Incidence of Acute Cerebrovascular Events Using Either Minimized or Standard Cardiopulmonary Bypa… (NCT00862160) | Clinical Trial Compass
UnknownPhase 4
Incidence of Acute Cerebrovascular Events Using Either Minimized or Standard Cardiopulmonary Bypass Circuit
Germany64 participantsStarted 2009-04
Plain-language summary
The prospective, randomized, two centre study investigates acute cerebrovascular events during extracorporal circulation and the early post operative outcome when using either the minimized cardiopulmonary bypass circuit (ROCsafeTM) or a standard cardiopulmonary bypass circuit in patients undergoing coronary artery bypass grafting.
Who can participate
Age range
18 Years – 80 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:
* Patient is older than 17 years
* Patient is acceptable candidate for CABG operation
* Patient or the patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.
Exclusion Criteria:
* Ejection fraction less than 30 %
* Valve surgery
* Acute endocarditis or history of endocarditis
* Cerebral ischemia within 4 weeks before surgery
* Detection of intracardial thrombi in preoperative echocardiography
* Stenosis of A. carotis int. greater than 70 %
* Patients older than 80 years
* Patients on dialysis
* Acute myocardial ischemia or infarction within two weeks before inclusion
* Markedly elevated baseline C-reactive protein (CRP) or leucocytosis
* Cancer or immunologic diseases
* Dysregulation of the coagulation cascade (not concerning INR or PTT under cumarin or heparin treatment)
* Intake of steroids or NSAR
* Female of childbearing potential
* Participation in an other study
* Contraindication for MRI (e.g. pacemaker, any kind of implanted metal)
* Claustrophobia
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.