MedTrace Logo

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

NCT01827046 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 499

Last updated 2019-09-27

Study results available
· View outcomes & findings →

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).

Conditions

  • Intracerebral Hemorrhage

Interventions

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.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Genentech, Inc.

    collaborator INDUSTRY

  • Emissary International LLC

    collaborator INDUSTRY

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Daniel F. Hanley, MD · Johns Hopkins University

  • Mario Zuccarello, MD · University of Cincinnati

  • Issam Awad, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-30
Primary Completion
2018-09-30
Completion
2018-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • Germany
  • Hungary
  • Israel
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01827046 on ClinicalTrials.gov