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Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke

NCT00283088 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2011-01-12

No results posted yet for this study

Summary

The purpose of this trial is to evaluate if it is safe to use tissue plasminogen activator (tPA) within 6 hours of stroke onset when combined with hypothermia.

Conditions

Interventions

PROCEDURE

hypothermia

Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System. Subjects are stratified by time to six groups.

DRUG

tissue plasminogen activator

tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots

Sponsors & Collaborators

Principal Investigators

  • Patrick Lyden, MD · University of California San Diego, Stroke Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2008-10-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT00283088 on ClinicalTrials.gov