title: Detection of coagulopathy in paediatric heart surgery [DECISION study]: study protocol.
abstract: BACKGROUND
  Each year in the UK, ≈3000 children undergo major cardiac surgery requiring cardiopulmonary bypass. Approximately 40 % of these experience excessive bleeding necessitating red cell transfusion or treatment with other blood components. A further 40 % receive blood components because of the perception by clinicians that the risk of bleeding is high. Excessive bleeding and treatment with red cell transfusion or blood components are associated with post-operative complications such as infection and renal injury and are independently associated with increased morbidity and mortality. Abnormalities in blood coagulation are a major cause of excessive bleeding after cardiac surgery in children. However, the extent of these abnormalities varies between children and their characteristics may change rapidly during surgery. In adults undergoing cardiac surgery, rapid testing of blood coagulation using techniques such as thromboelastometry may assist the selection of appropriate blood component treatments. In some sub-groups of adults, this improves clinical outcomes. Rapid testing of blood coagulation in children undergoing cardiac surgery has not been evaluated fully.
  
  
  METHODS
  The DECISION study is a prospective, single-centre, observational study that aims to assess the utility of rapid testing of blood coagulation in children undergoing cardiac surgery. This will be achieved by testing blood samples from 200 children obtained immediately before, and after cardiac surgery. The blood samples will be analysed in parallel using thromboelastometry and reference laboratory tests of blood coagulation. The primary clinical outcome will be clinical concern about bleeding, defined as a composite of either excessive blood loss or the use of a pro-haemostatic treatment outside of standard treatment protocols because of perceived high risk of excessive bleeding. The reference laboratory test results will be used to describe the patterns of abnormalities in blood coagulation in children and will be compared to the thromboelastometry test results to determine the diagnostic accuracy of the thromboelastometry tests. We will estimate how well the reference and thromboelastometry test results predict clinical concern about bleeding.
  
  
  CONCLUSIONS
  The DECISION study will identify the most useful thromboeastometry tests of blood coagulation for the prediction of excessive bleeding in children after cardiac surgery and will inform the design of future randomised controlled trials.
  
  
  BACKGROUND
  The trail was registered as ISRCTN55439761 on 23(rd) April 2015.
authors: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors: Wendy
authors: W
authors: Underwood
authors: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors: Chris A
authors: CA
authors: Rogers
authors: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors: Zoe
authors: Z
authors: Plummer
authors: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors: Barnaby
authors: B
authors: C Reeves
authors: The Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors: Massimo
authors: M
authors: Caputo
authors: Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors: Peter
authors: P
authors: Murphy
authors: Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors: Karen
authors: K
authors: Sheehan
authors: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors: Jessica
authors: J
authors: Harris
authors: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors: Lucy
authors: L
authors: Culliford
authors: School of Cellular and Molecular Medicine, University of Bristol, Bristol, UK.
authors: Andrew
authors: A
authors: Mumford
keywords: Cardiopulmonary bypass; Coaugulation; Heart surgery; Paediatric; Rotational TEM; Thromboelastometry