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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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Platelet transfusion for spontaneous intracerebral hemorrhage with prior antiplatelet: A systematic review and meta-analysis
Lin, Y., Liu, Y., Liu, L., Zhang, L., Lin, Y., Yu, J., Yang, J.
Medicine. 2023;102(46):e36072
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Abstract
BACKGROUND Recent studies have highlighted the unfavorable prognosis of patients with spontaneous intracerebral hemorrhage (ICH) who have received prior antiplatelet therapy (PAP). Platelet infusion therapy (PIT) is commonly administered to such patients at many medical institutions, but its efficacy remains a subject of debate. METHODS To address this uncertainty, we conducted a comprehensive search of PubMed, EMBASE, and Cochrane Library databases for eligible studies published before June 30, 2023. Our primary outcomes of interest were favorable functional outcome and mortality, while secondary outcomes included the incidence of hematoma expansion and adverse events associated with PIT. Meta-analysis was performed using Review Manager 5.3. RESULTS Our analysis included 1 randomized controlled trial (RCT) and 6 retrospective studies, involving a total of 577 patients. Pooled analysis revealed that PIT did not contribute to a better favorable functional outcome at the 3-month follow-up (OR = 0.49, 95% CI 0.27-0.89) among ICH patients with PAP. Furthermore, PIT did not significantly reduce the risk of mortality (OR = 0.79, 95% CI 0.40-1.55) or hematoma expansion (OR = 1.15, 95% CI 0.65-2.01). Notably, no significant differences in serious adverse events were observed between patients who underwent PIT and those who did not. CONCLUSIONS Based on the available evidence, there is no indication that PIT can enhance the prognosis of spontaneous ICH patients with prior antiplatelet therapy, although this treatment approach appears to be safe. Therefore, routine recommendation of PIT for ICH patients with prior antiplatelet therapy is not warranted.
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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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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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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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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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Effectiveness of platelet transfusion in dengue fever: a randomized controlled trial
Khan Assir MZ, Kamran U, Ahmad HI, Bashir S, Mansoor H, Anees SB, Akram J
Transfusion Medicine & Hemotherapy. 2013;40((5):):362-8.
Abstract
BACKGROUND Scientific data regarding effects of platelet transfusion on platelet count in dengue-related thrombocytopenia is scanty. METHODS A single center, randomized non-blinded trial was conducted on adult patients with dengue fever and platelet counts less than 30,000/mul. Patients were randomized to treatment and control group. Treatment group received single donor platelets. Patients with post-transfusion platelet increment (PPI) >=10,000/mul and/or corrected count increment (CCI) >=5,000/mul 1 h post-transfusion were considered responders. Primary outcome was platelet count increments at 24 and 72 h. RESULTS 87 patients were enrolled, and 43 (48.2%) received platelet transfusion. Mean PPI and CCI at 1 h post-transfusion in the treatment group were 18,800/mul and 7,000/mul respectively. 22 (53.6%) patients in the treatment group were non-responders. Mean platelet increments at 24 and 72 h were higher in the treatment group as compared to the control group. Responders showed significantly higher increments when compared to non-responders and the control group at 24 h (p = 0.004 and p <= 0.001, respectively) and 72 h (p = 0.001 and p <= 0.001, respectively). Significant differences were found between non-responders and the control group at 24 h (p <= 0.001), but not at 72 h (p = 0.104). Patients with lower baseline platelet count were more likely to be non-responders. Platelet transfusion neither prevented development of severe bleeding nor shortened time to cessation of bleeding. Three severe transfusion reactions and two deaths occurred in treatment group. CONCLUSION In this trial, almost half the patients showed no response to a high-dose platelet transfusion. Platelet transfusion did not prevent development of severe bleeding or shorten time to cessation of bleeding and was associated with significant side effects. Therefore, platelet transfusion should not be routinely done in the management of dengue fever.
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Allogenic platelet gel in the treatment of pressure sores: a pilot study
Scevola S, Nicoletti G, Brenta F, Isernia P, Maestri M, Faga A
International Wound Journal. 2010;7((3):):184-90.
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Abstract
Although platelet gel is considered one of the most popular tools in the treatment of chronic ulcers, current consensus on its use is not unanimous. A prospective randomised trial was carried out at the Plastic Surgery Unit of the 'Salvatore Maugeri' Foundation Hospital of Pavia (Italy). The study involved 13 patients affected by spinal cord injury with 16 pressure sores over a period of 20 months. The ulcer was considered the experimental unit of the study irrespective of the number of ulcers per patient. Each consecutive ulcer was randomised to be treated either with allogenic platelet gel or with current best practice approach to chronic wounds dressing protocol. At the end of the treatment 15 ulcers out of 16 improved clinically. No statistically significant difference was demonstrated in volume reduction between the two groups, although a statistically significant difference could be demonstrated in the onset time of granulation tissue proliferation as in the wounds treated with platelet gel the healing process was triggered earlier. Our study suggests that platelet gel is mostly effective within the first 2 weeks of treatment while a prolonged treatment does not provide any significant advantage versus the current best practice approach to chronic wounds protocols.
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PATCH: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial
de Gans K, de Haan RJ, Majoie CB, Koopman MM, Brand A, Dijkgraaf MG, Vermeulen M, Roos YB, PATCH Investigators
BMC Neurology. 2010;10:19
Abstract
BACKGROUND Patients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients who are on antiplatelet therapy have been shown to be particularly at risk of early haematoma growth, platelet transfusion may have a beneficial effect. METHODS/DESIGN The primary objective is to investigate whether platelet transfusion improves outcome in intracerebral haemorrhage patients who are on antiplatelet treatment. The PATCH study is a prospective, randomised, multi-centre study with open treatment and blind endpoint evaluation. Patients will be randomised to receive platelet transfusion within six hours or standard care. The primary endpoint is functional health after three months. The main secondary endpoints are safety of platelet transfusion and the occurrence of haematoma growth. To detect an absolute poor outcome reduction of 20%, a total of 190 patients will be included. DISCUSSION To our knowledge this is the first randomised controlled trial of platelet transfusion for an acute haemorrhagic disease.