Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage
Withdrawn before enrolling · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Subarachnoid Hemorrhage, Cerebral Vasospasm, Cerebral Aneurysm, Hydrocephalus
In brief
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 aneurysmal subarachnoid hemorrhage.
Key facts
- Study ID
- NCT01878136
- Run by
- Rush University Medical Center
- People needed
- 0
- Starts
- 2015-03-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2015-11-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Rush University Medical Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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