Intraventricular Fibrinolysis for Aneurysmal Subarachnoid Hemorrhage.
Stopped: lack of patient
France81 participantsStarted 2018-02-21
Plain-language summary
Aneurysmal subarachnoid hemorrhage (SAH) is a devastating form of stroke, with delayed cerebral ischemia (DCI) as a major complication. There are several evidences, both in preclinical and in clinical studies that intraventricular fibrinolysis (IVF) controls the phenomenon that are leading to DCI. Here, the investigators propose to conduct a phase III trial to provide a clear evaluation of the impact of IVF after aneurysmal SAH.
Who can participate
Age range
18 Years – 75 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 (age 18-75) with SAH on initial CT-Scan examination.
* SAH associated with hydrocephalus requiring external ventricular drainage.
* Confirmation of an associated intracranial aneurysm by vascular imaging.
* Time from onset to admission under 24 hours.
* Exclusion of the aneurysm by surgical clipping or endovascular coiling before IVF.
* Oral information on research and informed consent of the patient and/or his relatives.
Exclusion Criteria:
* Patient with severe clinical presentation on admission: WFNS score = 5.
* Associated intracerebral hematoma of more than 2 cm in its larger width.
* SAH diagnosed on lumbar puncture: original Fisher grade = 1.
* Impossibility to exclude the aneurysm within 72 hours following its rupture.
* Patient previously treated with antiplatelet therapy or treated with antiplatelet therapy after the aneurysm exclusion.
* Severe coagulopathy, including oral vitamin K antagonist.
* 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.
What they're measuring
1
Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis.