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Randomized prospective comparative study of platelet-rich plasma versus conventional compression in treatment of post-phlebitic venous ulcer
Shehab AW, Eleshra A, Fouda E, Elwakeel H, Farag M
Vascular. 2022;:17085381221104629
Abstract
OBJECTIVES to assess the safety and efficacy of platelet-rich plasma (PRP) as adjunctive to compression therapy for post-phlebitic venous ulcers. METHODS This is a single-center randomized controlled trial on patients with persistent chronic post-phlebitic lower limb venous ulcers from March 2019 to March 2020. Patients were randomly allocated to one of two equal cohort groups. Patients group in which patients underwent combined PRP with compression therapy versus control group in which patients underwent placebo+ compression therapy alone. The primary endpoint of the study was the improvement in ulcer topographic measurement. Secondary endpoints included ulcer healing parameters, possible healing factors, reduction in pain score (VAS), and the achievement of complete healing. RESULTS Forty patients were available equally for randomization and analysis in both groups. The median number of PRP applications for every patient in the patient group was 6 (ranging from 3 to 6). There was a significant decline in the median length, width, and depth of ulcers in the patients group versus control group. Consequently, there was a significant decline of the median ulcer area, in the patient group versus control group (4 (3-9) cm(2) vs. 10 (6-14) cm(2), p = .036). Also, the median volume of the ulcers showed a significant decline in the patient group versus control group (1 (.7-3) cm(3) vs 3 (2-6) cm(3), p = .008). Complete healing was achieved in 45% of patient group. There was a significant decline in pain scores at 3- and 6 months from the therapy starting point in both groups (patient group: pre-VAS = 6.5 vs. post(3 months)-VAS = 1 vs. post(6 months)-VAS = 0.5) and (control group: pre-VAS = 6.4 vs. post(3 months)-VAS = 4.5 vs. post(6 months)-VAS = 2.2), (p < .0001 for each). On the other hand, the decline in pain scores between both groups was statistically significant in favor of the patient group, (post (3 months); PRP-VAS = 1 vs. control-VAS = 4.5, and post(6 months); PRP-VAS = 0.5 vs. control-VAS = 2.2), (p < .0001). CONCLUSION Platelet-rich plasma as an adjunct to compression therapy for chronic post-phlebitic venous ulcers is safe and effective as regards the ulcer healing and improvement of pain score. PRP may be useful adjunct in treatment of post-phlebitic venous ulcer. However, larger trials are warranted.
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Impact of restrictive red blood cell transfusion strategy on thrombosis-related events: A meta-analysis and systematic review
Maimaitiming M, Zhang C, Xie J, Zheng Z, Luo H, Ooi OC
Vox sanguinis. 2022
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Editor's Choice
Abstract
BACKGROUND AND OBJECTIVES There is an ongoing controversy regarding the risks of restrictive and liberal red blood cell (RBC) transfusion strategies. This meta-analysis assessed whether transfusion at a lower threshold was superior to transfusion at a higher threshold, with regard to thrombosis-related events, that is, whether these outcomes can benefit from a restrictive transfusion strategy is debated. MATERIALS AND METHODS We searched PubMed, Cochrane Central Register of Controlled Trials and Scopus from inception up to 31 July 2021. We included randomized controlled trials (RCTs) in any clinical setting that evaluated the effects of restrictive versus liberal RBC transfusion in adults. We used random-effects models to calculate the risk ratios (RRs) and 95% confidence intervals (CIs) based on pooled data. RESULTS Thirty RCTs involving 17,334 participants were included. The pooled RR for thromboembolic events was 0.65 (95% CI 0.44-0.94; p = 0.020; I(2) = 0.0%, very low-quality evidence), favouring the restrictive strategy. There were no significant differences in cerebrovascular accidents (RR = 0.83; 95% CI 0.64-1.09; p = 0.180; I(2) = 0.0%, very low-quality evidence) or myocardial infarction (RR = 1.05; 95% CI 0.87-1.26; p = 0.620; I(2) = 0.0%, low-quality evidence). Subgroup analyses showed that a restrictive (relative to liberal) strategy reduced (1) thromboembolic events in RCTs conducted in North America and (2) myocardial infarctions in the subgroup of RCTs where the restrictive transfusion threshold was 7 g/dl but not in the 8 g/dl subgroup (with a liberal transfusion threshold of 10 g/dl in both subgroups). CONCLUSIONS A restrictive (relative to liberal) transfusion strategy may be effective in reducing venous thrombosis but not arterial thrombosis.
PICO Summary
Population
Adult patients in any clinical setting (30 studies, n= 17,334).
Intervention
Restrictive red blood cell transfusion.
Comparison
Liberal red blood cell transfusion.
Outcome
The pooled risk ratio (RR) for thromboembolic events was 0.65 (very low-quality evidence), favouring the restrictive strategy. There were no significant differences in cerebrovascular accidents (RR= 0.83, very low-quality evidence) or myocardial infarction (RR= 1.05, low-quality evidence). Subgroup analyses showed that a restrictive (relative to liberal) strategy reduced thromboembolic events in trials conducted in North America, and myocardial infarctions in the subgroup of trials where the restrictive transfusion threshold was 7 g/dl but not in the 8 g/dl subgroup (with a liberal transfusion threshold of 10 g/dl in both subgroups).
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Transfusion strategies in patients with acute coronary syndrome and anemia: a meta-analysis
Nasir U, Waheed TA, Ahuja KR, Sandhu CS, Ameen M, Hope EJ
The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology. 2022;74(1):17
Abstract
BACKGROUND Anemia is a known risk factor for ischemic heart disease and serves as an independent predictor of major adverse cardiovascular events (MACE) in patients with acute coronary syndrome (ACS). This meta-analysis pools data from randomized controlled trials (RCTs) to better define hemoglobin (Hb) thresholds for transfusion in this setting. RESULTS MEDLINE, EMBASE, and Cochrane databases were searched using the terms "Acute Coronary Syndrome" AND "Blood Transfusion" including their synonyms. A total of three randomized controlled trials were included. Restrictive transfusion strategy (RTS) was defined as transfusing for Hb ≤ 8 g/dl with a post-transfusion goal of 8 to 10 g/dl. Liberal transfusion strategy (LTS) was defined as Hb ≤ 10 g/dl and post-transfusion goal of at least 11 g/dl. The primary end point was 30-day mortality. Secondary outcomes included recurrent ACS events, new or worsening CHF within 30 days, and major adverse cardiac events (MACE). The primary analytic method used was random effects model. Out of 821 patients, 400 were randomized to LTS, and 421 to RTS. Mean age was 70.3 years in RTS versus 76.4 in LTS. There was no statistically significant difference for 30-day mortality in LTS compared to RTS [odds ratio (OR) 1.69; 95% CI 0.35 to 8.05]. Similarly, there was no difference in MACE (OR 0.74; 95% CI 0.21 to 2.63), CHF (OR 0.82; 95% CI 0.18 to 3.76), or the incidence of recurrent ACS (OR 1.21; 95% CI 0.49 to 2.95). CONCLUSIONS In the setting of ACS, there is no difference between LTS and RTS for the outcomes of mortality, MACE, recurrent ACS, or CHF at 30 days. Further evidence in the form of high-quality RCTs are needed to compare RTS and LTS.
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The effect of platelet-rich plasma-fibrin glue dressing in combination with oral vitamin E and C for treatment of non-healing diabetic foot ulcers: A randomized, double-blind, parallel-group, clinical trial
Yarahmadi A, Saeed Modaghegh MH, Mostafavi-Pour Z, Azarpira N, Mousavian A, Bonakdaran S, Jarahi L, Samadi A, Peimani M, Hamidi Alamdari D
Expert opinion on biological therapy. 2021
Abstract
OBJECTIVE The current study assesses the effects of platelet-rich plasma-fibrin glue (PRP-FG) dressing along with oral vitamin E and C on wound healing and biochemical markers in patients with non-healing diabetic foot ulcers (non-healing DFU). METHODS This randomized, double-blind, placebo-controlled trial was performed on twenty-five patients with non-healing DFU. Patients were treated with PRP-FG dressing plus oral vitamin E and C (intervention group) or PRP-FG dressing plus placebo (control group) for eight weeks. RESULTS Eight weeks after treatment, six wounds in the intervention group and two wounds in the control group were completely closed, and also wound size significantly reduced in both intervention (-9.7 ± 6.9 cm(2), p = 0.002), and control (-5.6 ± 5.4 cm(2), p = 0.003) groups. This reduction in wound size was significantly greater in the intervention group compared to the control group (p = 0.019). Also, a significant decrease in prooxidant-antioxidant balance (PAB) index, ESR, and hs-CRP were observed in the intervention group compared to the control group (p < 0.05). CONCLUSION Results of this trial showed that PRP-FG dressing along with oral vitamin E and C could be used to increase wound healing in patients with non-healing DFU by enhancing the wound healing process and reducing oxidative stress. TRIAL REGISTRATION This trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04315909).
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Effect of a Restrictive vs Liberal Blood Transfusion Strategy on Major Cardiovascular Events Among Patients With Acute Myocardial Infarction and Anemia: The REALITY Randomized Clinical Trial
Ducrocq G, Gonzalez-Juanatey JR, Puymirat E, Lemesle G, Cachanado M, Durand-Zaleski I, Arnaiz JA, Martínez-Sellés M, Silvain J, Ariza-Solé A, et al
Jama. 2021;325(6):552-560
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Editor's Choice
Abstract
IMPORTANCE The optimal transfusion strategy in patients with acute myocardial infarction and anemia is unclear. OBJECTIVE To determine whether a restrictive transfusion strategy would be clinically noninferior to a liberal strategy. DESIGN, SETTING, AND PARTICIPANTS Open-label, noninferiority, randomized trial conducted in 35 hospitals in France and Spain including 668 patients with myocardial infarction and hemoglobin level between 7 and 10 g/dL. Enrollment could be considered at any time during the index admission for myocardial infarction. The first participant was enrolled in March 2016 and the last was enrolled in September 2019. The final 30-day follow-up was accrued in November 2019. INTERVENTIONS Patients were randomly assigned to undergo a restrictive (transfusion triggered by hemoglobin ≤8; n = 342) or a liberal (transfusion triggered by hemoglobin ≤10 g/dL; n = 324) transfusion strategy. MAIN OUTCOMES AND MEASURES The primary clinical outcome was major adverse cardiovascular events (MACE; composite of all-cause death, stroke, recurrent myocardial infarction, or emergency revascularization prompted by ischemia) at 30 days. Noninferiority required that the upper bound of the 1-sided 97.5% CI for the relative risk of the primary outcome be less than 1.25. The secondary outcomes included the individual components of the primary outcome. RESULTS Among 668 patients who were randomized, 666 patients (median [interquartile range] age, 77 [69-84] years; 281 [42.2%] women) completed the 30-day follow-up, including 342 in the restrictive transfusion group (122 [35.7%] received transfusion; 342 total units of packed red blood cells transfused) and 324 in the liberal transfusion group (323 [99.7%] received transfusion; 758 total units transfused). At 30 days, MACE occurred in 36 patients (11.0% [95% CI, 7.5%-14.6%]) in the restrictive group and in 45 patients (14.0% [95% CI, 10.0%-17.9%]) in the liberal group (difference, -3.0% [95% CI, -8.4% to 2.4%]). The relative risk of the primary outcome was 0.79 (1-sided 97.5% CI, 0.00-1.19), meeting the prespecified noninferiority criterion. In the restrictive vs liberal group, all-cause death occurred in 5.6% vs 7.7% of patients, recurrent myocardial infarction occurred in 2.1% vs 3.1%, emergency revascularization prompted by ischemia occurred in 1.5% vs 1.9%, and nonfatal ischemic stroke occurred in 0.6% of patients in both groups. CONCLUSIONS AND RELEVANCE Among patients with acute myocardial infarction and anemia, a restrictive compared with a liberal transfusion strategy resulted in a noninferior rate of MACE after 30 days. However, the CI included what may be a clinically important harm. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02648113.
PICO Summary
Population
Patients with myocardial infarction enrolled in the REALITY trial (n= 668).
Intervention
Restrictive transfusion strategy, haemoglobin <8 g/dL (n= 342).
Comparison
Liberal transfusion strategy, haemoglobin <10 g/dL (n = 324).
Outcome
Among the patients in the restrictive transfusion group, 122 (35.7%) received transfusion, compared to 323 (99.7%) patients in the liberal transfusion group. At 30 days, major adverse cardiovascular events occurred in 36 patients (11.0%) in the restrictive group and in 45 patients (14.0%) in the liberal group. In the restrictive vs. liberal group, all-cause death occurred in 5.6% vs. 7.7% of patients, recurrent myocardial infarction occurred in 2.1% vs. 3.1%, emergency revascularization prompted by ischemia occurred in 1.5% vs. 1.9%, and nonfatal ischemic stroke occurred in 0.6% of patients in both groups.
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Evaluation of the efficacy of platelet-rich plasma on healing of clean diabetic foot ulcers: A randomized clinical trial in Tehran, Iran
Malekpour Alamdari N, Shafiee A, Mirmohseni A, Besharat S
Diabetes & metabolic syndrome. 2021;15(2):621-626
Abstract
BACKGROUND AND AIMS Diabetic foot ulcers (DFUs) are among challenging hurdles both for the patient and the physician. There is a recent trend toward finding novel and clinically efficient modalities to treat this potentially hazardous complication of diabetes mellitus in a timely manner. Herein, we aim to appraise the efficacy of platelet-rich plasma (PRP) in healing of clean DFUs. METHODS 90 patients with clean DFUs consisting of 56 (62.2%) males and 34 (37.8%) females with mean age (±standard deviation) of 56.52 (±7.14) years were enrolled in this study between June 2017 and December 2018. They were randomly allocated into control group (47 patients who received conventional dressing along with silver sulfadiazine ointment twice daily), and case group (43 patients who received PRP gel twice weekly for 3 weeks). All the patients were followed up for 6 months. RESULTS Our study showed that PRP significantly increased the healing rate of DFUs regardless of the age (p-value: 0.0), gender (p-value: 0.0), or smoking (p-value: 0.0) and blood pressure (p-value: 0.0) status of patients, but it did not have a significant impact on the need for amputation (p-value: 0.11), level of amputation (p-value: 0.16), or the need for further treatments such as graft or angioplasty (p-value: 0.52). CONCLUSION Regardless of the age, gender, or smoking and blood pressure status of patients, PRP can be efficiently used in diabetic patients to accelerate the healing rate of foot ulcers.
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Clinical studies on platelet-rich plasma (PRP) therapy for chronic cutaneous ulcers: a systematic review and meta-analysis of randomized controlled trials
Qu S, Hu Z, Zhang Y, Wang P, Li S, Huang S, Dong Y, Xu H, Rong Y, Zhu W, et al
Advances in wound care. 2021
Abstract
SIGNIFICANCE Platelet-rich plasma (PRP) may be a potential drug for treatment of chronic refractory ulcers, which increase the risk of systemic infection and local canceration. However, the efficacy and safety of clinical application of PRP are still controversial. Thus, this study was aimed to assess the efficacy and safety of PRP in patients with chronic ulcers. Recent Advances: For this meta-analysis, Cochrane's Library, MEDLINE, EMBASE, PubMed, and Web of Knowledge databases were searched. Results were pooled using a random-effects model. The primary outcome was the proportion of completely healed chronic ulcers. CRITICAL ISSUES Seventeen randomized controlled trials (RCTs) were included. Compared with the control group, PRP significantly increased the fraction of healed ulcers (pooled RR =1.50; 95% CI 1.20 to 1.87; I2=47.8%). In autologous PRP (APRP) and homologous PRP (HPRP) subgroups, there were statistical differences between the control group vs. treatment subgroup (pooled RR=1.30, 95% CI 1.10 to 1.54, I2=25.7%; pooled RR=3.53, 95% CI 1.94 to 6.43, I2=0.0%, respectively). In terms of percent of chronic ulcers area healed, there was a statistically significant difference between the PRP-treated group vs. the control group (SMD=1.37, 95%CI=0.91 to 1.82, I2=22.1 %). As for PRP safety, there existed a statistically significant difference between the APRP subgroup and the HPRP subgroup, respectively (pooled RR=0.58; 95% CI 0.35 to 0.98; I2=0.0%) and (pooled RR=4.12; 95% CI 1.55 to 10.96; I2=6.8%). FUTURE DIRECTIONS Our findings shows that PRP may be a beneficial treatment of chronic skin ulcers and that APRP may be much safer than HPRP.
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The Effectiveness and Safety of Platelet-Rich Plasma for Chronic Wounds: A Systematic Review and Meta-analysis
Qu W, Wang Z, Hunt C, Morrow AS, Urtecho M, Amin M, Shah S, Hasan B, Abd-Rabu R, Ashmore Z, et al
Mayo Clinic proceedings. 2021
Abstract
OBJECTIVE To evaluate the effectiveness and adverse events of autologous platelet-rich plasma (PRP) in individuals with lower-extremity diabetic ulcers, lower-extremity venous ulcers, and pressure ulcers. PATIENTS AND METHODS We searched multiple databases from database inception to June 11, 2020, for randomized controlled trials and observational studies that compared PRP to any other wound care without PRP in adults with lower-extremity diabetic ulcers, lower-extremity venous ulcers, and pressure ulcers. RESULTS We included 20 randomized controlled trials and five observational studies. Compared with management without PRP, PRP therapy significantly increased complete wound closure in lower-extremity diabetic ulcers (relative risk, 1.20; 95% CI, 1.09 to 1.32, moderate strength of evidence [SOE]), shortened time to complete wound closure, and reduced wound area and depth (low SOE). No significant changes were found in terms of wound infection, amputation, wound recurrence, or hospitalization. In patients with lower-extremity venous ulcers or pressure ulcers, the SOE was insufficient to estimate an effect on critical outcomes, such as complete wound closure or time to complete wound closure. There was no statistically significant difference in adverse events. CONCLUSION Autologous PRP may increase complete wound closure, shorten healing time, and reduce wound size in individuals with lower-extremity diabetic ulcers. The evidence is insufficient to estimate an effect on wound healing in individuals with lower-extremity venous ulcers or pressure ulcers. TRIAL REGISTRATION PROSPERO Identifier: CRD42020172817.
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Objective assessment of Platelet-Rich Plasma (PRP) potentiality in the treatment of Chronic leg Ulcer: RCT on 80 patients with Venous ulcer
Helmy Y, Farouk N, Ali Dahy A, Abu-Elsoud A, Fouad Khattab R, Elshahat Mohammed S, Abdullbary Gad L, Altramsy A, Hussein E, Farahat A
Journal of cosmetic dermatology. 2021;20(10):3257-3263
Abstract
BACKGROUND Chronic venous leg ulcer reduces the patients' activities and their overall quality of life. Platelet-rich plasma (PRP) was previously investigated as promising less invasive management for leg ulcers. THIS STUDY AIMS To re-assess the efficacy and safety of PRP in the management of chronic leg ulcers due to venous factors. PATIENTS/METHODS RCT enrolled 80 patients who clinically presented with chronic venous leg ulcers. Forty patients were allocated randomly for the treatment with autologous platelet-rich plasma (PRP). Intradermal and subdermal injection of PRP by 27guage syringe weekly, in all edges and in the granular floor of the ulcer for 4-6 sessions. Another 40 patients managed by conventional treatment by compression and dressing for the same period were allocated as Group B. Objective assessment achieved by the percentage of reduction of the size of the ulcer area, rate of healing, incidence of recurrence, and if side effects have been reported. RESULTS PRP therapy showed better results and high p value significance when compared to conventional therapy. CONCLUSION This study shows that PRP is effective and significant in promoting the wound healing process in chronic leg venous ulcers. PRP is simple, safe, and has a short learning curve technique.
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Restrictive vs. Liberal Red Blood Cell Transfusion Strategy in Patients With Acute Myocardial Infarction and Anemia: A Systematic Review and Meta-Analysis
Zhang Y, Xu Z, Huang Y, Ye Q, Xie N, Zeng L, Lian X, Dai Y, Chen J, He P, et al
Frontiers in cardiovascular medicine. 2021;8:736163
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Free full text
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Editor's Choice
Abstract
Objective: Anemia is frequent in patients with acute myocardial infarction (AMI), and the optimal red blood cell transfusion strategy for AMI patients with anemia is still controversial. We aimed to compare the efficacy of restrictive and liberal red cell transfusion strategies in AMI patients with anemia. Methods: We systematically searched PubMed, EMBASE, Web of Science, Cochrane Library, and Clinicaltrials.gov, from their inception until March 2021. Studies designed to compare the efficacy between restrictive and liberal red blood cell transfusion strategies in patients with AMI were included. The primary outcome was all-cause mortality, including overall mortality, in-hospital or follow-up mortality. Risk ratios (RR) with 95% confidence intervals (CI) were presented and pooled by random-effects models. Results: The search yielded a total of 6,630 participants in six studies. A total of 2,008 patients received restrictive red blood cell transfusion while 4,622 patients were given liberal red blood cell transfusion. No difference was found in overall mortality and follow-up mortality between restrictive and liberal transfusion groups (RR = 1.07, 95% CI = 0.82-1.40, P = 0.62; RR = 0.89, 95% CI = 0.56-1.42, P = 0.62). However, restrictive transfusion tended to have a higher risk of in-hospital mortality compared with liberal transfusion (RR = 1.22, 95% CI = 1.00-1.50, P = 0.05). No secondary outcomes, including follow-up reinfarction, stroke, and acute heart failure, differed significantly between the two groups. In addition, subgroup analysis showed no differences in overall mortality between the two groups based on sample size and design. Conclusion: Restrictive and liberal red blood cell transfusion have a similar effect on overall mortality and follow-up mortality in AMI patients with anemia. However, restrictive transfusion tended to have a higher risk of in-hospital mortality compared with liberal transfusion. The findings suggest that transfusion strategy should be further evaluated in future studies.
