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1Sanquin/LUMC, Center for Clinical Transfusion Research, Leiden; 2Amsterdam University Medical Center, Emma Children’s Hospital, Department of Pediatric Hematology, Amsterdam-Zuidoost; 3Sanquin Blood Supply Foundation, Department of Plasma Proteins, Sanquin Research, Amsterdam; 4Leiden University Medical Center, Department of Medical Statistics, Leiden; 5Leiden University Medical Center, Willem Alexander Children’s Hospital, Department of Neonatology, Leiden; 6Máxima Medical Center, Department of Neonatology, Veldhoven; 7Isala Zwolle, Amalia Children’s Center, Department of Neonatology, Zwolle; 8University Medical Center Groningen, Beatrix Children’s Hospital, Department of Neonatology, Groningen; 9Amsterdam University Medical Center, Emma Children’s Hospital, Department of Neonatology, Amsterdam-Zuidoost; 10Erasmus Medical Center, Sophia Children’s Hospital, Department of Neonatology, Rotterdam; 11University Medical Center Utrecht, Utrecht University, Wilhelmina Children’s Hospital, Department of Neonatology, Utrecht and 12Leiden University Medical Center, Department of Clinical Epidemiology, Leiden, the Netherlands.
Hemostasis
Ferrata Storti Foundation
Haematologica 2019 Volume 104(11):2300-2306
Dynamic prediction of bleeding risk
in thrombocytopenic preterm neonates
Susanna F. Fustolo-Gunnink,1-2 Karin Fijnvandraat,2-3 Hein Putter,4 Isabelle M. Ree,5 Camila Caram-Deelder,1 Peter Andriessen,6 Esther J. d’Haens,7 Christian V. Hulzebos,8 Wes Onland,9 André A. Kroon,10 Daniël C. Vijlbrief,11 Enrico Lopriore5 and Johanna G. van der Bom1-12
ABSTRACT
Over 75% of severely thrombocytopenic neonates receive platelet transfusions, though little evidence supports this practice, and only 10% develop major bleeding. In a recent randomized trial, giving platelet transfusions at a threshold platelet count of 50x109/L compared to a threshold of 25x109/L was associated with an increased risk of major bleeding or mortality. This finding highlights the need for improved and individualized guidelines on neonatal platelet transfusion, which require accurate prediction of bleeding risk. Therefore, the objective of this study was to develop a dynamic prediction model for major bleeding in thrombo- cytopenic preterm neonates. This model allows for calculation of bleeding risk at any time-point during the first week after the onset of severe throm- bocytopenia. In this multicenter cohort study, we included neonates with a gestational age <34 weeks, admitted to a neonatal intensive care unit, who developed severe thrombocytopenia (platelet count <50x109/L). The study endpoint was major bleeding. We obtained predictions of bleeding risk using a proportional baselines landmark supermodel. Of 640 included neonates, 71 (11%) had a major bleed. We included the variables gestational age, postnatal age, intrauterine growth retardation, necrotizing enterocoli- tis, sepsis, platelet count and mechanical ventilation in the model. The median cross-validated c-index was 0.74 (interquartile range, 0.69-0.82). This is a promising dynamic prediction model for bleeding in this popula- tion that should be explored further in clinical studies as a potential instru- ment for supporting clinical decisions. The study was registered at www.clinicaltrials.gov (NCT03110887).
Introduction
Neonatal major bleeding occurs in approximately 5-15% of preterm neonates admitted to a neonatal intensive care unit and can lead to lifelong disabilities and death. The most common type of bleeding is intraventricular hemorrhage.1,2
Since platelets are required for primary hemostasis, preterm neonates with severe thrombocytopenia are thought to be particularly at risk of major bleeding. However, the associations between thrombocytopenia, platelet transfusions and bleeding in preterm neonates are not clear. In a recently published systematic review, only six studies could be included. These provided insufficient evidence to
Correspondence:
J.G. VAN DER BOM
j.g.vanderbom@lumc.nl
Received: October 9, 2018. Accepted: February 27, 2019. Pre-published: February 28, 2019.
doi:10.3324/haematol.2018.208595
Check the online version for the most updated information on this article, online supplements, and information on authorship & disclosures: www.haematologica.org/content/104/11/2300
©2019 Ferrata Storti Foundation
Material published in Haematologica is covered by copyright. All rights are reserved to the Ferrata Storti Foundation. Use of published material is allowed under the following terms and conditions: https://creativecommons.org/licenses/by-nc/4.0/legalcode. Copies of published material are allowed for personal or inter- nal use. Sharing published material for non-commercial pur- poses is subject to the following conditions: https://creativecommons.org/licenses/by-nc/4.0/legalcode, sect. 3. Reproducing and sharing published material for com- mercial purposes is not allowed without permission in writing from the publisher.
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