FIVHeMA: Intraventricular fibrinolysis versus external ventricular drainage alone in aneurysmal subarachnoid hemorrhage: a randomized controlled trial.

Phase 1

Conditions: Patients > 18 years, with aneurysmal SAH complicated by hydrocephalus, requiring insertion of external ventricular drainage
MedDRA version: 20.0Level: LLTClassification code 10042320Term: Subarachnoid hemorrhageSystem Organ Class: 100000013702
Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Registration Number: EUCTR2017-000429-10-FR

Lead Sponsor: CHU CAE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 440

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.
- Patients affiliated to the French Social Security.
- Patients speaking French fluently.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 440
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 440

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the impact of intraventricular fibrinolysis in aneurysmal SAH on functional outcome.;Secondary Objective: - Impact on the risk of death.<br>- Impact on the risk of DCI and symptomatic arterial vasospasm.<br>- Impact on the risk of surgery for internal CSF shunt placement.<br>-Impact on permanent catheter obstruction requiring changing.<br>- Risk of IVF related complications: intracranial bleeding, bacterial meningitis, aseptic meningitis.<br>- Impact on the quality of life and return to work.<br>;Primary end point(s): Functional outcomes evaluated by the modified Rankin Scale (mRS) 6 months after the aneurysm rupture. Proportion of patients without severe disability: mRS = 0-3.;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Impact on the risk of death.<br>- Impact on the risk of DCI and symptomatic arterial vasospasm.<br>- Impact on the risk of surgery for internal CSF shunt placement.<br>-Impact on permanent catheter obstruction requiring changing.<br>- Risk of IVF related complications: intracranial bleeding, bacterial meningitis, aseptic meningitis.<br>- Impact on the quality of life and return to work. <br>;Timepoint(s) of evaluation of this end point: 6 months