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Thrombolytic Agent

tPA (tissue plaminogen activator) for Brain Aneurysm

Phase 2
Waitlist Available
Led By Andreas Kramer, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

The proposed study is to evaluate the acceleration the clearance of intraventricular blood (IVH) and subarachnoid hemorrhage (SAH) following ruptured intracranial aneurysms, thereby ameliorating complications, such as cerebral vasospasm, hydrocephalus and intracranial hypertension. The primary objectives are: Estimate the rate and variance of hematoma clearance following aneurysmal SAH, thereby facilitating sample size determination for a subsequent larger study; Assess the feasibility of a randomized controlled trial of intraventricular tissue plasminogen activator (TPA) among patients with SAH (enrollment rate, ability to blind investigators, protocol compliance); Confirm the safety of intraventricular TPA.

Eligible Conditions
  • Brain Aneurysm
  • Intraventricular Hemorrhage

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine rate and variance of ventricular and cisternal clot clearance (with and without TPA).
Secondary outcome measures
Assess feasibility of a future multi-center trial
Confirm the safety of intraventricular TPA.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: tPA (tissue plaminogen activator)Active Control1 Intervention
Intraventricular TPA will be administered every 12 hours for a total five doses. Patients will be followed for a total of 6 months.
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered every 12 hours for a total five doses. Patients will be followed for a total of 6 months.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,142 Total Patients Enrolled
Andreas Kramer, MDPrincipal InvestigatorUniversity of Calgary

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Intraventricular Tissue Plasminogen Activator (tPA) in the Management of Aneurysmal Subarachnoid Hemorrhage
2009. "Intraventricular Tissue Plasminogen Activator (tPA) in the Management of Aneurysmal Subarachnoid Hemorrhage". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01098890.
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~1 spots leftby May 2025
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