Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage
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ClinicalTrials.gov Identifier: NCT01878136 |
Recruitment Status
:
Withdrawn
(Time constraints)
First Posted
: June 14, 2013
Last Update Posted
: November 11, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Subarachnoid Hemorrhage Cerebral Vasospasm Cerebral Aneurysm Hydrocephalus | Drug: Tissue Plasminogen Activator | Phase 1 Phase 2 |
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 |

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:
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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:
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- 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.
- 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.

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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878136
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 |
Principal Investigator: | Stephan Munich, MD | Rush University Medical Center, Department of Neurosurgery | |
Study Director: | Roham Moftakhar, MD | Rush University Medical Center, Department of Neurosurgery |
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 Key Record Dates |
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 |