Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage

• Status: Withdrawn
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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 aneurysmal subarachnoid hemorrhage.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Plasminogen; Tissue Plasminogen Activator

Criteria

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.