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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional coagulation management | No Intervention | management of perioperative haemorrhage following cardiac surgery using conventional blood coagulation tests. | |
| Thrombo-elastometry POC testing | Experimental | management of perioperative haemorrhage following cardiac surgery using the thrombo-elastometry point of care test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombo-elastometry POC testing | Device | Use of thrombo-elastometry point of care test and algorithm guided predetermined intervention during peri operative haemorrhage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cost-utility ratio | incremental cost per incremental life year and incremental costs per incremental QALY | one year |
| Measure | Description | Time Frame |
|---|---|---|
| incremental cost effectiveness ratio | incremental cost effectiveness ratio : difference in costs divided by the difference in mortality and serious adverse events | one year |
| Complication rates |
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Pre-Inclusion Criteria:
Inclusion Criteria:
Blood Coagulation test sampling indication for intra or post-operative bleeding defined as follow:
intra-operative post CPB bleeding; evaluation more than 10min after heparin reversal by protamin.
Postoperative period , evaluation in post operative care environment after 30min stabilization period
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bertrand Rozec, PUPH | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers University Hospital | Angers | France | ||||
| Bordeaux University hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31694845 | Background | Rigal JC, Boissier E, Lakhal K, Riche VP, Durand-Zaleski I, Rozec B. Cost-effectiveness of point-of-care viscoelastic haemostatic assays in the management of bleeding during cardiac surgery: protocol for a prospective multicentre pragmatic study with stepped-wedge cluster randomised controlled design and 1-year follow-up (the IMOTEC study). BMJ Open. 2019 Nov 5;9(11):e029751. doi: 10.1136/bmjopen-2019-029751. | |
| 41274376 |
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Parameters followed during hospitalization are: volume of postoperative bleeding, allogeneic blood product transfusion, blood cell count, postoperative complications: surgical reexploration, acute kidney injury, need for renal replacement therapy, organ failure, acquired infections, mechanical ventilation duration, intensive care, and in hospital length of stay, death.
| one year |
| Complication rates | The major complications that can occur within 12 months are: death, cardio-thoracic surgical intervention, acute kidney injury, need for renal replacement therapy, any serious illness diagnosis. | one year |
| Evaluation survey | Evaluation survey regarding the context and the parameters that impacted the physician's decision, which will be used a sub-group of 100 patients. | Day 1 |
| The location of the Thrombo-elastometry POC testing | The location of the Thrombo-elastometry POC testing (operative room or laboratory) | three years |
| Bordeaux |
| France |
| Caen University Hospital | Caen | France |
| Clermont-Ferrand University Hospital | Clermont-Ferrand | France |
| Dijon University Hospital | Dijon | France |
| Lille University hospital | Lille | France |
| Marseille AP-HM La Timone | Marseille | France |
| Nancy University Hospital | Nancy | France |
| APHP, La Pitié Salpétrière | Paris | France |
| HEGP, Hôpital Européen Georges Pompidou | Paris | France |
| Rouen University Hospital | Rouen | France |
| Saint-Etienne University Hospital | Saint-Etienne | France |
| Strasbourg Universtiy Hospital | Strasbourg | France |
| Toulouse University Hospital | Toulouse | France |
| Tours University Hospital | Tours | France |
| Derived |
| Vourc'h M, Boissier E, Lakhal K, Grosjean S, Labaste F, Robin E, Bougle A, Mattei M, Morel J, Wurtz V, Mertes PM, Zlotnik D, Lagier D, Beurton A, Rineau E, Fischer MO, May MA, Medard A, Guimbretiere G, Durand-Zaleski I, Pere M, Rozec B, Rigal JC. Cost-utility of point-of-care viscoelastic hemostatic assays in the management of bleeding during cardiac surgery: A single-blinded prospective multicenter stepped wedge cluster randomized trial in French context. Anaesth Crit Care Pain Med. 2026 May;45(3):101704. doi: 10.1016/j.accpm.2025.101704. Epub 2025 Nov 20. |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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