Intraventricular Fibrinolysis for Aneurysmal Subarachnoid Hemorrhage.

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Caen
• Treatments: Tissue Plasminogen Activator

Criteria

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.