Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage
Status: | Withdrawn |
---|---|
Conditions: | Cardiology, Neurology, Women's Studies |
Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | March 2015 |
End Date: | September 2016 |
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.
reduces the rates of cerebral vasospasm and ventriculoperitoneal shunt-dependent
hydrocephalus in patients with aneurysmal subarachnoid hemorrhage.
Inclusion Criteria:
- 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 Criteria:
- 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.
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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