Blood Transfusion Clinical Trial
Official title:
Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery Using Conventional Blood Coagulation Tests or Thrombo-elastographic Point of Care Test - IMOTEC
Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of cardiac
surgical interventions.
Treatment of such complication often necessitates various combinations therapeutic
intervention including allogenic blood products administration, drug use and/or surgical
intervention. All are expensive treatment and decision making is guided by patient clinical
status and biological tests of the haemostatic function.
A key point is the time frame of the clinical process. Therapeutic choices have to be done as
fast as possible to minimize bleeding consequences on patient haemodynamic and physiological
status. Conventional coagulation test results availability time usually exceed 45' after
blood drawing. In such situation, the results may not reflect precisely the coagulation
system current state. This downside is often counterbalanced by clinicians empirical choices
preceding lab test results knowledge that may conduct to inappropriate treatment, blood
product overuse and undue expense.
Viscoelastic point of care test may compensate for the limitations of conventional
coagulation tests. In perioperative haemorrhage, faster and more precise information about
haemostatic function may help for more accurate therapeutic choices.
The IMOTEC study aims to compare haemorrhage management following cardiac surgery using
conventional blood coagulation tests or thrombo-elastogaphic point of care test.
Primary endpoint is a cost utility analysis of the technology and secondary endpoints include
blood component transfusion, postoperative bleeding , thoracic re-intervention, postoperative
infection (any cause), organ failure, in hospital length of stay and death.
The research is a real life, prospective, single blinded stepped wedge randomized study.
Inclusion after informed consent of adult patient having cardio-vascular surgical procedure
using cardiopulmonary bypass and meeting inclusion criterion "bleeding".
After meeting inclusion criterion patients are managed either using conventional blood
coagulation tests or using thrombo-elastometry POC test and predefined therapeutic
interventions described in a specific algorithm.
Other elements of patient clinical management follow usual center standard care .
Follow up of EQ-5D and clinical evaluations are performed at one , 6 and 12 months after
inclusion.
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