Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage

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Brief Title

Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage

Official Title

Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage

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.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Composite Primary Outcome

Secondary Outcome

 Rate of new intracranial hemorrhage

Condition

Subarachnoid Hemorrhage

Intervention

Tissue Plasminogen Activator

Study Arms / Comparison Groups

 Intraventricular tPA
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

March 2015

Completion Date

September 2016

Primary Completion Date

September 2016

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Stephan Munich, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01878136

Organization ID

13011803


Responsible Party

Principal Investigator

Study Sponsor

Rush University Medical Center


Study Sponsor

Stephan Munich, MD, Principal Investigator, Rush University Medical Center, Department of Neurosurgery


Verification Date

November 2015