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

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.

Study Overview

• Status: Completed
• Conditions: Blood Coagulation Disorders; Blood Transfusion; C.Surgical Procedure; Cardiac; Bypass, Cardiopulmonary; Hemostatic
• Intervention / Treatment: Device: Thrombo-elastometry POC testing

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.

• Study Type: Interventional
• Enrollment (Actual): 1098
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Angers University Hospital
  • Bordeaux, France
    • Bordeaux university hospital
  • Caen, France
    • CAEN university Hospital
  • Clermont-Ferrand, France
    • Clermont-Ferrand University Hospital
  • Dijon, France
    • Dijon University Hospital
  • Lille, France
    • Lille University Hospital
  • Marseille, France
    • Marseille AP-HM La Timone
  • Nancy, France
    • Nancy University Hospital
  • Paris, France
    • APHP, La Pitié Salpétrière
  • Paris, France
    • HEGP, Hôpital Européen Georges Pompidou
  • Rouen, France
    • Rouen university hospital
  • Saint-Etienne, France
    • Saint-Etienne University Hospital
  • Strasbourg, France
    • Strasbourg Universtiy Hospital
  • Toulouse, France
    • Toulouse University Hospital
  • Tours, France
    • Tours university Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional coagulation management; management of perioperative haemorrhage following cardiac surgery using conventional blood coagulation tests.
Experimental: Thrombo-elastometry POC testing; management of perioperative haemorrhage following cardiac surgery using the thrombo-elastometry point of care test.	Device: Thrombo-elastometry POC testing; Use of thrombo-elastometry point of care test and algorithm guided predetermined intervention during peri operative haemorrhage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-utility ratio	incremental cost per incremental life year and incremental costs per incremental QALY	one year

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Bertrand Rozec, PUPH, Nantes university hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2017
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Cardiopulmonary Bypass; blood transfusion; Hemorrhage; Point-of-care test; health economics
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Intraoperative Complications; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Blood Loss, Surgical
• Other Study ID Numbers: RC16_0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No