Platelets for Neonatal Transfusion - Study 2: A Randomised Controlled Trial to Compare Two Different Platelet Count Thresholds for Prophylactic Platelet Transfusion to Preterm Neonates

Abstract

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 × 10⁹/l or 50 × 10⁹/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.

Thrombocytopenia and platelet transfusion in the neonate

“…The ongoing PlaNet-2 trial will provide more evidence for platelet transfusion thresholds. In this study, 660 infants with a gestational age <34 weeks will be randomized into two arms with different transfusion thresholds (25 vs 50 Â 10 9 /L) and followed up to evaluate the incidence of minor and major bleeding [55].…”

Platelet Transfusions in the Neonatal Intensive Care Unit

“…The PlaNeT-2 study is a large multicenter study conducted in several European countries that is comparing liberal vs. restrictive prophylactic platelet transfusion strategies in thrombocytopenic preterm infants (50 vs. 25 × 10 9 /L, respectively). 37 Approximately 350 infants have been enrolled to date, of a planned total of 600 (Stanworth, Personal Communication).…”

“…Acknowledging the paucity of solid evidence to guide transfusion decisions, and while awaiting the results of the PlaNeT 2 trial, 37 we currently recommend transfusing neonates according to the levels shown in Table 1.…”

Cardiovascular Alterations and Multiorgan Dysfunction After Birth Asphyxia

“…British guidelines suggest keeping platelet counts greater than 20 to 30,000 ×10 6 /L in stable newborns, and transfuse platelets if less than 50,000 ×10 6 /L in sick infants with active bleeding or coagulation defects [81, 82]. The Platelets for Neonatal Transfusion - Study 2 (PlaNeT-2) is a randomized study of high and low platelet transfusion thresholds in newborn and is currently being conducted in Europe [83]. Until further studies are performed, each individual clinician must decide whether treating thrombocytopenia in a stable, non-bleeding asphyxiated infant is necessary.…”