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TerminatedPhase 3

Intraventricular Fibrinolysis for Aneurysmal Subarachnoid Hemorrhage.

Reason given: lack of patient

Key facts

Phase
Phase 3

This trial has no sites in United States.

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Trial details

Who runs it
University Hospital, Caen
Trial code
NCT03187405
Record updated
25 July 2025
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT03187405