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Intraventricular Tissue Plasminogen Activator (tPA) in the Management of Aneurysmal Subarachnoid Hemorrhage

NCT01098890 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2010-11-11

No results posted yet for this 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:

1. Estimate the rate and variance of hematoma clearance following aneurysmal SAH, thereby facilitating sample size determination for a subsequent larger study;
2. 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);
3. Confirm the safety of intraventricular TPA.

Conditions

  • Aneurysmal Subarachnoid Hemorrhage
  • Intraventricular Hemorrhage

Interventions

DRUG

Tissue Plasminogen Activator

2mg tPA will be given every twelve hours for a maximum of 5 doses

DRUG

Placebo

Placebo will be administered every 12 hours for a maximum of 5 doses.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Andreas Kramer, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-10-31
Completion
2012-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01098890 on ClinicalTrials.gov