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Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage

This study has been withdrawn prior to enrollment.
(Time constraints)
Information provided by (Responsible Party):
Stephan Munich, Rush University Medical Center Identifier:
First received: June 12, 2013
Last updated: November 9, 2015
Last verified: November 2015
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 Intervention Phase
Subarachnoid Hemorrhage
Cerebral Vasospasm
Cerebral Aneurysm
Drug: Tissue Plasminogen Activator
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage

Resource links provided by NLM:

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • 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:
  • 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.

  • Rate of intracranial infection [ Time Frame: 1-14 after SAH ]
    The presence of infection will require identification of an offending organism via CSF cultures.

Enrollment: 0
Study Start Date: March 2015
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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


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

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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Please refer to this study by its identifier: NCT01878136

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
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

Responsible Party: Stephan Munich, Neurosurgery Resident, Rush University Medical Center Identifier: NCT01878136     History of Changes
Other Study ID Numbers: 13011803
Study First Received: June 12, 2013
Last Updated: November 9, 2015

Additional relevant MeSH terms:
Intracranial Aneurysm
Brain Diseases
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017