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PlaNeT-1

PLEASE NOTE: This study is now complete.

Title
PlaNeT-1
PlaNeT-1
Study Type
PlaNeT-1
Observational study
Chief Investigator(s)
PlaNeT-1
Dr Simon Stanworth
Dr Neil Murray
Primary Sponsor
PlaNeT-1
NHSBT
Summary
PlaNeT-1

This study will yield good descriptive data on current transfusion practice, and about the relationship of neonatal thrombocytopenia to clinically relevant bleeding events.

We believe that this study is the first stage in the process of standardising and improving current neonatal platelet transfusion practice. It will provide information essential for the design of definitive trials of transfusion triggers for prophylaxis in neonates, and will assess the practicalities of developing methodology to collect transfusion and bleeding data.

The data may also be used to develop a standardised platelet transfusion administration and monitoring algorithm suitable for use across different neonatal centres. Finally, we believe the study and methodology have evident value for strategies and studies aimed at evaluating the usage of other blood components in neonates (e.g. red cells and FFP).

Study Hypothesis
PlaNeT-1

The hypotheses underpinning this study are as follows:

1.) Significant thrombocytopenia (a platelet count below 60 x 109/L) is a common occurrence in neonatal medicine
2.) Platelet transfusion is a common occurrence in neonatal medicine
3.) Indications for platelet transfusion vary significantly between units
4.) Platelet transfusion practice varies significantly between units, and
5.) There is no relationship between thrombocytopenia and major or minor bleeding in NICU patients

Study Design
PlaNeT-1

The study is a cohort observational study.

This study is the beginning of a clinical research process whose overall objectives are to:

1.) Standardise neonatal platelet transfusion practice in the UK
2.) Optimise neonatal platelet transfusion practice in the UK.

Data from this study will inform the design of randomised multi-centre platelet transfusion trials in neonates. In particular, the data will inform:

1.) Appropriate platelet trigger thresholds for comparison
2.) Patient inclusion and exclusion criteria
3.) A standardised platelet transfusion administration and monitoring protocol
4.) Appropriate clinical end points and safety parameters.

Publications
PlaNeT-1

Stanworth SJ, Clarke P, Watts T, Ballard S, Choo L, Morris T; Murphy MF, Roberts I. A for the Platelets and Neonatal Transfusion Study Group. Prospective, observational study of outcomes in neonates with severe thrombocytopenia. Pediatrics 2009;124: 826-834.

Muthukumar P, Venkatesh V, Curley A, Kahan BC, Choo L, Ballard S, Clarke P, Watts T, Roberts I, Stanworth S, for the Platelets Neonatal Transfusion Study Group. Severe thrombocytopenia and patterns of bleeding in neonates: results from a prospective observational study and implications for use of platelet transfusions. Transfusion Medicine 2012; 22: 338-43 [E Pub 27Jun 2012 doi:10.1111/j.1365-3148.2012.01171.x]