Intraventricular Fibrinolysis for Aneurysmal Subarachnoid Hemorrhage.
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- Fázis
- 3. fázis
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A vizsgálat adatai
- Ki végzi
- University Hospital, Caen
- Azonosító
- NCT03187405
- A regiszteradat frissítve
- 2025. július 25.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Intraventricular Fibrinolysis Versus External Ventricular Drainage Alone in Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Trial.
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.
Bevonási feltételek: 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.
Kizáró feltételek: Patient previously treated with antiplatelet therapy or treated with antiplatelet therapy after the aneurysm exclusion; 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; Severe coagulopathy, including oral vitamin K antagonist; Pregnant or lactating woman.