Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Subarachnoid Hemorrhage; Cerebral Vasospasm; Cerebral Aneurysm; Hydrocephalus	Drug: Tissue Plasminogen Activator	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage
Study Start Date :	March 2015
Estimated Primary Completion Date :	September 2016
Estimated Study Completion Date :	September 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 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	Drug: 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); Other Names: Activase; Alteplase
Placebo Comparator: Placebo; Placebo Dose 1 mL sterile saline	Drug: 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); Other Names: Activase; Alteplase

Outcome Measures

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Primary Outcome Measures :

1. Composite Primary Outcome [ Time Frame: 1-60 days after SAH ]
   The composite primary outcome will consist of the rates of ventriculoperitoneal shunt (VPS) placement, clinically significant vasospasm, and death. VPS placement serves as surrogate measure of hydrocephalus. These outcomes will be measured during the patient's hospitalization.

Secondary Outcome Measures :

1. Rate of new intracranial hemorrhage [ Time Frame: 1-14 days after SAH ]
   New intracranial hemorrhage will be defined as any new parenchymal or ventricular hemorrhage occurring after the first dose of study drug/placebo.
2. Rate of intracranial infection [ Time Frame: 1-14 after SAH ]
   The presence of infection will require identification of an offending organism via CSF cultures.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612

Sponsors and Collaborators

Rush University Medical Center

Investigators

Principal Investigator:	Stephan Munich, MD	Rush University Medical Center, Department of Neurosurgery
Study Director:	Roham Moftakhar, MD	Rush University Medical Center, Department of Neurosurgery

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Stephan Munich, Neurosurgery Resident, Rush University Medical Center
ClinicalTrials.gov Identifier:	NCT01878136 History of Changes
Other Study ID Numbers:	13011803
First Posted:	June 14, 2013
Last Update Posted:	November 11, 2015
Last Verified:	November 2015

Additional relevant MeSH terms:

Aneurysm; Intracranial Aneurysm; Brain Diseases; Hemorrhage; Subarachnoid Hemorrhage; Hydrocephalus; Vasospasm, Intracranial; Pathologic Processes; Vascular Diseases; Cardiovascular Diseases	Intracranial Hemorrhages; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Plasminogen; Tissue Plasminogen Activator; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action