NCT01827046

Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 499 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).

Detailed description

Primary Objectives: Efficacy: Demonstrate that minimally invasive surgery (MIS) plus recombinant tissue plasminogen activator (rt-PA) for three days improves functional outcome by a 12% increase in the modified Rankin Scale (mRS) score 0-3 compared to medically treated subjects assessed at 365 days. Secondary Objective: Demonstrate that the end of treatment volume and percent of ICH reduction from MIS+rt-PA is related to improved functional outcome, as compared to medically treated subjects. Safety: Demonstrate that early use of MIS+rt-PA for three days is safe for the treatment of ICH relative to rates of mortality, rebleeding, and infection in the medically treated subject at 30 days.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
DRUG	rt-PA	Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Timeline

• Start date: 2013-12-30
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2013-04-09
• Last updated: 2019-09-27
• Results posted: 2019-09-27

Locations

84 sites across 9 countries: United States, Australia, Canada, China, Germany, Hungary, Israel, Spain, United Kingdom

Regulatory

• FDA-regulated drug study