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The Intravascular Cooling in the Treatment of Stroke 2/3 Trial

NCT01123161 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-04-05

Study results available
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Summary

The purpose of this trial is to determine whether the combination of thrombolysis and hypothermia is superior to thrombolysis alone for the treatment of acute ischemic stroke.

Conditions

  • Stroke, Acute

Interventions

DEVICE

hypothermia and anti-shivering treatment

Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming

DRUG

Group1: IV t-PA and normothermia

Group 1 will t-PA as standard of care and normothermia

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • University of California, San Diego

    lead OTHER

Principal Investigators

  • Patrick D. Lyden, MD · Cedars-Sinai Medical Center

  • Thomas M. Hemmen, MD, PhD · University of California, San Diego

  • James C. Grotta, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
22 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2015-01-31
Completion
2015-05-31

Countries

  • United States
  • Austria
  • Switzerland

Study Locations

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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 NCT01123161 on ClinicalTrials.gov