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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]).
2.
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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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.