Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage
This study has been withdrawn prior to enrollment.
(Time constraints)
Sponsor:
Rush University Medical Center
Information provided by (Responsible Party):
Stephan Munich, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01878136
First received: June 12, 2013
Last updated: November 9, 2015
Last verified: November 2015
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Purpose
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 Hydrocephalus |
Drug: Tissue Plasminogen Activator |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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:
|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01878136
Please refer to this study by its ClinicalTrials.gov identifier: NCT01878136
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
| Responsible Party: | Stephan Munich, Neurosurgery Resident, Rush University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01878136 History of Changes |
| Other Study ID Numbers: | 13011803 |
| Study First Received: | June 12, 2013 |
| Last Updated: | November 9, 2015 |
| Health Authority: | United States: Food and Drug Administration |
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 Tissue Plasminogen Activator Plasminogen Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 30, 2016