Status:
WITHDRAWN
Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage
Lead Sponsor:
Rush University Medical Center
Conditions:
Subarachnoid Hemorrhage
Cerebral Vasospasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate the hypothesis that the administration of intraventricular tPA reduces the rates of cerebral vasospasm and ventriculoperitoneal shunt-dependent hydrocephalus in patients with ...
Eligibility Criteria
Inclusion
- Age greater than 18 years old.
- SAH due to aneurysm, as determined by CT angiogram or cerebral angiogram.
- Modified Fisher (mF) grade 3 or 4 SAH, defined as thick cisternal blood without (grade 3) or with (grade 4) intraventrciular blood.
- Exclusion of the aneurysm from the parent circulation by endovascular embolization (Raymond class I or II) within 48 hours of ictus.
- Ventriculostomy placement must occur prior to randomization.
- Informed consent obtained from the patient or patient's decision maker
Exclusion
- Determination by treating physician(s) that no ventriculostomy is needed.
- Presence of intrinsic clotting disorders (e.g. due to hepatic failure, nephrotic syndrome, etc). Subjects whose pharmacologic anticoagulation is reversed, as determined by PT/INR, PTT within our institution's normal range, will be permitted to participate in this study.
- Presence of significant anemia, defined as hemoglobin \< 8 gm/dL.
- Patients who undergo endovascular techniques requiring post-operative dual anti-platelet therapy.
- Residual aneurysm sac filling (Raymond class III occlusion).
- Aneurysm or vessel perforation during the endovascular procedure.
- Presence of craniectomy.
- Significant neurologic disability prior to the onset of SAH.
- Determination that administration of tPA/placebo cannot be initiated within 72 hours of symptom onset.
- Presence of untreated intracranial aneurysms larger than 3mm on CT angiography or cerebral angiogram.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01878136
Start Date
March 1 2015
End Date
September 1 2016
Last Update
November 11 2015
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612