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

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

Official title: Intraventricular Tissue Plasminogen Activator in the Management of Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Pilot Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Outcome Measures:

Safety will be assessed through adverse events, hemorrhagic complications and the development of ventriculostomy-related infections.

The volume and clearance of intracranial blood will be determined (in ml) using computerized software, as well as validated semi-quantitative ordinal scales (SAH Sum Score, Modified Graeb Score). The amount of IVH and SAH will be assessed at baseline (day 0), 72 hours after treatment onset, and on post-SAH day 8.

Additional secondary outcomes will include:

1. The occurrence of vasospasm, as determined using transcranial Doppler ultrasonography

2. The occurrence of radiographic vasospasm, using CT angiography.

3. The occurrence of "clinical" (symptomatic) vasospasm

4. The rate of catheter-related central nervous system infections

5. Levels of cytokines, endothelin and matrix metalloproteases in cerebrospinal fluid (CSF) and plasma

6. Levels of fibrin-derived products (FDP), TPA and plasminogen-activator inhibitor in CSF

7. Levels of S100β and neuron-specific enolase (NSE) in CSF and serum

8. Intracranial pressure

9. Volume of CSF drainage

10. Extended Glasgow Outcome Scale, modified Rankin scale, EuroQOL at 6 months post-SAH

11. Duration that ventriculostomy is required; need for permanent shunt

12. Fever burden ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Cerebral Hemorrhage
• Hemorrhage
• Intraventricular Hemorrhage
• Subarachnoid Hemorrhage

• NCT number: NCT01098890
• Study type: Interventional
• Source: University of Calgary
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2009
• Completion date: April 2012