Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT04588350
Eligibility Criteria:
Inclusion Criteria:
Preoperative Inclusion Criteria:
* Is the patient able and willing to give informed consent before participating in the study?
* Is the patient aged ≥ 18 years?
* Does the patient have a social protection system?
* Does the patient weigh ≥ 59kg (for the sole purpose of blood assessment related to the clinical study)?
* Is the patient indicated for a cardiac surgery with the implementation of a Cardio Pulmonary Bypass (CPB)?
* Does the patient have a preoperative hemoglobin ≥ 13g / L for a man and ≥ 12g / L for a woman?
* Does the patient have a preoperative platelets count ≥ 150000 / μL?
Intraoperative Inclusion Criteria:
\- Does the patient have anticoagulated blood losses ≥ 500mL (without considering priming volume in the first cycle)?
Exclusion Criteria:
Preoperative Exclusion Criteria:
* Is the patient indicated for a surgery because of a suspected or confirmed cancer?
* Does the patient have any systemic or local infection in the area of intervention, suspected or proven?
* Does the patient have any pathology of hemostasis (Hemophilia, ...) or bleeding disorder confirmed, or strongly suspected on the examination of the patient in consultation (high score on the formalized questionnaire: HEMSTOP)?
* Is the patient's life expectancy of less than 2 months?
* Does the patient have any psychiatric condition that could, in the opinion of the investigator, prevent him / her from participating in this study?
* Does the patient have any objections to transfusion (homologous)?
* Is the patient participating in or has participated in another clinical study in the last 30 days at the day of screening and has received (or is receiving) treatments that could have an impact on the effectiveness of the autotransfusion?
* Does the investigator consider that the patient (or the surgical conditions) is not appropriate to be included in this clinical study?
* Does the patient have a TIH - Heparin-Induced Thrombocytopenia - suspected or confirmed and therefore cannot receive heparin?
* Is the patient pregnant or a lactating woman?
* Is the patient a woman of childbearing age who is not on effective contraceptive treatment?
* Is the patient due to have combined surgeries?
* Has the patient been admitted for an emergency surgery?
* Does the patient have an endocarditis?
* Has the patient been admitted for a redux surgery?
* Has the patient been admitted for a heart transplantation or a mechanical circulatory support surgery?
* Has the patient been admitted for congenital heart surgery?
* Has the patient taken
* any anti-platelet aggregation drugs (except acid acetylsalicylic - aspirin) including Ticagrelor, Clopidogrel and Prasugrel or,
* any anticoagulant drugs (intake of vitamin K antagonists or DOAC = direct oral anti-coagulant including rivaroxaban, Edoxaban, Apixaban and Dabigatran), outside the recommendations from EACTS / EACTA and GHIP?
Intraoperative Exclusion Criteria:
\- Is the "emergency" mode available on the i-Sep machine used during surgery?
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04588350
Study Brief:
Protocol Section:
NCT04588350