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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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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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A randomized cross-over study of cryopreserved platelets in prophylactic transfusions of thrombocytopenic patients
Ang, A. L., Gan, L. S. H., Tuy, T. T., Ang, C. H., Tan, C. W., Tan, H. H., Shu, P. H., Zhang, Q., Cao, Y., Moorakonda, R. B., et al
Transfusion. 2023
Abstract
BACKGROUND The short shelf-life of liquid-stored platelets (LP) at 20-24°C poses shortage and wastage challenges. Cryopreserved platelets have significantly extended shelf-life, and were safe and efficacious for therapeutic transfusions of bleeding patients in the Afghanistan conflict and phase 2 randomized studies. Although hematology patients account for half of platelets demand, there is no randomized study on prophylactic cryopreserved platelet transfusions in them. METHODS We performed a phase 1b/2a randomized cross-over study comparing the safety and efficacy of cryopreserved buffy coat-derived pooled platelets (CP) to LP in the prophylactic transfusions of thrombocytopenic hematology patients. RESULTS A total of 18 adults were randomly assigned 1:1 to CP and LP for their first thrombocytopenic period (TP) of up to 28-days. A total of 14 crossed over to the other platelet-arm for the second TP. Overall, 17 subjects received 51 CP and 15 received 52 LP. CP-arm had more treatment emergent adverse event (29.4% vs. 13.3% of subjects, 9.8% vs. 3.8% of transfusions) than LP-arm but all were mild. No thromboembolism was observed. Both arms had similar bleeding rates (23.5% vs. 26.7% of subjects) which were all mild. Subjects in CP-arm had lower average corrected count increments than LP-arm (mean [SD] 5.6 [4.20] vs. 22.6 [9.68] ×10(9) /L at 1-4 h, p < .001; 5.3 [4.84] vs. 18.2 [9.52] ×10(9) /L at 18-30 h, p < .001). All TEG parameters at 1-4 h and maximum amplitude (MA) at 18-30 h improved from baseline post-CP transfusion (p < .05) though improvements in K-time and MA were lower than LP (p < .05). DISCUSSION During shortages, CP may supplement LP in prophylactic transfusions of thrombocytopenic patients.
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Cryopreserved platelets compared with liquid-stored platelets for the treatment of surgical bleeding: protocol for two multicentre randomised controlled blinded non-inferiority trials (the CLIP-II and CLIPNZ-II trials)
Reade, M. C., Marks, D. C., Howe, B., McGuinness, S., Parke, R., Navarra, L., Charlewood, R., Johnson, L., McQuilten, Z.
BMJ open. 2022;12(12):e068933
Abstract
INTRODUCTION Cryopreservation at -80°C in dimethylsulphoxide extends platelet shelf-life from 7 days to 2 years. Only limited comparative trial data supports the safety and effectiveness of cryopreserved platelets as a treatment for surgical bleeding. Cryopreserved platelets are not currently registered for civilian use in most countries. METHODS AND ANALYSIS CLIP-II and CLIPNZ-II are harmonised, blinded, multicentre, randomised, controlled clinical non-inferiority trials comparing bleeding, transfusion, safety and cost outcomes associated with cryopreserved platelets versus conventional liquid platelets as treatment for bleeding in cardiac surgery. CLIP-II is planning to enrol patients in 12 tertiary hospitals in Australia; CLIPNZ-II will recruit in five tertiary hospitals in New Zealand. The trials use near-identical protocols aside from details of cryopreserved platelet preparation. Patients identified preoperatively as being at high risk of requiring a platelet transfusion receive up to three units of study platelets if their treating doctor considers platelet transfusion is indicated. The primary endpoint is blood loss through the surgical drains in the 24 hours following intensive care unit (ICU) admission after surgery. Other endpoints are blood loss at other time points, potential complications, adverse reactions, transfusion and fluid requirement, requirement for procoagulant treatments, time to commencement of postoperative anticoagulants, delay between platelet order and commencement of infusion, need for reoperation, laboratory and point-of-care clotting indices, cost, length of mechanical ventilation, ICU and hospital stay, and mortality. Transfusing 202 (CLIP-II) or 228 (CLIPNZ-II) patients with study platelets will provide 90% power to exclude the possibility of greater than 20% inferiority in the primary endpoint. If cryopreserved platelets are not inferior to liquid-stored platelets, the advantages of longer shelf-life would justify rapid change in clinical practice. Cost-effectiveness analyses will be incorporated into each study such that, should clinical non-inferiority compared with standard care be demonstrated, the hospitals in each country that would benefit most from changing to a cryopreserved platelet blood bank will be known. ETHICS AND DISSEMINATION CLIP-II was approved by the Austin Health Human Research Ethics Committee (HREC/54406/Austin-2019) and by the Australian Red Cross Lifeblood Ethics Committee (2019#23). CLIPNZ-II was approved by the New Zealand Southern Health and Disability Ethics Committee (21/STH/66). Eligible patients are approached for informed consent at least 1 day prior to surgery. There is no provision for consent provided by a substitute decision-maker. The results of the two trials will be submitted separately for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBERS NCT03991481 and ACTRN12621000271808.
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The impact of pathogen-reduced platelets in acute leukaemia treatment on the total blood product requirement: a subgroup analysis of an EFFIPAP randomised trial
Garban F, Vilotitch A, Tiberghien P, Bosson JL
Transfusion medicine (Oxford, England). 2022
Abstract
OBJECTIVE To evaluate the impact of pathogen-reduced (PR) platelet transfusions on blood products requirement for clinical practice. BACKGROUND PR platelets are increasing in use as standard blood products. However, few randomised trials have evaluated their impact on bleeding control or prevention. Furthermore, PR platelets recirculate less than untreated platelets. METHODS A subgroup study of the randomised clinical trial EFFIPAP compared three arms of platelet preparations (PR: P-PRP/PAS, additive solution: P-PAS and plasma P-P arms respectively). The subgroup of acute leukaemia patients, in their chemotherapy induction phase, included 392 patients (133 P-PRP/PAS arm, 132 P-PAS arm and 130 P-P arm). Blood requirements were analysed across over periods of 7 days. RESULTS The number of platelet transfusions per week was significantly higher in the P-PRP/PAS group 2.3 [1.6-3.3] compared to the control groups 1.9 [1.3-2.8] and 2.0 [1.3-3.0] for P-P and P-PAS groups respectively (p < 0.0001). However, the total number of platelets transfused per week was not different. The number of red blood cell concentrates (RBC) transfusion per week did not differ either. CONCLUSION In a homogeneous group of patients, platelet pathogen reduction resulted in an increased number of platelet units transfused per week while having no impact on the total number of platelets transfused or the number of RBC transfusion; resulting to an average requirement of 2 RBC and 2-3 platelets transfusions per week of marrow aplasia.