Interchangeability of Arterial Coagulation and Venous Coagulation, in the Context of Cardiac Surgeries Under Cardiopulmonary Bypass, Using the DMDiv Hemochron Signature Elite
Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · May 16, 2023
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well a device called the Hemochron Signature Elite® measures blood clotting during heart surgeries that use a heart-lung machine (also known as cardiopulmonary bypass). The main focus is to see if there is a difference in the results when testing blood taken from an artery compared to blood taken from a vein. This is important because the type of blood sampled might affect the accuracy of the measurements, which are crucial for ensuring patients receive the right amount of a blood thinner called heparin during surgery.
To participate in this trial, patients need to be at least 18 years old and scheduled for certain types of heart surgeries, such as valve replacements or bypass surgery. They must also be covered by Social Security in France and give their written consent to take part. During the trial, patients can expect to have their blood tested using both arterial and venous samples to help determine the most reliable way to monitor blood clotting during surgery. It's important to note that certain patients, such as those undergoing emergency surgeries or with specific medical conditions, are not eligible to participate. This study aims to enhance the safety and effectiveness of anticoagulation during heart surgeries, ultimately improving patient care.
Gender
ALL
Eligibility 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
About Centre Hospitalier Universitaire, Amiens
The Centre Hospitalier Universitaire (CHU) Amiens is a leading academic medical center in France dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on multidisciplinary collaboration, CHU Amiens integrates patient care, education, and research to enhance treatment outcomes and improve patient quality of life. The institution is committed to ethical standards and regulatory compliance in its clinical research endeavors, aiming to contribute significantly to the medical community and the development of new therapeutic approaches. By fostering partnerships with various stakeholders, CHU Amiens strives to translate scientific discoveries into practical applications that benefit patients and healthcare systems alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Amiens, Picardie, France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported