NCT01098890

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Aneurysmal Subarachnoid Hemorrhage
• Intraventricular Hemorrhage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-10-01
• Completion: 2012-04-01
• First posted: 2010-04-05
• Last updated: 2010-11-11

Locations

1 site across 1 country: Canada