Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

Official title:

Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01878136
• Other study ID #: 13011803
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: June 12, 2013
• Last updated: November 9, 2015
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2015
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Aneurysm
• Cerebral Vasospasm
• Hemorrhage
• Hydrocephalus
• Intracranial Aneurysm
• Subarachnoid Hemorrhage

Intervention

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)

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Primary Outcome	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.	1-60 days after SAH	No
Secondary	Rate of new intracranial hemorrhage	New intracranial hemorrhage will be defined as any new parenchymal or ventricular hemorrhage occurring after the first dose of study drug/placebo.	1-14 days after SAH	Yes
Secondary	Rate of intracranial infection	The presence of infection will require identification of an offending organism via CSF cultures.	1-14 after SAH	Yes