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

Stopped early · Phase 2/Phase 3

Conditions studied: Stroke, Acute

In brief

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.

Key facts

Study ID

NCT01123161

Run by

University of California, San Diego

People needed

120

Starts

2010-06-01

Expected to finish

2015-05-01

Last updated by the study team

2017-04-05

Who can join

Age: 22 and older, up to 82. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 22 to 82 years old inclusive
• Patient receiving IV rt-PA using standard guidelines
• NIHSS score ≥ 7 and ≤ 20 (right hemisphere) or ≥ 7 and ≤ 24 (left hemisphere) at the time of randomization
• Pre-stroke mRS 0-1
• Able to begin endovascular phase of hypothermia within 2 hours of tPA completion
• Written Informed Consent, signed and dated by the patient (or patient's authorized representative)

You may not qualify if…

• Etiology other than ischemic stroke
• Item 1a on NIHSS > 1 at the time of randomization
• Clinical symptoms consistent with brainstem or cerebellar stroke
• Classic lacunar syndrome with imaging confirmation of small deep ischemia, but randomization will not be delayed for neuroimaging other than initial scan to exclude hemorrhage
• Known contraindications to hypothermia, such as known hematologic dyscrasias that affect thrombosis (cryoglobulinemia, Sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thromboangiitis obliterans
• Known co-morbid conditions that are likely to complicate therapy in the opinion of the investigator, e.g., i. Heart failure (NYHA class III and IV)* ii. Uncompensated arrhythmia iii. Severe Liver disease iv. History of pelvic or abdominal mass likely to compress inferior vena cava v. IVC filters vi. HIV positive vii. Clinically active hypo or hyperthyroidism viii. Renal insufficiency likely to impair meperidine clearance ix. Chronic ethanol abuse x. History of HIT (heparin induced thrombocytopenia)
• Pregnancy (All women of child-bearing potential must have a negative pregnancy test, urine or blood, prior to therapy.)
• Medical conditions likely to interfere with patient assessment.
• Known allergy to meperidine or buspirone
• Currently taking or used within previous 14 days MAO-I class of medication.
• Life expectancy < 6 months
• Not likely to be available for long-term follow-up
• Use, or planned use, of intra-arterial thrombolysis, mechanical clot removal, or other experimental or approved acute therapy for this stroke event
• Chest radiograph or clinical presentation suggestive of pneumonia or clinically significant pulmonary edema at baseline.
• Temperature upon admission greater than or equal to 38°C

Where it is running

• University of Alabama Hospital — Birmingham, Alabama, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• University of California San Diego Health System — San Diego, California, United States
• Scripps Mercy Medical Center — San Diego, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Gulf Coast Medical Center — Fort Myers, Florida, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami, Jackson Memorial Hospital — Miami, Florida, United States
• Intercoastal Medical Group — Sarasota, Florida, United States
• St. Joseph's Hospital — Tampa, Florida, United States
• Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States
• Parkview Hospital — Fort Wayne, Indiana, United States
• Ruan Neurology Clinic and Research Center — Des Moines, Iowa, United States
• University of Louisville — Louisville, Kentucky, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Michigan State University — East Lansing, Michigan, United States
• North Memorial Medical Center — Robbinsdale, Minnesota, United States
• Saint Louis University Medical Center — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• University of Toledo Medical Center — Toledo, Ohio, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States

Full record on ClinicalTrials.gov

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