NCT02972684

Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery With Cardiopulmonary Bypass

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,098 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• C.Surgical Procedure; Cardiac
• Blood Transfusion
• Blood Coagulation Disorders
• Bypass, Cardiopulmonary
• Hemostatic

Interventions

Type	Name	Description
DEVICE	Thrombo-elastometry POC testing	Use of thrombo-elastometry point of care test and algorithm guided predetermined intervention during peri operative haemorrhage

Timeline

• Start date: 2017-01-03
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2016-11-23
• Last updated: 2020-02-13

Locations

15 sites across 1 country: France