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

NCT02972684 | Completed

• 1 other identifier: RC16_0009
• Study Type: interventional
• Target: 1,098
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

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

Keywords

Cardiopulmonary Bypass; Hemorrhage; blood transfusion; Point-of-care test; health economics

Outcome Measures

Primary Outcomes (1)

• Cost-utility ratio

  incremental cost per incremental life year and incremental costs per incremental QALY

  one year

Secondary Outcomes (5)

• incremental cost effectiveness ratio

  one year

• Complication rates

  one year

• Complication rates

  one year

• Evaluation survey

  Day 1

• The location of the Thrombo-elastometry POC testing

  three years

Study Arms (2)

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.

Device: Thrombo-elastometry POC testing

Interventions

Thrombo-elastometry POC testing DEVICE

Use of thrombo-elastometry point of care test and algorithm guided predetermined intervention during peri operative haemorrhage

Thrombo-elastometry POC testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .
• 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.
• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Ministry of Health, France: collaborator

Study Sites (15)

Angers University Hospital

Angers, France

Location

Bordeaux University hospital

Bordeaux, France

Location

Caen University Hospital

Caen, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, France

Location

Dijon University Hospital

Dijon, France

Location

Lille University hospital

Lille, France

Location

Marseille AP-HM La Timone

Marseille, France

Location

Nancy University Hospital

Nancy, France

Location

APHP, La Pitié Salpétrière

Paris, France

Location

HEGP, Hôpital Européen Georges Pompidou

Paris, France

Location

Rouen University Hospital

Rouen, France

Location

Saint-Etienne University Hospital

Saint-Etienne, France

Location

Strasbourg Universtiy Hospital

Strasbourg, France

Location

Toulouse University Hospital

Toulouse, France

Location

Tours University Hospital

Tours, France

Location

Related Publications (2)

• 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.

  PMID: 31694845 BACKGROUND

• 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. 2025 Nov 20:101704. doi: 10.1016/j.accpm.2025.101704. Online ahead of print.

  PMID: 41274376 DERIVED

MeSH Terms

Conditions

Blood Coagulation Disorders; Hemorrhage

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bertrand Rozec, PUPH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 23, 2016
• Study Start: January 3, 2017
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)