Transfusion Savings in Heart Surgery: Impact of Individual Strategy by Erythropoietin and Metabol… (NCT04141631) | Clinical Trial Compass
CompletedNot Applicable
Transfusion Savings in Heart Surgery: Impact of Individual Strategy by Erythropoietin and Metabolic Adjustment (ScvO2)
France128 participantsStarted 2020-01-13
Plain-language summary
Preoperative anemia, bleeding and transfusions have been recognized as a "Deadly triad" in cardiac surgery associated with an increased morbidity,mortality, and costs related. Thus strategies to reduce unnecessary RBC transfusions and to optimize preoperative anemia must be developed .The study evaluate an individual blood conservation strategy based on patient blood management bundles in cardiac surgery patients: optimisation perioperative hemoglobin level by erythropoietin and ferric carboxymaltose (Ferinject) associated with the use of ScV02 to guide perioperative erythrocyte transfusion.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Scheduled Cardiac surgery for more than 24 hours
* High risk of perioperative transfusion defined by a TRUST Score ≥ 3
* Veno-Venous catheter in Superior vena cava territory
* Patient Affiliate or beneficiary of social security
* Collection on free, informed and written consent
Exclusion Criteria:
* EPO and FCM contraindication
* Patients already treated by EPO at the time of inclusion
* Non controlled Infectious endocarditis defined by ESC guidelines 2015
* Patients including in an other research
* Patients whose physical and/or psychological health is severely impaired and who, according to the investigator, may affect the participant's compliance with the study.
* Patients deprived from his rights (guardianship or tutelage measure)
* Patients who refuses to sign the consent
* pregnant or lactating woman
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.