INTRODUCTION: Neonatal thrombocytopenia is a common and important clinical problem in preterm neonates. A trial assessing clinically relevant outcomes in relation to the different platelet count thresholds used to trigger transfusion has never been undertaken in preterm neonates with severe thrombocytopenia. OBJECTIVES: Platelets for Neonatal Transfusion - Study 2 (PlaNeT-2) aims to assess whether a higher prophylactic platelet transfusion threshold is superior to the lower thresholds in current standard practice in reducing the proportion of patients who have a major bleed or die up to study day 28. METHODS: PlaNeT-2 is a two-stage, randomised, parallel-group, superiority trial. PlaNet-2 compares clinical outcomes in preterm neonates (<34 weeks' gestation at birth) randomised to receive prophylactic platelet transfusions to maintain platelet counts at or above either 25 × 10(9)/l or 50 × 10(9)/l. The primary outcome measure is the proportion of patients who either die or experience a major bleed up to and including study day 28. A total of 660 infants will be randomised. RESULTS AND CONCLUSIONS: This trial will help define optimal platelet transfusion support for severely thrombocytopenic preterm neonates by evaluating the risks and benefits of two different prophylactic neonatal platelet transfusion thresholds.
INTRODUCTION: Neonatal thrombocytopenia is a common and important clinical problem in preterm neonates. A trial assessing clinically relevant outcomes in relation to the different platelet count thresholds used to trigger transfusion has never been undertaken in preterm neonates with severe thrombocytopenia. OBJECTIVES: Platelets for Neonatal Transfusion - Study 2 (PlaNeT-2) aims to assess whether a higher prophylactic platelet transfusion threshold is superior to the lower thresholds in current standard practice in reducing the proportion of patients who have a major bleed or die up to study day 28. METHODS: PlaNeT-2 is a two-stage, randomised, parallel-group, superiority trial. PlaNet-2 compares clinical outcomes in preterm neonates (<34 weeks' gestation at birth) randomised to receive prophylactic platelet transfusions to maintain platelet counts at or above either 25 × 10(9)/l or 50 × 10(9)/l. The primary outcome measure is the proportion of patients who either die or experience a major bleed up to and including study day 28. A total of 660 infants will be randomised. RESULTS AND CONCLUSIONS: This trial will help define optimal platelet transfusion support for severely thrombocytopenic preterm neonates by evaluating the risks and benefits of two different prophylactic neonatal platelet transfusion thresholds.
Authors: Susanna F Fustolo-Gunnink; Karin Fijnvandraat; David van Klaveren; Simon J Stanworth; Anna Curley; Wes Onland; Ewout W Steyerberg; Ellen de Kort; Esther J d'Haens; Christian V Hulzebos; Elise J Huisman; Willem P de Boode; Enrico Lopriore; Johanna G van der Bom Journal: Blood Date: 2019-12-26 Impact factor: 22.113
Authors: Marianne E Nellis; Arun Saini; Philip C Spinella; Peter J Davis; Marie E Steiner; Marisa Tucci; Melissa Cushing; Pierre Demaret; Simon J Stanworth; Stephane Leteurtre; Oliver Karam Journal: Pediatr Crit Care Med Date: 2020-03 Impact factor: 3.624
Authors: Jeanine J Sol; Moniek van de Loo; Marit Boerma; Klasien A Bergman; Albertine E Donker; Mark A H B M van der Hoeven; Christiaan V Hulzebos; Ronny Knol; K Djien Liem; Richard A van Lingen; Enrico Lopriore; Monique H Suijker; Daniel C Vijlbrief; Remco Visser; Margreet A Veening; Mirjam M van Weissenbruch; C Heleen van Ommen Journal: BMC Pediatr Date: 2018-02-23 Impact factor: 2.125