Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Rush University Medical Center
Sponsor:
Information provided by (Responsible Party):
Stephan Munich, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01878136
First received: June 12, 2013
Last updated: January 24, 2014
Last verified: January 2014
  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.


Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (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

Placebo

Dose 1 mL sterile saline


  Eligibility

Ages Eligible for Study:   18 Years and older
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Contacts
Contact: Stephan Munich, MD 3129421854 Stephan_Munich@Rush.edu
Contact: Carol MacPherson 3129428614 Carol_MacPherson@Rush.edu

Locations
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Stephan Munich, MD    312-942-1854    Stephan_Munich@Rush.edu   
Contact: Roham Moftakhar, MD    3129421854    Roham_Moftakhar@Rush.edu   
Principal Investigator: Stephan Munich, MD         
Sub-Investigator: Andrew Johnson, MD         
Sub-Investigator: Nicholas Panos, PharmD         
Sub-Investigator: Roham Moftakhar, MD         
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

No publications provided

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: January 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Brain Diseases
Hemorrhage
Hydrocephalus
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension
Intracranial Hemorrhages
Cerebrovascular Disorders
Intracranial Arterial Diseases
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on July 22, 2014