Background: Each year in the UK, ââ?°Ë?3000 children undergo major cardiac surgery requiring cardiopulmonary bypass.\nApproximately 40 % of these experience excessive bleeding necessitating red cell transfusion or treatment with other\nblood components. A further 40 % receive blood components because of the perception by clinicians that the risk of\nbleeding is high. Excessive bleeding and treatment with red cell transfusion or blood components are associated with\npost-operative complications such as infection and renal injury and are independently associated with increased\nmorbidity and mortality.\nAbnormalities in blood coagulation are a major cause of excessive bleeding after cardiac surgery in children.\nHowever, the extent of these abnormalities varies between children and their characteristics may change rapidly\nduring surgery. In adults undergoing cardiac surgery, rapid testing of blood coagulation using techniques such as\nthromboelastometry may assist the selection of appropriate blood component treatments. In some sub-groups of\nadults, this improves clinical outcomes. Rapid testing of blood coagulation in children undergoing cardiac\nsurgery has not been evaluated fully.\nMethods/Design: The DECISION study is a prospective, single-centre, observational study that aims to assess the\nutility of rapid testing of blood coagulation in children undergoing cardiac surgery. This will be achieved by testing blood\nsamples from 200 children obtained immediately before, and after cardiac surgery. The blood samples will be analysed in\nparallel using thromboelastometry and reference laboratory tests of blood coagulation. The primary clinical outcome will\nbe clinical concern about bleeding, defined as a composite of either excessive blood loss or the use of a pro-haemostatic\ntreatment outside of standard treatment protocols because of perceived high risk of excessive bleeding. The reference\nlaboratory test results will be used to describe the patterns of abnormalities in blood coagulation in children and will be\ncompared to the thromboelastometry test results to determine the diagnostic accuracy of the thromboelastometry tests.\nWe will estimate how well the reference and thromboelastometry test results predict clinical concern about bleeding.\nDiscussion: The DECISION study will identify the most useful thromboeastometry tests of blood coagulation for the\nprediction of excessive bleeding in children after cardiac surgery and will inform the design of future randomised\ncontrolled trials.
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