Comparing arterial and venous blood coagulation during heart surgeries
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
This study is testing if measuring blood clotting in arteries is just as good as measuring it in veins for patients having heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 201 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT05875272 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the interchangeability of arterial and venous coagulation measurements during cardiac surgeries that utilize cardiopulmonary bypass. It employs the Hemochron Signature Elite device to assess coagulation levels in patients undergoing various heart procedures. The study aims to determine if the chemical differences between arterial and venous blood affect the accuracy of coagulation results, which are critical for safe anticoagulation management during surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over who are scheduled for conventional heart surgeries under normothermic cardiopulmonary bypass.
Not a fit: Patients undergoing emergency surgeries, those with heparin-induced thrombocytopenia, or minors will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of anticoagulation management during cardiac surgeries.
How similar studies have performed: While similar studies have explored coagulation management, this specific comparison of arterial versus venous coagulation in the context of cardiopulmonary bypass is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amiens
- CHU Amiens Picardie — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Romain BEAL
- Email: beal.romain@chu-amiens.fr
- Phone: 03 22 08 80 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.