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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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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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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.
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Effect of platelet storage duration on clinical outcomes and incremental platelet change in critically ill children
Nellis, M. E., Spinella, P. C., Tucci, M., Stanworth, S. J., Steiner, M. E., Cushing, M. M., Davis, P. J., Karam, O.
Transfusion. 2020;60(12):2849-2858
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Abstract
The safety of platelet (PLT) concentrates with longer storage duration has been questioned due to biochemical and functional changes that occur during blood collection and storage. Some studies have suggested that transfusion efficacy is decreased and immune system dysfunction is worsened with increased storage age. We sought to describe the effect of PLT storage age on laboratory and clinical outcomes in critically ill children receiving PLT transfusions. STUDY DESIGN AND METHODS We performed a secondary analysis of a prospective, observational point-prevalence study. Children (3 days to 16 years of age) from 82 pediatric intensive care units in 16 countries were enrolled if they received a PLT transfusion during one of the predefined screening weeks. Outcomes (including PLT count increments, organ dysfunction, and transfusion reactions) were evaluated by PLT storage age. RESULTS Data from 497 patients were analyzed. The age of the PLT transfusions ranged from 1 to 7 days but the majority were 4 (24%) or 5 (36%) days of age. Nearly two-thirds of PLT concentrates were transfused to prevent bleeding. The indication for transfusion did not differ between storage age groups (P = .610). After patient and product variables were adjusted for, there was no association between storage age and incremental change in total PLT count or organ dysfunction scoring. A significant association between fresher storage age and febrile transfusion reactions (P = .002) was observed. CONCLUSION The results in a large, diverse cohort of critically ill children raise questions about the impact of storage age on transfusion and clinical outcomes which require further prospective evaluation.
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Platelet transfusion thresholds in premature neonates (PlaNeT-2 trial)
Estcourt LJ
Transfusion Medicine. 2019;29(1):20-22
Abstract
CLINICAL QUESTION Does transfusing platelets to preterm infants (< 34 weeks) at a higher platelet count threshold count (< 50 x 109 /L) reduce the risk of major bleeding or death compared to only transfusing platelets when the platelet count drops below 25 x 109 /L. EVIDENCE FROM TRIAL Preterm infants with a low platelet count who were transfused platelets at the higher platelet count threshold had a higher risk of dying or having a major bleed than those who were not. The reasons why this occurred are currently unclear. Copyright © 2019 British Blood Transfusion Society.
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Randomized Trial of Platelet-Transfusion Thresholds in Neonates
Curley A, Stanworth SJ, Willoughby K, Fustolo-Gunnink SF, Venkatesh V, Hudson C, Deary A, Hodge R, Hopkins V, Lopez Santamaria B, et al
The New England Journal of Medicine. 2019;380:242-251
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Editor's Choice
Abstract
BACKGROUND Platelet transfusions are commonly used to prevent bleeding in preterm infants with thrombocytopenia. Data are lacking to provide guidance regarding thresholds for prophylactic platelet transfusions in preterm neonates with severe thrombocytopenia. METHODS In this multicenter trial, we randomly assigned infants born at less than 34 weeks of gestation in whom severe thrombocytopenia developed to receive a platelet transfusion at platelet-count thresholds of 50,000 per cubic millimeter (high-threshold group) or 25,000 per cubic millimeter (low-threshold group). Bleeding was documented prospectively with the use of a validated bleeding-assessment tool. The primary outcome was death or new major bleeding within 28 days after randomization. RESULTS A total of 660 infants (median birth weight, 740 g; and median gestational age, 26.6 weeks) underwent randomization. In the high-threshold group, 90% of the infants (296 of 328 infants) received at least one platelet transfusion, as compared with 53% (177 of 331 infants) in the low-threshold group. A new major bleeding episode or death occurred in 26% of the infants (85 of 324) in the high-threshold group and in 19% (61 of 329) in the low-threshold group (odds ratio, 1.57; 95% confidence interval [CI], 1.06 to 2.32; P=0.02). There was no significant difference between the groups with respect to rates of serious adverse events (25% in the high-threshold group and 22% in the low-threshold group; odds ratio, 1.14; 95% CI, 0.78 to 1.67). CONCLUSIONS Among preterm infants with severe thrombocytopenia, those randomly assigned to receive platelet transfusions at a platelet-count threshold of less than 50,000 per cubic millimeter had a significantly higher rate of death or major bleeding within 28 days after randomization than those in the group that received less than 25,000 per cubic millimeter. (Funded by the National Health Service Blood and Transplant Research and Development Committee and others; Current Controlled Trials number, ISRCTN87736839 .).
PICO Summary
Population
Infants born at less than 34 weeks of gestation in whom severe thrombocytopenia developed, from centres in Ireland, The Netherlands and UK (n= 660).
Intervention
platelet-count thresholds of 50,000 per cubic millimeter (high-threshold group, n= 328).
Comparison
25,000 per cubic millimeter (low-threshold group, n= 331).
Outcome
In the high-threshold group, 90% of the infants (296 of 328 infants) received at least one platelet transfusion, as compared with 53% (177 of 331 infants) in the low-threshold group. A new major bleeding episode or death occurred in 26% of the infants (85 of 324) in the high-threshold group and in 19% (61 of 329) in the low-threshold group (odds ratio, 1.57; 95% confidence interval [CI], 1.06 to 2.32). There was no significant difference between the groups with respect to rates of serious adverse events (25% in the high-threshold group and 22% in the low-threshold group; odds ratio, 1.14; 95% CI, 0.78 to 1.67).
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Are thrombocytopenia and platelet transfusions associated with major bleeding in preterm neonates? A systematic review
Fustolo-Gunnink SF, Huijssen-Huisman EJ, van der Bom JG, van Hout FMA, Makineli S, Lopriore E, Fijnvandraat K
Blood Reviews. 2018
Abstract
Over 75% of severely thrombocytopenic preterm neonates receive platelet transfusions to prevent bleeding, but transfusion guidelines are based mainly on expert opinion. The aim of this review was to investigate whether platelet counts or transfusions are associated with major bleeding in preterm neonates. We performed a systematic search of the EMBASE and MEDLINE databases until December 2017. We included randomized trials, cohort and case control studies. (Prospero: CRD42015013399). We screened 8734 abstracts and 1225 fulltexts, identifying 36 eligible studies. In 30, timing of the platelet counts or transfusions in relation to the bleeding was unclear. Of the remaining six studies, two showed that thrombocytopenia was associated with increased risk of bleeding, two showed no such assocation, and three showed lack of an association between platelet transfusions and bleeding risk. The study results suggest that prophylactic platelet transfusions may not reduce bleeding risk in preterm neonates.
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Platelet mass index: is it a hope for reduction of platelet transfusion in NICU?
Yavuzcan Ozturk D, Ercin S, Gursoy T, Karatekin G, Ovali F
Journal of Maternal-Fetal & Neonatal Medicine. 2016;29((12)):1926-9.
Abstract
OBJECTIVE Thrombocytopenia is a very common problem in neonatal intensive care unit whose only specific treatment is platelet (PLT) transfusion which has well-known risks. Our aim is to test whether using PLT mass-based transfusion guideline would result in fewer transfusions or not. METHODS One hundred neonates with PLT count <100000/mul were randomized into two groups: Group 1 (n=50) was transfused according to PLT count-based guideline, whereas Group 2 (n=50) was transfused according to PLT mass-based guideline. Subjects receiving one or more PLT transfusions and total number of PLT transfusions, hemorrhages, morbidity and mortality in both groups were recorded. RESULTS Demographic characteristics, PLT counts of the infants and clinical conditions associated with thrombocytopenia in both groups were not different. There was no reduction in the number of subjects receiving PLT transfusions (54% in Group 1, 50% in Group 2; p=0.69) and in the number of PLT transfusions per infant (0.82+/-1.13 versus 0.8+/-1.23; p=0.95). There was also no difference with respect to bleeding, morbidity and mortality between the groups. CONCLUSION Transfusion according to PLT mass or PLT count-based guideline does not seem to influence number of transfusions or the number of infants who were transfused.
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Transfusing neonates based on platelet count vs. platelet mass: A randomized feasibility-pilot study
Zisk JL, Mackley A, Clearly G, Chang E, Christensen RD, Paul DA
Platelets. 2014;25((7):):513-6.
Abstract
Abstract The objective of this study was to obtain pilot data on which to judge the feasibility and sample size needed for a future comparative-effectiveness trial of platelet transfusions in the NICU. We conducted a limited-scope pilot trial in which neonates were randomized to receive platelet transfusions based on platelet mass vs. platelet count, using preset "transfusion-trigger" values. Analysis included parental consent rate, number of platelet transfusions given, bleeding episodes recorded, and mortality rate. Statistical analysis included ANOVA and Chi-square. A convenience sample of 30 were randomized; 15 per group. No differences were found between groups in gestational age, birth weight, race, gender or clinical diagnoses. The study consent rate was 52% (30/58). No differences were found in number of platelet transfusions received, bleeding episodes, or mortality. Lack of a trend in transfusion-reduction resulted in inability to estimate the number needed in a future comparative-effectiveness trial. Using platelet mass, rather than platelet count, for a NICU platelet transfusion trigger is feasible. However, any future comparative-effectiveness trial, testing the hypothesis that a platelet mass-based trigger reduces the transfusion rate will likely require a very large sample size.
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A randomized trial of platelet transfusions over 30 vs 120 minutes: is there an effect on post-transfusion platelet counts?
Dannaway DC, Noori S
Journal of Perinatology. 2013;33((9):):703-6.
Abstract
Objective:To determine whether platelet infusion time affects platelet counts in thrombocytopenic newborns. Study Design:This was a prospective randomized control study of 43 platelet transfusions given to newborns. Transfusions were randomized to run over either 30min or 2h. Platelet counts taken 30min and 6h after transfusion were compared using parametric, nonparametric, Pearson's correlation and logistic regression. Result:Changes in platelet counts 30min and 6h after transfusion were not different between the groups. Weak but significant negative correlations existed between postmenstrual age and change in platelet count at 30min (r=-0.33, P=0.04) and 6h (r=-0.37, P=0.018) after transfusion. There were no differences between the mean blood pressures before and after transfusion in either group. Conclusion:Transfusion duration does not affect post-transfusion platelet counts in newborns. Babies of lower postmenstrual age (PMA) may have better responses to platelet transfusions. Finally, platelet transfusions over both durations are well tolerated in neonates.
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Neonatal sepsis treated with buffycoat transfusions
Grunnet N, Kaad PH, Pedersen S, Pedersen JO
ISBT Congress. 1988;:134.. Abstract No. P-T-3-125.