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

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01827046
Study type	Interventional
Source	Johns Hopkins University
Contact
Status	Completed
Phase	Phase 3
Start date	December 30, 2013
Completion date	September 2018

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms