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Therapeutic efficacy and safety of pathogen-reduced platelet components: Results of a meta-analysis of randomized controlled trials
Cid, J., Charry, P., Lozano, M.
Vox sanguinis. 2024
Abstract
BACKGROUND AND OBJECTIVES Clinical efficacy and safety of pathogen-reduced platelet concentrates (PR-PCs) concerning bleeding prevention are still debated despite conclusive real-world data from multiple countries where PR-PCs are transfused routinely. We performed a meta-analysis of randomized controlled trials (RCTs) comparing the clinical efficacy and safety of conventional platelet components (PCs) and PR-PCs prepared with the amotosalen/ultraviolet A light (INTERCEPT platelet concentrate [I-PC]) or riboflavin/ultraviolet light (Mirasol platelet concentrate [M-PC]) technologies, transfused in thrombocytopenic adult patients. MATERIALS AND METHODS A literature search was conducted, and 10 RCTs met the criteria for inclusion in this meta-analysis. Summary odds ratios (ORs) of clinically significant bleeding (World Health Organization [WHO] bleeding grade ≥2), severe bleeding (WHO bleeding score ≥3) and all-cause mortality were calculated. RESULTS The use of I-PC was not associated with an increase in the OR of clinically significant bleeding when compared to non-treated PCs (OR, 1.12; 95% CI: 0.89-1.41; p = 0.33), whereas transfusions with M-PC showed an increase in clinically significant bleeding (OR, 1.34; 95% CI: 1.03-1.75; p = 0.03). The OR of severe bleeding did not increase with either I-PC or M-PC (OR 0.88; 95% CI: 0.59-1.31; p = 0.52 for I-PC; OR 1.25; 95% CI: 0.66-2.37; p = 0.49 for M-PC). In the case of all-cause mortality, compared to non-treated PC, I-PC showed an OR of 0.61 (95% CI: 0.36-1.04; p = 0.07), and M-PC showed an OR of 3.04 (95% CI: 0.81-11.47; p = 0.1). CONCLUSION No differences were observed concerning the clinical efficacy and safety of overall PR-PCs when compared to non-treated PCs. However, differences are evident when analysing platelets prepared with the two PR technologies independently.
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Platelet Transfusion before CVC Placement in Patients with Thrombocytopenia
van Baarle FLF, van de Weerdt EK, van der Velden Wjfm, Ruiterkamp RA, Tuinman PR, Ypma PF, van den Bergh WM, Demandt AMP, Kerver ED, Jansen AJG, et al
The New England journal of medicine. 2023;388(21):1956-1965
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Editor's Choice
Abstract
BACKGROUND Transfusion guidelines regarding platelet-count thresholds before the placement of a central venous catheter (CVC) offer conflicting recommendations because of a lack of good-quality evidence. The routine use of ultrasound guidance has decreased CVC-related bleeding complications. METHODS In a multicenter, randomized, controlled, noninferiority trial, we randomly assigned patients with severe thrombocytopenia (platelet count, 10,000 to 50,000 per cubic millimeter) who were being treated on the hematology ward or in the intensive care unit to receive either one unit of prophylactic platelet transfusion or no platelet transfusion before ultrasound-guided CVC placement. The primary outcome was catheter-related bleeding of grade 2 to 4; a key secondary outcome was grade 3 or 4 bleeding. The noninferiority margin was an upper boundary of the 90% confidence interval of 3.5 for the relative risk. RESULTS We included 373 episodes of CVC placement involving 338 patients in the per-protocol primary analysis. Catheter-related bleeding of grade 2 to 4 occurred in 9 of 188 patients (4.8%) in the transfusion group and in 22 of 185 patients (11.9%) in the no-transfusion group (relative risk, 2.45; 90% confidence interval [CI], 1.27 to 4.70). Catheter-related bleeding of grade 3 or 4 occurred in 4 of 188 patients (2.1%) in the transfusion group and in 9 of 185 patients (4.9%) in the no-transfusion group (relative risk, 2.43; 95% CI, 0.75 to 7.93). A total of 15 adverse events were observed; of these events, 13 (all grade 3 catheter-related bleeding [4 in the transfusion group and 9 in the no-transfusion group]) were categorized as serious. The net savings of withholding prophylactic platelet transfusion before CVC placement was $410 per catheter placement. CONCLUSIONS The withholding of prophylactic platelet transfusion before CVC placement in patients with a platelet count of 10,000 to 50,000 per cubic millimeter did not meet the predefined margin for noninferiority and resulted in more CVC-related bleeding events than prophylactic platelet transfusion. (Funded by ZonMw; PACER Dutch Trial Register number, NL5534.).
PICO Summary
Population
Patients with severe thrombocytopenia enrolled in the PACER randomised controlled trial (n= 338).
Intervention
Placement of a central venous catheter (CVC) with one unit of prophylactic platelet transfusion (188 placements).
Comparison
Placement of an CVC without a platelet transfusion (185 placements).
Outcome
A total of 373 episodes of CVC placement involving 338 patients were included in the per-protocol primary analysis. Catheter-related bleeding of grade 2 to 4 occurred in 9 of 188 patients (4.8%) in the transfusion group and in 22 of 185 patients (11.9%) in the no-transfusion group (relative risk, 2.45; 90% confidence interval (CI), [1.27, 4.70]). Catheter-related bleeding of grade 3 or 4 occurred in 4 of 188 patients (2.1%) in the transfusion group and in 9 of 185 patients (4.9%) in the no-transfusion group (relative risk, 2.43; 95% CI [0.75, 7.93]). There were 15 adverse events, of these events 13 (all grade 3 catheter-related bleeding [4 in the transfusion group and 9 in the no-transfusion group]) were categorized as serious. The net savings of withholding prophylactic platelet transfusion before CVC placement was $410 per catheter placement.
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Root coverage with platelet-rich fibrin or connective tissue graft: a split-mouth randomized trial
Carrera, T. M. I., Machado, L. M., Soares, M. T. R., Passos, G. P., Oliveira, G. J. P., Ribeiro Júnior, N. V., Soares, P. B. F., Pigossi, S. C.
Brazilian oral research. 2023;37:e084
Abstract
This study aimed to compare the use of connective tissue grafts (CTG) and platelet-rich fibrin (PRF) associated with the tunnel technique (TT) for the treatment of multiple gingival recessions (GR). Fourteen patients with multiple bilateral GR [type 1 recession (RT 1)] in the maxillary incisors, canines, and/or premolars were included. The TT was performed on both sides (split-mouth model); CTG (36 GR) was used on one side, and on the other, PRF (36 GR) was used. Clinical parameters, including recession depth (RD), probing depth, clinical attachment level (CAL), and keratinized gingiva thickness/width (GT/KTW), were obtained at baseline and after 1, 3, 6, and 16 months. Lower RD (0.81 ± 0.68 vs. 1.23 ± 0.71 mm) and CAL (2.54 ± 0.63 vs. 2.73 ± 0.82 mm) were observed for CTG compared to PRF after 16 months. Higher GT was obtained for CTG compared to PRF after 3 (1.81 ± 0.56 vs 1.43 ± 0.47 mm) and 6 months (1.67 ± 0.61 vs. 1.38 ± 0.55 mm, p < 0.05). The recession coverage (RC) was higher for CTG (55.42% ± 37.14) in comparison to PRF (29.53% ± 34.08) after 16 months (p < 0.05). Similarly, CTG presented a more complete coverage of the recession (15; 41.66%) than PRF (9; 24.32%). There were no significant differences between the groups in terms of surgery time, postoperative pain, or healing patterns. Greater esthetic satisfaction was obtained with CTG. It was concluded that CTG combined with TT showed clinical and esthetic results superior to those of PRF in multiple GR treatments.
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Clinical evaluation of the combined efficacy of injectable platelet-rich fibrin along with scaling and root planing in the non-surgical periodontal therapy of stage III and grade C periodontitis patients having type 2 diabetes mellitus: A randomized controlled trial
Shunmuga, P. D., Tadepalli, A., Parthasarathy, H., Ponnaiyan, D., Cholan, P. K., Ramachandran, L.
Clinical advances in periodontics. 2023
Abstract
BACKGROUND This randomized controlled trial was aimed to evaluate the combined efficacy of injectable platelet-rich fibrin (i-PRF) and scaling and root planing (SRP) in type 2 diabetes mellitus subjects having periodontitis. METHODS Twenty-six Stage III, grade C periodontitis subjects (HbA1c > 7) were recruited in this split-mouth study. Following SRP, the test sites received subgingival application of i-PRF, while the control sites received saline. Plaque index, bleeding on probing, modified gingival index, probing pocket depth (PPD) and clinical attachment level (CAL) were measured at baseline, 3 and 6 months. RESULTS Twenty-three participants completed the course of research. The Friedman test followed by Dunn's post hoc test, revealed significant improvement in all the clinical parameters from baseline to 3 and 6 months in both the study groups (p ≤ 0.05). The mean PPD and CAL decreased from 6.30 ± 1.25 and 7.48 ± 1.75 at baseline to 3.48 ± 1.34 and 4.39 ± 1.67 at 6 months in control sites and from 6.57 ± 1.56 and 7.61 ± 1.69 to 3.39 ± 1.23 and 4.26 ± 1.81 at 6 months in test sites (p ≤ 0.0001). Intergroup analysis found no statistical significant differences in the evaluated parameters across all time intervals (p > 0.05) CONCLUSION The results indicated that the adjunctive application of i-PRF to SRP provided similar benefits as saline and SRP in diabetes mellitus subjects. KEY POINTS Question: To find the combined efficacy of injectable platelet-rich fibrin (i-PRF) along with scaling and root planing (SRP) in the management of periodontal pockets of Stage III and Grade C periodontitis patients having Type 2 Diabetes Mellitus (T2DM). FINDING All of the treated sites showed satisfactory healing. Both the treatment modalities (i-PRF + SRP and Saline + SRP) were effective in the treatment of periodontal pockets. At 3 and 6 months, there were no significant differences in periodontal parameters between groups. Meaning: The application of i-PRF as an adjunct to SRP provided similar benefits as saline and SRP in improving clinical parameters in subjects with stage III and grade C periodontitis patients having T2DM (HbA1C > 7).
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Two-year outcomes following a randomised platelet transfusion trial in preterm infants
Moore CM, D'Amore A, Fustolo-Gunnink S, Hudson C, Newton A, Santamaria BL, Deary A, Hodge R, Hopkins V, Mora A, et al
Archives of disease in childhood. Fetal and neonatal edition. 2023
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Free full text
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Editor's Choice
Abstract
OBJECTIVE Assess mortality and neurodevelopmental outcomes at 2 years of corrected age in children who participated in the PlaNeT-2/MATISSE (Platelets for Neonatal Transfusion - 2/Management of Thrombocytopenia in Special Subgroup) study, which reported that a higher platelet transfusion threshold was associated with significantly increased mortality or major bleeding compared to a lower one. DESIGN Randomised clinical trial, enrolling from June 2011 to August 2017. Follow-up was complete by January 2020. Caregivers were not blinded; however, outcome assessors were blinded to treatment group. SETTING 43 level II/III/IV neonatal intensive care units (NICUs) across UK, Netherlands and Ireland. PATIENTS 660 infants born at less than 34 weeks' gestation with platelet counts less than 50×10(9)/L. INTERVENTIONS Infants were randomised to undergo a platelet transfusion at platelet count thresholds of 50×10(9)/L (higher threshold group) or 25×10(9)/L (lower threshold group). MAIN OUTCOMES MEASURES Our prespecified long-term follow-up outcome was a composite of death or neurodevelopmental impairment (developmental delay, cerebral palsy, seizure disorder, profound hearing or vision loss) at 2 years of corrected age. RESULTS Follow-up data were available for 601 of 653 (92%) eligible participants. Of the 296 infants assigned to the higher threshold group, 147 (50%) died or survived with neurodevelopmental impairment, as compared with 120 (39%) of 305 infants assigned to the lower threshold group (OR 1.54, 95% CI 1.09 to 2.17, p=0.017). CONCLUSIONS Infants randomised to a higher platelet transfusion threshold of 50×10(9)/L compared with 25×10(9)/L had a higher rate of death or significant neurodevelopmental impairment at a corrected age of 2 years. This further supports evidence of harm caused by high prophylactic platelet transfusion thresholds in preterm infants. TRIAL REGISTRATION NUMBER ISRCTN87736839.
PICO Summary
Population
Preterm infants enrolled in the PlaNeT-2/MATISSE trial, at 43 neonatal intensive care units across UK, Netherlands and Ireland (n= 660).
Intervention
Higher platelet transfusion threshold (n= 296).
Comparison
Lower platelet transfusion threshold (n= 305).
Outcome
The prespecified long-term follow-up outcome was a composite of death or neurodevelopmental impairment (developmental delay, cerebral palsy, seizure disorder, profound hearing or vision loss) at 2 years of corrected age. Follow-up data were available for 601 of 653 (92%) eligible participants. Of the 296 infants assigned to the higher threshold group, 147 (50%) died or survived with neurodevelopmental impairment, as compared with 120 (39%) of 305 infants assigned to the lower threshold group (OR: 1.54; 95% CI [1.09, 2.17]).
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Risk of HLA antibody generation after receipt of Mirasol versus standard platelets in the MIPLATE randomized trial
Kaidarova Z, Di Germanio C, Custer B, Norris PJ
Transfusion. 2023
Abstract
BACKGROUND Human leukocyte antigen (HLA) alloimmunization can occur after platelet transfusion. These antibodies can complicate future platelet transfusions or organ transplantation. Animal data suggest that Mirasol pathogen reduction treatment (PRT) can prevent alloimmunization after transfusion. STUDY DESIGN AND METHODS The MIPLATE trial enrolled 330 of a planned 660 participants with hematological malignancies at risk for grade 2 or greater bleeding. The study was halted early for futility after a planned interim analysis. Participants were randomized to receive PRT versus standard control platelets. Serum samples were collected from participants at baseline (pretransfusion), weekly for the first 4 weeks, then at days 42 and 56. HLA antibody levels were determined using a commercial multianalyte bead-based assay. HLA antibody levels were analyzed using low, medium, and high cutoffs based on prior studies. RESULTS The rate of alloimmunization was low in both arms of the study, particularly at the high HLA antibody cutoff (total of 6 of 277 subjects at risk, or 2.2%). The risk of alloimmunization did not differ between study arms, nor did the risk of immune refractoriness to platelet transfusion. CONCLUSIONS The data do not support the conclusion that Mirasol exerted a protective effect against alloimmunization after platelet transfusion in the MIPLATE trial.
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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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A meta-analysis of risk factors associated with platelet transfusion refractoriness
Song X, Qi J, Fang K, Li X, Han Y
International journal of hematology. 2023
Abstract
BACKGROUND Platelet transfusion refractoriness (PTR) remains an intractable issue in clinical practice, and is common in hematological patients. At present, it is believed that both immune and non-immune factors play a role. We conducted a meta-analysis of various risk factors which may contribute to PTR. METHODS PubMed, Embase, Cochrane library, and Web of Science were selected as research database platforms. Citations included were further assessed for quality and bias using the Newcastle-Ottawa Scale. All analyses were performed using Review Manager Version 5.4 and STATA 16.0. RESULTS The preliminary search revealed 1069 publications, and 17 (5929 patients in total) were ultimately included in the quantitative analysis. The following variables were associated with the occurrence of PTR: fever (OR = 2.26, 95%CI 2.00-2.55, p < 0.00001), bleeding (OR = 2.10, 95%CI 1.36-3.24, p = 0.0008), female sex (OR = 2.06, 95%CI 1.13-3.75, p = 0.02), antibiotic use (OR = 2.94, 95%CI 1.54-5.59, p = 0.001), and infection (OR = 2.19, 95%CI 1.20-4.03, p = 0.01). Antibodies involved in immune activation were a higher risk factor (OR = 4.17, 95%CI 2.36-7.36, p < 0.00001), and splenomegaly was nearly significant (OR = 1.73, 95%CI 0.97-3.07, p = 0.06). CONCLUSIONS We identified some important risk factors for PTR, but further research is needed to identify the many other possible elements that may contribute to or mediate PTR.
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Comparison between platelet rich fibrin as space filling material versus xenograft and alloplastic bone grafting materials in immediate implant placement: a randomized clinical trial
Elsheikh, H. A., Abdelsameaa, S. E., Elbahnasi, A. A., Abdel-Rahman, F. H.
BMC oral health. 2023;23(1):977
Abstract
BACKGROUND This study aimed to compare the efficacy of different gap filling materials in immediate implant in anterior and premolar regions of maxilla. MATERIALS AND METHODS Thirty-six implants were inserted in patients seeking for replacement of non-restorable maxillary anterior and premolar teeth (esthetic zone) by immediate implant. Patients were randomly distributed into three equal groups, twelve implants in each group. Group 1 received Platelet Rich Fibrin (PRF) into the jumping distance, Group 2 received Xenograft into the jumping distance and Group 3 received Alloplastic bone grafting material into the jumping distance. Implant stability by measuring the changes in Resonance Frequency Analysis (RFA), peri-implant pocket depth, marginal bone loss and changes in buccal bone thickness were evaluated during follow up periods. All the clinical and radiographic data were subjected to statistical analysis by One Way ANOVA test and the Post Hoc Tukey test. RESULTS This study involved 19 female patients and 17 male patients who received 36 dental implants. There was no significant difference between the study groups regarding implant stability, peri-implant pocket depth and palatal bone loss, while there was a significant difference between PRF Group (Group 1) and the other Groups regarding buccal bone loss and changes in buccal bone thickness. CONCLUSION PRF can be used as a gap filling material in conjunction with immediate implant placement, but other bone grafting materials give superior result regarding buccal bone loss and changes in buccal bone thickness. TRIAL REGISTRATION The study was listed on www. CLINICALTRIALS gov with registration number (NCT05878392) on 26/05/2023. The Institutional Review Board (IRB) of the Faculty of Dentistry, Mansoura University, Mansoura, Egypt, approved the current study in compliance with the seventh revision of the Helsinki Declaration in 2013 (A0103023OS).
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Platelet transfusions in preterm infants: current concepts and controversies-a systematic review and meta-analysis
Ribeiro HS, Assunção A, Vieira RJ, Soares P, Guimarães H, Flor-de-Lima F
European journal of pediatrics. 2023
Abstract
Platelet transfusions (PTx) are the principal approach for treating neonatal thrombocytopenia, a common hematological abnormality affecting neonates, particularly preterm infants. However, evidence about the outcomes associated with PTx and whether they provide clinical benefit or harm is lacking. The aim of this systematic review and meta-analysis is to assess the association between PTx in preterm infants and mortality, major bleeding, sepsis, and necrotizing enterocolitis (NEC) in comparison to not transfusing or using different platelet count thresholds for transfusion. A broad electronic search in three databases was performed in December 2022. We included randomized controlled trials, and cohort and case control studies of preterm infants with thrombocytopenia that (i) compared treatment with platelet transfusion vs. no platelet transfusion, (ii) assessed the platelet count threshold for PTx, or (iii) compared single to multiple PTx. We conducted a meta-analysis to assess the association between PTx and mortality, intraventricular hemorrhage (IVH), sepsis, and NEC and, in the presence of substantial heterogeneity, leave-one-out sensitivity analysis was performed. We screened 625 abstracts and 50 full texts and identified 18 reports of 13 eligible studies. The qualitative analysis of the included studies revealed controversial results as several studies showed an association between PTx in preterm infants and a higher risk of mortality, major bleeding, sepsis, and NEC, while others did not present a significant relationship. The meta-analysis results suggest a significant association between PTx and mortality (RR 2.4, 95% CI 1.8-3.4; p < 0.0001), as well as sepsis (RR 4.5, 95% CI 3.7-5.6; p < 0.0001), after a leave-one-out sensitivity analysis. There was also found a significant correlation between PTx and NEC (RR 5.2, 95% CI 3.3-8.3; p < 0.0001). As we were not able to reduce heterogeneity in the assessment of the relationship between PTx and IVH, no conclusion could be taken. Conclusion: Platelet transfusions in preterm infants are associated to a higher risk of death, sepsis, and NEC and, possibly, to a higher incidence of IVH. Further studies are needed to confirm these associations, namely between PTx and IVH, and to define the threshold from which PTx should be given with less harm effect. What is Known: • Platelet transfusions are given to preterm infants with thrombocytopenia either to treat bleeding or to prevent hemorrhage. • Lack of consensual criteria for transfusion. What is New: • A significant association between platelet transfusions and mortality, sepsis, and NEC.