AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding (NCT04804345) | Clinical Trial Compass
CompletedNot Applicable
AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding
France693 participantsStarted 2021-03-31
Plain-language summary
In this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe perioperative bleeding.
Who can participate
Age range
18 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:
patients undergoing cardiac on pump surgery at high risk for bleeding defined by :
* Aorto-coronary bypasses surgery (2 or more) under dual platelet aggregation therapy (Primary or redo)
* Heart transplant (Primary or Redo)
* Infectious endocarditis (Primary or Redo)
* Ascending acute aortic dissection (Primary or Redo)
* Artificial heart / LVAD under CEC (Primary or Redo)
* Combined surgery, Redo
* Ascending aorta surgery, Redo
Exclusion Criteria:
* Off pump cardiac surgery
* Patient not meeting the inclusion criteria
* Patient not receiving antifibrinolytic therapy
* Patient with absolute contraindication to antifibrinolytics,
* Patient refusing to give access to their medical chart,
* Patient not meeting the inclusion criteria
* Patient protected by the law, under guardianship or trusteeship,
* Patient deprived of liberty
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.
What they're measuring
1
Proportion of patients with severe peri-operative bleeding