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1.
Platelet-rich plasma versus corticosteroid: a randomized controlled trial on tennis elbow patients resistant to nonsurgical treatments
Sayadi, S., Shahbazi, P., Najafi, A., Ochi, F., Jafarabady, K., Rezaei, M. M., Azarsina, S.
Annals of medicine and surgery (2012). 2023;85(9):4385-4388
Abstract
BACKGROUND Although some studies on tennis elbow indicate corticosteroid (CS) effectiveness in the short term, according to the role of race, this study evaluates the efficacy of platelet-rich plasma (PRP) compared with CS for a more cost-effective treatment. METHODS This randomized controlled trial included 30 positive-resisted wrist extension patients with a minimum five visual analog scale (VAS) pain score. Participants were randomly assigned to treatment or control groups via computer-generated randomization and were matched for baseline and clinical characteristics. Cases received either 40 mg of prednisolone acetate or 2 ml of PRP, followed for 1 month. VAS and Disabilities of the Arm, Shoulder, and Hand (DASH) scores were the primary outcomes. RESULTS The median VAS and the mean DASH scores had a statistically significant difference in the PRP and CS groups before and after injection (P<0.001).The mean DASH difference between preinjection and follow-up time in the PRP and CS groups was 59.72±14.17 and 43.16±10.87, respectively, with a mean difference of 16.55 (95% CI 7.10-26.00) and a significant difference (P=0.001).The mean VAS pain score difference in preinjection and follow-up time had a statistically significant difference between the PRP and CS groups (P=0.026), and the mean VAS pain score difference in the CS group was 6.46±1.50 and 7.73±0.96 in the PRP group. CONCLUSION In conclusion, larger studies with parallel groups and more diverse CS doses and types with baseline matching are needed to confirm the short-term benefits of PRP. Investigating the effects of different CS doses using ultrasound techniques is recommended.
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2.
Efficacy of platelet-poor plasma gel in combination with fractional CO(2) laser in striae distensae: A clinical, histological, and immunohistochemical study
Gad SE, Neinaa YME, Rizk OK, Ghaly NER
Journal of cosmetic dermatology. 2021;20(10):3236-3244
Abstract
BACKGROUND Platelet-poor plasma gel is a semi-solid plasma formulation that recently recommended as autologous bio-filler for treatment of atrophic dermal scars. AIM: To compare the therapeutic efficacy and safety of intradermal injection of plasma gel in combination with fractional CO(2) laser versus fractional CO(2) laser alone in striae distensae (SD). PATIENTS AND METHODS This study included 36 SD patients treated by three sessions (one session/1.5 months) of fractional CO(2) laser on all SD lesions following intradermal injection of plasma gel on one side and saline (as placebo) on the other side. RESULTS Significant clinical improvements associated with remarkable narrowing of SD lesions and prominent enhancement of skin texture were observed on both treatment sides. Obviously, higher degrees of clinical improvements of SD lesions were reported following combined therapy with fractional CO(2) laser and plasma gel rather than fractional CO(2) laser monotherapy. However, post-inflammatory hyperpigmentation (PIH) was reported more frequently with fractional CO(2) laser monotherapy. Histopathological and immunohistochemical examinations revealed significant epidermal improvement, and homogenization, and orientation of dermal collagen bundles as a result of both therapeutic procedures. CONCLUSION Plasma gel in combination with fractional CO(2) laser could be considered a promising novel treatment modality for SD. Plasma gel not only improves the efficacy of fractional CO(2) laser but also decreases the frequency of PIH.
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3.
Evaluation of Safety and Efficacy of Autologous Topical Platelet Gel versus Platelet Rich Plasma Injection in the Treatment of Venous Leg Ulcers: A randomized case control study
Elgarhy LH, El-Ashmawy AA, Bedeer AE, Al Bahnassy AM
Dermatol Ther. 2020
Abstract
Various management options were tried for Chronic venous leg ulcers (VLUs) with no satisfactory results. Platelet-rich plasma (PRP) is promising in enhancing chronic wound healing by releasing various growth factors. We evaluated the safety and efficacy of topical platelet gel (PG) versus PRP injection in treatment of venous leg ulcers. 20 patients were treated with topical PG (group I), 20 patients received PRP injection (group II) and 20 patients were treated with saline dressing and compression as controls (group III) weekly for 6 weeks. Ulcer improvement was evaluated by pressure ulcer scale for healing (PUSH). Histopathological evaluation and immunohistochemical staining using anti-CD34 were performed before and after treatment. There was significant improvement in PUSH score in group (I) and group (II) compared to group (III) (P-value:0.001). However, there was no statistically significant difference in improvement between group I and II (P-value = 0.83). However, topical PG was more effective in diabetics and PRP was more effective in long standing fibrosed ulcers. Histopathology showed reduction of the inflammatory cells infiltrates and well-formed granulation tissue with no difference in immunostaining. So, both topical PG and PRP injection were effective, low cost and safe procedures in enhancing healing of chronic VLUs. This article is protected by copyright. All rights reserved.
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4.
Predictors and Clinical Outcomes of Poor Platelet Recovery in Adult Dengue With Thrombocytopenia: A Multicenter, Prospective Study
Archuleta, S., Chia, P. Y., Wei, Y., Syed-Omar, S. F., Low, J. G., Oh, H. M., Fisher, D., Ponnampalavanar, S. S. L., Wijaya, L., Kamarulzaman, A., et al
Clinical Infectious Diseases : An Official Publication of the Infectious Diseases Society of America. 2020;71(2):383-389
Abstract
BACKGROUND Platelet transfusion is common in dengue patients with thrombocytopenia. We previously showed in a randomized clinical trial that prophylactic platelet transfusion did not reduce clinical bleeding. In this study, we aimed to characterize the predictors and clinical outcomes of poor platelet recovery in transfused and nontransfused participants. METHODS We analyzed patients from the Adult Dengue Platelet Study with laboratory-confirmed dengue with ≤20 000 platelets/μL and without persistent mild bleeding or any severe bleeding in a post hoc analysis. Poor platelet recovery was defined as a platelet count of ≤20 000/μL on Day 2. We recruited 372 participants from 5 acute care hospitals located in Singapore and Malaysia between 29 April 2010 and 9 December 2014. Of these, 188 were randomly assigned to the transfusion group and 184 to the control group. RESULTS Of 360 patients, 158 had poor platelet recovery. Age, white cell count, and day of illness at study enrollment were significant predictors of poor platelet recovery after adjustment for baseline characteristics and platelet transfusion. Patients with poor platelet recovery had longer hospitalizations but no significant difference in other clinical outcomes, regardless of transfusion. We found a significant interaction between platelet recovery and transfusion; patients with poor platelet recovery were more likely to bleed if given a prophylactic platelet transfusion (odds ratio 2.34, 95% confidence interval 1.18-4.63). CONCLUSIONS Dengue patients with thrombocytopenia who were older or presented earlier and with lower white cell counts were more likely to have poor platelet recovery. In patients with poor platelet recovery, platelet transfusion does not improve outcomes and may actually increase the risk of bleeding. The mechanisms of poor platelet recovery need to be determined. CLINICAL TRIALS REGISTRATION NCT01030211.
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5.
Regeneration of chronic wounds with allogeneic platelet gel versus hydrogel treatment: A prospective study
Semenic D, Cirman T, Rozman P, Smrke DM
Acta clinica Croatica. 2018;57(3):434-442
Abstract
- The aim of the study was to evaluate the efficacy and safety of the new method of platelet-rich plasma activation in the form of platelet gel, used in the treatment of non-healing chronic lower leg ulcers. The study was prospectively randomized, double blind and placebo controlled. We treated 60 patients (42 males and 18 females, mean age 69.43 years, SD 14.74) with chronic lower leg ulcers of different etiologies. Thirty patients were treated with allogeneic platelet gel and 30 with hydrogel. Both groups were comparable for duration of ulcer and its size. Treatment was repeated once a week for three consecutive weeks and then the last examination was scheduled at 6 months of the first platelet gel application. The t-test was used to analyze independent samples. Healing of chronic wounds with platelet gel was statistically significantly more effective compared to the treatment with hydrogel (p<0.05). At 6 months of platelet gel application, the mean wound area in the experimental group decreased to 35.01% (SD 53.69) of the initial wound size. In the control group, the wound area decreased to 89.95% (SD 71.82) of the initial wound size (p=0.001). The circumference of the wounds diminished to 54.62% (SD 39.85) of the initial value in the experimental group, compared to 91.28% (SD 29.32) in the control group (p<0.001). Allogeneic platelet gel prepared by the new method used in this study was found to be a good treatment option for non-healing chronic wounds when other methods are ineffective.
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6.
Pilot study of homologous platelet gel in venous ulcers
Oliveira MG, Abbade LPF, Miot HA, Ferreira RR, Deffune E
Anais Brasileiros de Dermatologia. 92(4):499-504, 2017 Jul-Aug.. 2017;92((4):):499-504
Abstract
Background:: Venous ulcers represent 70% of the lower limb ulcers. They are difficult to heal, requiring a correct diagnostic and therapeutic approach. Many products have been developed to healing, such as homologous platelet gel obtained from the platelet concentrate exceeding from blood transfusion. Objective:: To evaluate the safety and efficacy of homologous platelet gel in venous ulcers compared with hydrocolloid dressing. Method:: A pilot randomized clinical trial in patients with venous ulcers. Randomized groups (homologous platelet gel and hydrocolloid groups) were followed for 90 days and were assessed through the evolution of ulcerated area, qualitative analysis of vascularization and adverse events. Both groups used elastic compression. Results:: We included 16 participants, with a total of 21 venous ulcers. Both treatments promoted a reduction of the areas of the ulcers in 90 days (mean 69%), there was significant difference between the groups concerning the gradual reduction of the ulcers areas, favorably to the hydrocolloid (70% vs 64%; p <0.01). There were some mild adverse events in both groups. Study limitations:: Single-center study with a small number of patients, preventing more accurate assessment of the effects of platelet gel. Conclusion:: The homologous platelet gel associated with the elastic compression can be an alternative to the venous ulcer treatment and is safe due to the occurrence of a few mild local adverse events and no serious adverse events. Clinical trials with larger numbers of patients must be performed to maintain the indication of this treatment for venous ulcer.
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7.
Prophylactic platelet transfusion plus supportive care versus supportive care alone in adults with dengue and thrombocytopenia: a multicentre, open-label, randomised, superiority trial
Lye DC, Archuleta S, Syed-Omar SF, Low JG, Oh HM, Wei Y, Fisher D, Ponnampalavanar SS, Wijaya L, Lee LK, et al
Lancet (London, England). 2017;389((10079):):1611-1618. 1611
Abstract
BACKGROUND Dengue is the commonest vector-borne infection worldwide. It is often associated with thrombocytopenia, and prophylactic platelet transfusion is widely used despite the dearth of robust evidence. We aimed to assess the efficacy and safety of prophylactic platelet transfusion in the prevention of bleeding in adults with dengue and thrombocytopenia. METHODS We did an open-label, randomised, superiority trial in five hospitals in Singapore and Malaysia. We recruited patients aged at least 21 years who had laboratory-confirmed dengue (confirmed or probable) and thrombocytopenia (≤20 000 platelets per muL), without persistent mild bleeding or any severe bleeding. Patients were assigned (1:1), with randomly permuted block sizes of four or six and stratified by centre, to receive prophylactic platelet transfusion in addition to supportive care (transfusion group) or supportive care alone (control group). In the transfusion group, 4 units of pooled platelets were given each day when platelet count was 20 000 per muL or lower; supportive care consisted of bed rest, fluid therapy, and fever and pain medications. The primary endpoint was clinical bleeding (excluding petechiae) by study day 7 or hospital discharge (whichever was earlier), analysed by intention to treat. Safety outcomes were analysed according to the actual treatment received. This study was registered with ClinicalTrials.gov, number NCT01030211, and is completed. FINDINGS Between April 29, 2010, and Dec 9, 2014, we randomly assigned 372 patients to the transfusion group (n=188) or the control group (n=184). The intention-to-treat analysis included 187 patients in the transfusion group (one patient was withdrawn immediately) and 182 in the control group (one was withdrawn immediately and one did not have confirmed or probable dengue). Clinical bleeding by day 7 or hospital discharge occurred in 40 (21%) patients in the transfusion group and 48 (26%) patients in the control group (risk difference -4.98% [95% CI -15.08 to 5.34]; relative risk 0.81 [95% CI 0.56 to 1.17]; p=0.16). 13 adverse events occurred in the transfusion group and two occurred in the control group (5.81% [-4.42 to 16.01]; 6.26 [1.43 to 27.34]; p=0.0064). Adverse events that were possibly, probably, or definitely related to transfusion included three cases of urticaria, one maculopapular rash, one pruritus, and one chest pain, as well as one case each of anaphylaxis, transfusion-related acute lung injury, and fluid overload that resulted in serious adverse events. No death was reported. INTERPRETATION In adult patients with dengue and thrombocytopenia, prophylactic platelet transfusion was not superior to supportive care in preventing bleeding, and might be associated with adverse events. FUNDING National Medical Research Council, Singapore.
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8.
Statistical analysis plan for the PlAtelet Transfusion in Cerebral Haemorrhage (PATCH) trial: a multicentre randomised controlled trial
Baharoglu MI, Al-Shahi Salman R, Cordonnier C, de Haan RJ, Roos YB
Trials. 2016;17:379.
Abstract
BACKGROUND Use of antiplatelet therapy shortly before stroke due to spontaneous primary intracerebral haemorrhage (ICH) is associated with higher case fatality in comparison to ICH without prior antithrombotic drug use. The PlAtelet Transfusion in Cerebral Haemorrhage (PATCH) trial aimed to assess the effect of platelet transfusion in patients presenting with ICH while using antiplatelet therapy. The main hypothesis of PATCH was that platelet transfusion would reduce death or dependence by reducing ICH growth. METHODS/DESIGN PATCH was a multicentre prospective, randomised, open, blinded endpoint (PROBE) parallel group trial, conducted at 60 hospitals in The Netherlands, Scotland and France. Forty-one sites enrolled 190 patients with spontaneous supratentorial ICH aged ≥18 years, who had used antiplatelet therapy for ≥7 days preceding ICH, if Glasgow Coma Scale was ≥8. Participants were randomised (1:1, with a secure web-based system using permuted blocks, stratified by study centre and type of antiplatelet therapy pre-ICH) to receive either platelet transfusion within 6 hours of symptom onset and 90 minutes of diagnostic brain imaging, or standard care without platelet transfusion. The primary outcome was modified Rankin Scale (mRS) score assessed blind to treatment allocation at 3 months after ICH. Planned secondary outcomes included ICH growth on brain imaging performed approximately 24 hours after randomisation, survival at 3 months, disability at 3 months scored using the Amsterdam Medical Centre linear disability score, heterogeneity of treatment effect on mRS and ICH growth according to presence of the computed tomography angiography spot sign, causes of poor outcome, and cost-effectiveness. Safety outcomes were transfusion reactions, thromboembolic complications, and serious adverse events occurring during hospitalisation. This statistical analysis plan was written without knowledge of the unblinded data. TRIAL REGISTRATION The trial was registered with the Netherlands Trial Register on 29 April 2008 ( NTR1303 ).
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9.
Platelet transfusion versus standard care after acute stroke due to spontaneous cerebral haemorrhage associated with antiplatelet therapy (PATCH): a randomised, open-label, phase 3 trial
Baharoglu MI, Cordonnier C, Salman RA, de Gans K, Koopman MM, Brand A, Majoie CB, Beenen LF, Marquering HA, Vermeulen M, et al
Lancet (London, England). 2016;387((10038):):2605-2613. 2605
Abstract
BACKGROUND Platelet transfusion after acute spontaneous primary intracerebral haemorrhage in people taking antiplatelet therapy might reduce death or dependence by reducing the extent of the haemorrhage. We aimed to investigate whether platelet transfusion with standard care, compared with standard care alone, reduced death or dependence after intracerebral haemorrhage associated with antiplatelet therapy use. METHODS We did this multicentre, open-label, masked-endpoint, randomised trial at 60 hospitals in the Netherlands, UK, and France. We enrolled adults within 6 h of supratentorial intracerebral haemorrhage symptom onset if they had used antiplatelet therapy for at least 7 days beforehand and had a Glasgow Coma Scale score of at least 8. With use of a secure web-based system that concealed allocation and used biased coin randomisation, study collaborators randomly assigned participants (1:1; stratified by hospital and type of antiplatelet therapy) to receive either standard care or standard care with platelet transfusion within 90 min of diagnostic brain imaging. Participants and local investigators giving interventions were not masked to treatment allocation, but allocation was concealed from outcome assessors and investigators analysing data. The primary outcome was shift towards death or dependence rated on the modified Rankin Scale (mRS) at 3 months, and analysed by ordinal logistic regression, adjusted for stratification variables and the Intracerebral Haemorrhage Score. The primary analysis was done in the intention-to-treat population and safety analyses were done in the intention-to-treat and as-treated populations. This trial is registered with the Netherlands Trial Register, number NTR1303, and is now closed. FINDINGS Between Feb 4, 2009, and Oct 8, 2015, 41 sites enrolled 190 participants. 97 participants were randomly assigned to platelet transfusion and 93 to standard care. The odds of death or dependence at 3 months were higher in the platelet transfusion group than in the standard care group (adjusted common odds ratio 2.05, 95% CI 1.18-3.56; p=0.0114). 40 (42%) participants who received platelet transfusion had a serious adverse event during their hospital stay, as did 28 (29%) who received standard care. 23 (24%) participants assigned to platelet transfusion and 16 (17%) assigned to standard care died during hospital stay. INTERPRETATION Platelet transfusion seems inferior to standard care for people taking antiplatelet therapy before intracerebral haemorrhage. Platelet transfusion cannot be recommended for this indication in clinical practice. FUNDING The Netherlands Organisation for Health Research and Development, Sanquin Blood Supply, Chest Heart and Stroke Scotland, French Ministry of Health.
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10.
Platelet transfusion in cerebral haemorrhage (PATCH): a randomised controlled trial
Koopman M, Baharoglu I, Cordonnier C, Al-Shahi Salman R, de Gans K, Brand A, Majoie C, Beenen L, Marquering H, Vermeulen M, et al
Haematologica. 2016;101((s1)):339-340.. lb2234.