Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage

NCT ID: NCT01878136

Last Updated: 2015-11-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-09-30

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 aneurysmal subarachnoid hemorrhage.

Conditions

Subarachnoid Hemorrhage; Cerebral Vasospasm; Cerebral Aneurysm; Hydrocephalus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Intraventricular tPA

Tissue Plasminogen Activator (tPA)

Dose: 1 mg Q8 hr x 12 doses, or until blood is cleared from the ventricles and cisterns Adminstration: Intraventricular; via previously placed external ventricular drain

Group Type: ACTIVE_COMPARATOR

Tissue Plasminogen Activator

Intervention Type: DRUG

Dose: 1mg Q8 x 12 doses, or until clearance of blood from ventricles and cisterns Administration: intraventricular administration (through external ventricular drain)

Placebo

Placebo

Dose 1 mL sterile saline

Group Type: PLACEBO_COMPARATOR

Tissue Plasminogen Activator

Intervention Type: DRUG

Dose: 1mg Q8 x 12 doses, or until clearance of blood from ventricles and cisterns Administration: intraventricular administration (through external ventricular drain)

Interventions

Tissue Plasminogen Activator

Dose: 1mg Q8 x 12 doses, or until clearance of blood from ventricles and cisterns Administration: intraventricular administration (through external ventricular drain)

Intervention Type: DRUG

Other Intervention Names

Activase; Alteplase

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Stephan Munich

Neurosurgery Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephan Munich, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center, Department of Neurosurgery

Roham Moftakhar, MD

Role: STUDY_DIRECTOR

Rush University Medical Center, Department of Neurosurgery

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

13011803

Identifier Type: -

Identifier Source: org_study_id