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Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation

NCT00224770 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2015-06-18

Study results available
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Summary

The purpose of this trial is to determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The ICES arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE intention to treat subjects represent the hypothesized test group. The ICES cohort is to be analyzed separately.

Conditions

  • Intracerebral Hemorrhage

Interventions

DRUG

MIS+Cathflo Activase (drug)

MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.

PROCEDURE

Intraoperative stereotactic CT-Guided Endoscopic Surgery

Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting arm as MISTIE arm. No rt-PA administered, and in addition to best medical care.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Genentech, Inc.

    collaborator INDUSTRY

  • Emissary International LLC

    collaborator INDUSTRY

  • Daniel Hanley

    lead OTHER

Principal Investigators

  • Daniel F. Hanley, MD · Johns Hopkins University

  • Mario Zuccarello, MD · University of Cincinnati

  • Paul Vespa, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2012-08-31
Completion
2013-04-30

Countries

  • United States
  • Canada
  • Germany
  • United Kingdom

Study Locations

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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 NCT00224770 on ClinicalTrials.gov