NCT00650858

Clinical Trial on Treatment of Intraventricular Hemorrhage

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.

Detailed description

The purpose of this trial is to determine the efficacy and pharmacokinetics of intraventricular injections of multiple low doses of rt-PA. Sixteen subjects were already randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to 8 doses. Results of this stage (n=16) were then analyzed and the most effective dose of 1.0 mg was chosen to be used in the second stage (n=36) to determine the optimal frequency of dosing. We propose to test if this intervention facilitates more rapid clot resolution, complete recovery function and decreased mortality from this condition.

Conditions

• Intraventricular Hemorrhage

Interventions

Type	Name	Description
DRUG	tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)	0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.

Timeline

• Start date: 2004-02-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-04-02
• Last updated: 2017-12-11
• Results posted: 2012-07-17

Locations

25 sites across 4 countries: United States, Canada, Germany, United Kingdom