Interchangeability of Arterial Coagulation and Venous Coagulation, in the Context of Cardiac Surgeries Under Cardiopulmonary Bypass, Using the DMDiv Hemochron Signature Elite (COAGAV)

Prospective, Monocentric Study of the Interchangeability of Arterial Coagulation and Venous Coagulation, in the Context of Cardiac Surgeries Under Cardiopulmonary Bypass, Using the DMDiv Hemochron Signature Elite

Adequate coagulation measured using activated clotting (ACT) is important during vascular and cardiac surgeries. Unfractionated heparin is the most common anticoagulant used. For point of care testing, under supervision of biology department, the investigators use Hemochron Signature Elite®(HSE) (Werfen®-Barcelona Spain) to determine coagulation during cardiac surgery under Cardiopulmonary Bypass (CPB), with arterial or venous blood. The dosage of heparin varies according to this result, throughout the CPB. On the Connect Manager® software (Livanova®, Italy) which records all the data of a CPB, it is mandatory to inform, during an ACT, the sampling site in arterial or venous. The chemical compositions of arterial blood and venous blood are different (O2, Co2…) Even if the qualities of coagulation in vivo are identical, what happens when they are chemically analyzed using the medical device HSE ? Can we trust the results of this device to secure anticoagulation under CPB? Are the results affected by the sampling site? The objective of this study is to compare the reliability of hemostasis control , during cardiac surgery under cardiopulmonary bypass, for both venous and arterial blood. Effective and controllable anticoagulation is mandatory during cardiac surgeries under extracorporeal circulation. The monitoring of the effectiveness of heparin is carried out, in our center, using the Hemochron Signature Elite® (HSE) medical device, which measures the ACT (Activated Clotting Time). There is no comparative study between hemostasis of venous blood, versus arterial blood, with this point of care device.

Study Overview

• Status: Recruiting
• Conditions: Hemostasis; Extracorporeal Circulation; Heparin; Cardio-pulmonary Bypass
• Intervention / Treatment: Procedure: interchangeability of arterial or venous hemostasis

• Study Type: Observational
• Enrollment (Estimated): 201

Contacts and Locations

• Study Contact: Name: Romain BEAL; Phone Number: 03 22 08 80 00; Email: beal.romain@chu-amiens.fr
• Study Contact Backup: Name: Osama ABOU ARAB, MD; Phone Number: 03 22 08 78 36; Email: abouarab.osama@chu-amiens.fr

Study Locations

• France
  • Amiens, France
    • Recruiting
    • CHU Amiens Picardie
    • Contact: Romain Beal; Phone Number: 03 22 08 78 36; Email: beal.romain@chu-amiens.fr
    • Sub-Investigator: Osama Abou Arab, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 and over, undergoing conventional heart surgery under normothermic Cardiopulmonary Bypass (nadir 34°) (Aortic valve replacement, coronary artery bypass graft surgery, valve plasty, atrial septal defect, ventricular septal defect, intracardiac tumours, heart surgery, ascending aorta, combined surgery…)

Description

Inclusion Criteria:

• Patients aged 18 and over,
• undergoing conventional heart surgery under normothermic Cardiopulmonary Bypass (nadir 34°) (Aortic valve replacement, coronary artery bypass graft surgery, valve plasty, atrial septal defect, ventricular septal defect, intracardiac tumours, heart surgery, ascending aorta, combined surgery…)
• They must be affiliated with Social Security in France, and have given their written consent.

Exclusion Criteria:

• Minor Patients,
• Emergency Cardiac Surgeries, Extracorporeal circulation in hypothermia, Cardiac surgery without CEC
• Patients already included in a research protocol,
• Patient under guardianship or curators or deprived of public law,
• Patient with proven Heparin Induced Thrombopenia (HIT) not receiving heparin
• Pregnant woman, breastfeeding or parturient

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Activated Clotting Time after using the Hemochron Signature Elite® medical device	day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hemostasis; cardio-pulmonary bypass; heparin; Activated Clotting Time; extra corporeal circulation; Hemochron; venous and arterial blood
• Additional Relevant MeSH Terms: Coagulants; Hemostatics
• Other Study ID Numbers: PI2023_843_0057

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No