Patients > 18 years, with aneurysmal SAH complicated by hydrocephalus, requiring insertion of external ventricular drainage MedDRA version: 20.1 Level: LLT Classification code 10042320 Term: Subarachnoid hemorrhage System Organ Class: 100000004852
Conditions
Sponsors
CHU CAEN
Eligibility
Sex/Gender
All
Inclusion 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 ruptured 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
Exclusion criteria: - Patient with severe clinical presentation at randomization: WFNS score = 5 not corrected by the medical care and the external ventricular drainage (or last WFNS score before sedation = 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 with platelet anomaly: patient previously treated with antiplatelet therapy or treated with antiplatelet therapy after the ruptured aneurysm exclusion or platelet count <100 000 /mm3. - Severe coagulopathy, including oral vitamin K antagonist. - Pregnant or lactating woman.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the impact of intraventricular fibrinolysis in aneurysmal SAH on functional outcome.;Secondary Objective: - Impact on the risk of death. - Impact on the risk of DCI and symptomatic arterial vasospasm. - Impact on the risk of surgery for internal CSF shunt placement. -Impact on permanent catheter obstruction requiring changing. - Risk of IVF related complications: intracranial bleeding, bacterial meningitis, aseptic meningitis. - Impact on the quality of life and return to work. ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Impact on the risk of death. - Impact on the risk of DCI and symptomatic arterial vasospasm. - Impact on the risk of surgery for internal CSF shunt placement. -Impact on permanent catheter obstruction requiring changing. - Risk of IVF related complications: intracranial bleeding, bacterial meningitis, aseptic meningitis. - Impact on the quality of life and return to work. ;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
France, Norway
Contacts
Public ContactRegulatory Affairs
CHU CAEN
Outcome results
None listed