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



Status:Recruiting
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:22 - 82
Updated:2/7/2015
Start Date:June 2010
End Date:April 2017
Contact:Patrick D. Lyden, MD
Email:patrick.lyden@cshs.org
Phone:310-423-5166

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Phase 2/3 Study of Intravenous Thrombolysis and Hypothermia for Acute Treatment of Ischemic Stroke

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.

A stroke is usually caused by a blockage in one of the arteries that carries blood to the
brain. Research has shown that tissue plasminogen activator (tPA)—a naturally occurring
protein that opens blocked arteries by dissolving blood clots — activates the body's ability
to dissolve recently formed blood clots and reduces or prevents the brain damage caused by a
stroke.

The Food and Drug Administration (FDA) has approved the use of tPA for people having a
stroke when taken within 3 hours of stroke onset.

Researchers believe that a lower body temperature (hypothermia) may be beneficial while a
stroke is happening because hypothermia may prevent further brain injury, or may make the
stroke less damaging.

Patients will receive a standard stroke evaluation, which includes blood tests, a computed
tomography (CT) scan, complete physical and neurological examinations, and an
electrocardiogram (EKG) to determine eligibility for the study.

There are two study groups - tPA alone or tPA with cooling (hypothermia). Participants will
be randomly assigned to one of the two study groups. Length of participation (including
observation after the patient leaves the hospital) is 90 days.

This study is part of the Specialized Program of Translational Research in Acute Stroke
(SPOTRIAS), which allows researchers to enhance and initiate translational research that
ultimately will benefit stroke patients by treating more patients in less than 2 hours, and
finding ways to treat additional patients later.

Inclusion Criteria:

1. Age 22 to 82 years old inclusive

2. Patient receiving IV rt-PA using standard guidelines (Appendix II) Page 23

3. NIHSS score ≥ 7 and ≤ 20 (right hemisphere) or ≥ 7 and ≤ 24 (left hemisphere) at the
time of randomization

4. Pre-stroke mRS 0-1

5. Able to begin endovascular phase of hypothermia within 2 hours of tPA completion

6. Written Informed Consent, signed and dated by the patient (or patient's authorized
representative)

Exclusion Criteria:

1. Etiology other than ischemic stroke

2. Item 1a on NIHSS > 1 at the time of randomization

3. Clinical symptoms consistent with brainstem or cerebellar stroke

4. 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

5. 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

6. 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

7. Pregnancy (All women of child-bearing potential must have a negative pregnancy test,
urine or blood, prior to therapy.)

8. Medical conditions likely to interfere with patient assessment.

9. Known allergy to meperidine or buspirone

10. Currently taking or used within previous 14 days MAO-I class of medication.

11. Life expectancy < 6 months

12. Not likely to be available for long-term follow-up

13. Use, or planned use, of intra-arterial thrombolysis, mechanical clot removal, or
other experimental or approved acute therapy for this stroke event

14. Chest radiograph or clinical presentation suggestive of pneumonia at baseline.

15. Temperature upon admission greater than or equal to 38°C
We found this trial at
14
sites
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Sarasota, Florida 34232
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Abington, PA
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Austin, Texas 78705
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Des Moines, Iowa 50314
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East Lansing, Michigan 48824
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Elk Grove Village, Illinois 60007
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Robbinsdale, Minnesota 55422
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San Diego, California 92103
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San Diego, California 92103
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