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

Blood Transfusion Clinical Trial

— IMOTEC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972684
• Other study ID #: RC16_0009
• Status: Completed
• Phase: N/A
• Start date: January 3, 2017
• Est. completion date: February 2020

Study information

• Verified date: February 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1098
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Pre-Inclusion Criteria:

• Adult patients over 18 years old scheduled for elective or urgent cardiac surgery using cardiopulmonary bypass .

• Patient informed written consent (non-opposition to data use) or person of trust or family member information .

Inclusion Criteria:

Blood Coagulation test sampling indication for intra or post-operative bleeding defined as follow:

1. intra-operative post CPB bleeding; evaluation more than 10min after heparin reversal by protamin.

• Clinically significant bleeding judged on surgeon and anesthesiologist consensual point of view

• Sternal closure delay

• Chest tube bleeding exceeding 50ml in 10min or more than 1ml/kg in 30min (2ml/kg/h)

2. Postoperative period , evaluation in post operative care environment after 30min stabilization period

• Chest tube bleeding exceeding 50ml in 10min or more than 1ml/kg in 30min (2ml/kg/h)

• Patient requiring surgical re-exploration for diagnosed or suspected pericardial effusion or surgical site bleeding requiring surgical hemostatic intervention

Exclusion Criteria:

• Known congenital bleeding disorder

• Redo surgery for patient previously included in the study

• Implantation of Cardiac support device, Extra Corporeal Membrane Oxygenation (ECMO) Extra Corporeal Life support (ECLS), uni or bi-ventricular artificial hearts.

• Indication for post-CPB ECMO or ECLS

• blood transfusion refusal

• pregnant women

• patients under 18 years old

• Adult patient under guardianship, trusteeship or safeguard justice

Related Conditions & MeSH terms

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

Intervention

Device:
• Thrombo-elastometry POC testing
Use of thrombo-elastometry point of care test and algorithm guided predetermined intervention during peri operative haemorrhage

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Bordeaux University hospital	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

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost-utility ratio	incremental cost per incremental life year and incremental costs per incremental QALY	one year
Secondary	incremental cost effectiveness ratio	incremental cost effectiveness ratio : difference in costs divided by the difference in mortality and serious adverse events	one year
Secondary	Complication rates	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
Secondary	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
Secondary	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
Secondary	The location of the Thrombo-elastometry POC testing	The location of the Thrombo-elastometry POC testing (operative room or laboratory)	three years