Recruiting
Phase 2

tPA

Sponsor:

University of Calgary

Code:

NCT01098890

Conditions

Aneurysmal Subarachnoid Hemorrhage

Intraventricular Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tissue Plasminogen Activator

Placebo

Study Details

Brief 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

Study ID

NCT01098890

Start date

Oct, 2009

Status verified date

Apr, 2010

Completion date

Apr, 2012

Anticipated

Primary completion date

Oct, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients (> 18 years old) with a proven ruptured cerebral aneurysm
  • Aneurysm has been / will be treated with coil embolization
  • EVD has been / will be placed as part of routine care
  • Modified Fisher score is 4 (cisternal blood > 1 mm thick with concomitant IVH)
  • CT scan after EVD placement shows "stability" with no increase in the amount of intracranial blood (Note: there is sometimes layering of blood, especially in the occipital horns of the lateral ventricles, that develops during the first 24-48 hours after a ruptured aneurysm due to circulation of blood in the CSF - this does not necessarily constitute an exclusion criterion).
  • Study drug can be administered within 72 hours of the time of SAH.

Exclusion Criteria:

  • Concern expressed by endovascular neurosurgeon / interventional radiologist that aneurysm has only been incompletely treated / isolated by coil embolization.
  • Patient requires craniotomy and clipping of the culprit aneurysm.
  • CT scan performed post-EVD insertion OR post-coiling shows increase in amount of intracranial blood.
  • Uncorrected coagulation disturbance (INR > 1.5, PTT > 45); correction is permitted (if coagulation disturbance develops during the study, subsequent doses of TPA should simply be withheld until coagulation can be corrected).
  • Uncorrected thrombocytopenia (platelets < 50,000); correction with platelet transfusions is permitted.
  • Involvement in another clinical trial
  • Uncontrolled active internal hemorrhage
  • Known allergy to study drug
  • Patient is pregnant
  • Any other condition the investigator believes would place the subject at risk if included in the study.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo will be administered every 12 hours for a total five doses. Patients will be followed for a total of 6 months.

active comparator: tPA (tissue plaminogen activator)

Intraventricular TPA will be administered every 12 hours for a total five doses. Patients will be followed for a total of 6 months.

Interventions

Tissue Plasminogen Activator

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

Placebo

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

Primary outcome measure

  • Determine rate and variance of ventricular and cisternal clot clearance (with and without TPA). [ Time Frame: 8 Days post bleed ]

Central Contacts and Locations

Locations

Foothills Medical Center

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Andreas Kramer, M.D

403-944-4749andreas.kramer@albertahealthservices.ca

Stephanie Todd, BSc. MBT, CCRP

403-944-3414stephanie.todd@albertahealthservices.ca

Principal Investigator:

Andreas Kramer, MD

More Information

Sponsor

University of Calgary

Last update posted

Nov 11, 2010

Last verified

Apr, 2010

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2010-11-11.