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Status:Withdrawn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

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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.


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.
We found this trial at
1
site
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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from
Chicago, IL
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