification Number: NCT04561947.
Intravenous iron supplementation after liver surgery: Impact on anemia, iron, and hepcidin levels-a randomized controlled trial
BACKGROUND Anemia is a recognized risk factor for perioperative related morbidity and mortality and is frequently reported in liver surgeries with an estimated incidence of 32%. We aim to assess the impact of intravenous iron administration in the immediate postoperative period on anemia and iron status as well as to determine the kinetics of hepcidin after liver surgery. METHODS The HepciFer trial, a randomized controlled trial, included 50 patients undergoing liver surgery. In accordance with the randomization process, patients received either ferric carboxymaltose (15 mg/kg, maximum 1 g) or placebo 4 hours after surgery. RESULTS The mean hemoglobin level, 7 days after surgery, did not differ significantly between the intervention and control group (11.1 ± 1.8 g/dL and 10.4 ± 1.6 g/dL, respectively) with a mean difference of +0.7 g/dL ([95% confidence interval, -0.3 to +1.7], P = .173). Within patients receiving intravenous iron supplementation, none presented biological signs of functional iron deficiency. Hepcidin levels remained significantly higher during the observation period in the intervention group. Inflammatory biomarkers, red blood cells transfusion rate and hospital duration of stay were similar between groups. CONCLUSION Intravenous ferric carboxymaltose administration did not result in a significant increase of hemoglobin levels 7 days after surgery. However, this study suggests that intravenous iron supplementation in the immediate postoperative settings prevents functional iron deficiency. Intravenous iron supplementation overcame the hepcidin-mediated blockade of iron absorption and should be considered as the preferred route of administration in the postoperative period.
Safety and Efficacy of Intravenous Ferric Derisomaltose Compared to Iron Sucrose for Iron Deficiency Anemia in Patients with Chronic Kidney Disease With and Without Heart Failure
The American journal of cardiology. 2021
Ferric derisomaltose (FDI) is an intravenous (IV) high-dose iron formulation approved in the US for the treatment of iron deficiency anemia in adults who are intolerant of/have had an unsatisfactory response to oral iron, or who have non-dialysis-dependent chronic kidney disease (NDD-CKD). FERWON-NEPHRO was a randomized, open-label, multicenter clinical trial evaluating the safety and efficacy of a single infusion of FDI 1,000 mg versus up to 5 doses of iron sucrose (IS) 200 mg (recommended cumulative dose, 1,000 mg) over 8 weeks in patients with NDD-CKD and iron deficiency anemia. Of 1,525 patients included in the safety analysis, 244 (16%) had a history of heart failure (HF). Overall, the rate of serious or severe hypersensitivity reactions was low and did not differ between treatment groups. Cardiovascular adverse events (AEs) were reported for 9.4% of patients who had HF and 4.2% who did not. Time to first cardiovascular AE was longer following administration of FDI compared with IS (hazard ratio: 0.59 [95% CI: 0.37, 0.92]; p=0.0185), a difference that was similar in patients with or without HF (p=0.908 for interaction). Patients achieved a faster hematological response (assessed by changes in hemoglobin and ferritin concentrations, and increase in transferrin saturation) with FDI versus IS. In conclusion, in patients with NDD-CKD, a single infusion of FDI was safe, well tolerated, and was associated with fewer cardiovascular AEs and a faster hematological response, compared to multiple doses of IS. These effects were similar for patients with and without HF.
Effect of 4DryField® PH on blood loss in hip bipolar hemiarthroplasty following intracapsular femoral neck fracture - a randomized clinical trial
BMC musculoskeletal disorders. 2021;22(1):113
BACKGROUND One of the most common complications of hip arthroplasty is excessive blood loss that could necessitate allogenic blood transfusion, which is further associated with other complications, such as infections, transfusion reactions or immunomodulation. In gynecology, 4DryField®PH, an absorbable polysaccharide-based formulation, is used for hemostasis and adhesion prophylaxis. In this study, we evaluated its hemostatic effect in patients undergoing hip bipolar hemiarthroplasty following intracapsular femoral neck fracture. METHODS We studied 40 patients with intracapsular femoral neck fractures (Garden III or IV) admitted at our institution between July 2016 and November 2017. We included patients above 60 years with simple fracture and without pathologic fractures. Patients were randomized into intervention and control groups. The intervention group received 5 g of 4DryField® PH (subfascially and subcutaneously) during wound closure. Three drainages were inserted in a standardized manner (submuscular, subfascial, and subcutaneous) and drainage volume was measured immediately before extraction. Total blood loss was calculated using Mercuriali's formula and standard hemograms upon admission and five days after surgery. Volume of postoperative hematoma was measured using point-of-care ultrasound seven days after surgery. RESULTS Volume of the postoperative hematoma was reduced by 43.0 mL. However, significant reduction of total blood loss and drainage volume was not observed. CONCLUSIONS We observed that 4DryField® PH had a local hemostatic effect, thereby reducing volume of the postoperative hematoma. However, this reduction was small and had no effect on the total blood loss. Further studies are warranted to improve the application algorithm. TRIAL REGISTRATION DRKS, DRKS00017452 , Registered 11 June 2019 - Retrospectively registered.
Disease-modifying treatments for primary autoimmune haemolytic anaemia
The Cochrane database of systematic reviews. 2021;3:Cd012493
BACKGROUND Primary autoimmune haemolytic anaemia (AIHA) is an autoantibody mediated condition characterised by a variable disease course. A myriad of immunomodulatory agents have been employed but there is a paucity of evidence to support their use or compare their effectiveness. OBJECTIVES To determine the effects of various disease-modifying treatment modalities in people with AHIHA. SEARCH METHODS We searched MEDLINE (Ovid) (1946 to 2021), Embase (Ovid) (1974 to 2021), Latin American and Caribbean Health Sciences Literature (LILACS) (1982 to 2021), and the Cochrane Library (CENTRAL). Clinical trial registries and relevant conference proceedings were also reviewed. Records were included as of 7 March 2021. We did not impose any language restrictions. SELECTION CRITERIA Randomised controlled trials (RCTs) comparing immunosuppressive or immunomodulatory treatments against no treatment, placebo, or another immunosuppressive or immunomodulatory treatment, for people of all age with idiopathic AIHA. DATA COLLECTION AND ANALYSIS We used standard methodological procedures expected by Cochrane. The prioritised pre-defined outcomes included complete haematological response at 12 months, frequency of adverse events at two, six and 12 months, partial haematological response at 12 months, overall survival at six and 12 months, relapse-free survival (RFS) at six and 12 months, red blood cel (RBC) transfusion requirement after treatment at 12 months, and quality of life (QOL) as measured by validated instruments at 12 months. Based on data availability, we were only able to perform meta-analysis on frequency of complete haematological response. MAIN RESULTS Two trials were included, enrolling a total of 104 adult participants (96 randomised) with warm AIHA in the setting of tertiary referral centres, both comparing the effectiveness between rituximab (375 mg/m(2) weekly for four weeks, or 1000 mg for two doses two weeks apart) plus glucocorticoid (prednisolone 1.5 or 1mg/kg/day with taper) and glucocorticoid monotherapy. The average age of participants in the two trials were 67 and 71, respectively. One of the included studies had good methodological quality with low risk of bias, whereas the other study had high risk of performance and detection bias due to lack of blinding. Compared with glucocorticoid alone, adding rituximab may result in a large increase of complete response at 12 months (n = 96, risk ratio (RR) 2.13, 95% confidence interval (CI) 1.34 to 3.40, GRADE low-certainty evidence). Rates of adverse effects at prespecified time-points were not reported. Limited data on partial haematological response were reported. The evidence is very uncertain about the effect of adding rituximab to glucocorticoids on partial haematological response at 12 months (n = 32; study = 1; RR 3.00, 95% CI 0.13 to 68.57; GRADE very low-certainty evidence). RBC transfusion need at 12 months was reported in one study, with four participants (mean number of packed red cell units 4.0 ± 2.82) from the rituximab group and five participants from the placebo (corticosteroid only) (mean number of packed red cell units 5.6 ± 4.15) group requiring transfusion, indicating very uncertain evidence about the effect of adding rituximab to glucocorticoids (n = 32, RR 0.80, 95% CI 0.26 to 2.45, GRADE very low-certainty evidence). The other study did not report transfusion requirement at prespecified time points but reported no difference in transfusion requirement between the two groups when comparing responders from enrolment to end of response or to the end of study follow-up (34 units versus 30 units, median [range]: 0 [1 to 6] versus 0 [1 to 5], P = 0·81). Overall survival and RFS rates at prespecified time-points were not explicitly reported in either study. Data on QOL were not available. AUTHORS' CONCLUSIONS Available literature on the effectiveness of immunomodulatory therapy for primary AIHA is restricted to comparison between rituximab plus glucocorticoid and glucocorticoid alone, in patients with newly diagnosed warm AIHA, calling for need for additional studies. The current result suggests that combinatory therapy with rituximab and glucocorticoid may increase the rate of complete haematological response over glucocorticoid monotherapy.
Primary autoimmune haemolytic anaemia (AIHA) patients (2 studies, n= 104).
Rituximab plus glucocorticoid.
Compared with glucocorticoid alone, adding rituximab may result in a large increase of complete response at 12 months. Rates of adverse effects at pre-specified time-points were not reported. The evidence is very uncertain about the effect of adding rituximab to glucocorticoids on partial haematological response at 12 months. Red blood cell transfusion need at 12 months was reported in one study. The other study did not report transfusion requirement at pre-specified time points but reported no difference in transfusion requirement between the two groups.
Lack of Cost-Effectiveness of Preoperative Erythropoiesis-Stimulating Agents and/or Iron Therapy in Anaemic, Elective Surgery Patients: A Systematic Review and Updated Analysis
OBJECTIVES For anaemic elective surgery patients, current clinical practice guidelines weakly recommend the routine use of iron, but not erythrocyte-stimulating agents (ESAs), except for short-acting ESAs in major orthopaedic surgery. This recommendation is, however, not based on any cost-effectiveness studies. The aim of this research was to (1) systematically review the literature regarding cost effectiveness of preoperative iron and/or ESAs in anaemic, elective surgery patients and (2) update existing economic evaluations (EEs) with recent data. METHODS Eight databases and registries were searched for EEs and randomized controlled trials (RCTs) reporting cost-effectiveness data on November 11, 2020. Data were extracted, narratively synthesized and critically appraised using the Philips reporting checklist. Pre-existing full EEs were updated with effectiveness data from a recent systematic review and current cost data. Incremental cost-effectiveness ratios were expressed as cost per (quality-adjusted) life-year [(QA)LY] gained. RESULTS Only five studies (4 EEs and 1 RCT) were included, one on intravenous iron and four on ESAs + oral iron. The EE on intravenous iron only had an in-hospital time horizon. Therefore, cost effectiveness of preoperative iron remains uncertain. The three EEs on ESAs had a lifetime time horizon, but reported cost per (QA)LY gained of 20-65 million (GBP or CAD). Updating these analyses with current data confirmed ESAs to have a cost per (QA)LY gained of 3.5-120 million (GBP or CAD). CONCLUSIONS Cost effectiveness of preoperative iron is unproven, whereas routine preoperative ESA therapy cannot be considered cost effective in elective surgery, based on the limited available data. Future guidelines should reflect these findings.
Elective surgery patients with anaemia (5 studies).
Erythrocyte-stimulating agents (ESAs) and oral iron.
The economic evaluation on intravenous iron only had an in-hospital time horizon. Cost effectiveness of preoperative iron remained uncertain. The three economic evaluations on ESAs had a lifetime time horizon, but reported cost per (QA)LY gained of 20-65 million (GBP or CAD). Updating these analyses with current data confirmed ESAs to have a cost per (QA)LY gained of 3.5-120 million (GBP or CAD).
Efficacy of Platelet-Rich Plasma in Enhancing the Osteogenic Potential of Bone Graft in Oral and Maxillofacial Region
Journal of maxillofacial and oral surgery. 2021;20(2):282-295
BACKGROUND Platelet-rich plasma (PRP) has been a breakthrough in the stimulation and acceleration of bone and soft tissue healing. It represents a relatively new biotechnology that is part of the growing interest in tissue engineering and cellular therapy. METHODS A prospective study was carried out in 50 patients. The cases were selected randomly in the age group of 8-50 years who needed bone grafts for alveolar cleft defects and surgical defects following removal of osteolytic jaw lesions. They were divided into study group with autologous PRP and control group without PRP. Bone density was calculated as per Hounsfield scale preoperatively and post-operatively for both the groups. RESULTS There was significant difference in the Hounsfield units at 06 months and 12 months post-operatively in both the groups showing good amount of bone regeneration. The preoperative volume of the defect and the post-operative volume of the regenerated bone were statistically analysed. The mean V2 was 0.7652 cc for the study group, whereas for control group, it was 0.4840 cc. The volume ratio for study group was 0.9070 and for control group was 0.6740. This showed greater bone regeneration in the study group. The results were statistically significant for both the groups. CONCLUSION PRP is a new application of tissue engineering and a developing area of interest for clinicians and researchers. It is a storage vehicle for growth factors, especially PDGF and TGF-b, both of which influence bone regeneration, and also eliminates the concerns about immunogenic reactions and disease transmission. PRP does enhance the healing of bone grafts in the maxillofacial region as shown by the increase in the density of bone.