Cerebral Microemboli in Venoarterial ECMO Patients
Austria20 participantsStarted 2014-06
Plain-language summary
Extracorporeal membrane oxygenation (ECMO) is progressively used in critically ill patients with cardiac or respiratory failure as a bridging option for potential organ recovery. However, ECMO survivors often suffer from poor neurocognitive outcome due to neurological complications such as microembolic (ME) strokes.
In venoarterial (va) ECMO circuits the pulmonary circulation, which usually serves as microembolic filter, may be bypassed and generated ME are prone to reach the brain in substantial amounts and potentially impair cerebral integrity. Although patient exposure to cerebral ME has been thoroughly investigated in cardiopulmonary bypass procedures, there is only limited research on cerebral ME in patients undergoing ECMO therapy.
The primary study goal of this study is to determine the load and nature of cerebral ME in critically ill patients under va-ECMO support. We also aim to compare the results to measurements in healthy subjects und intensive care unit (ICU) patients without extracorporeal support to get a better impression on the relevance of ME generation during ECMO support.
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 (for patients):
* Intensive care patients with cardiac or respiratory failure under va-ECMO therapy
* Age \> 18 yrs.
* Signed informed consent
Exclusion Criteria:
* use of any other extracorporeal device including venovenous (vv) ECMO
* continuous renal replacement therapy
* medical history of severe mitral or aortic stenosis
* medical history of severe mitral or aortic regurgitation
* medical history of carotid stenosis \> 70 %
* septicaemia
* medical history of vascular dementia or Alzheimer's disease
* inclusion in an other clinical study
* gravidity
* allergy against materials of one of the medical device used in the study
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.