The Intravascular Cooling in the Treatment of Stroke 2/3 Trial
NCT ID: NCT01123161
Last Updated: 2017-04-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2010-06-30
2015-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Group1: IV t-PA and normothermia
IV tpa and normothermia
Group1: IV t-PA and normothermia
Group 1 will t-PA as standard of care and normothermia
Group 2 : IV t-PA and hypothermia and anti-shivering treatment
IV tpa and hypothermia and anti-shivering treatment
hypothermia and anti-shivering treatment
Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming
Interventions
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hypothermia and anti-shivering treatment
Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming
Group1: IV t-PA and normothermia
Group 1 will t-PA as standard of care and normothermia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient receiving IV rt-PA using standard guidelines
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
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 x. History of HIT (heparin induced thrombocytopenia)
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 or clinically significant pulmonary edema at baseline.
15. Temperature upon admission greater than or equal to 38°C
22 Years
82 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
The University of Texas Health Science Center, Houston
OTHER
University of California, San Diego
OTHER
Responsible Party
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Patrick Lyden
Principal Investigator
Principal Investigators
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Patrick D. Lyden, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Thomas M. Hemmen, MD, PhD
Role: STUDY_DIRECTOR
University of California, San Diego
James C. Grotta, MD
Role: STUDY_DIRECTOR
The University of Texas Health Science Center, Houston
Locations
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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
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Seton Medical Center Austin
Austin, Texas, United States
UT Southwestern
Dallas, Texas, United States
University of Texas Health Science Center
Houston, Texas, United States
Medical University Innsbruck
Innsbruck, , Austria
CHUV
Lausanne, , Switzerland
Countries
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References
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Lyden PD, Allgren RL, Ng K, Akins P, Meyer B, Al-Sanani F, Lutsep H, Dobak J, Matsubara BS, Zivin J. Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience. J Stroke Cerebrovasc Dis. 2005 May-Jun;14(3):107-14. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001.
Hemmen TM, Raman R, Guluma KZ, Meyer BC, Gomes JA, Cruz-Flores S, Wijman CA, Rapp KS, Grotta JC, Lyden PD; ICTuS-L Investigators. Intravenous thrombolysis plus hypothermia for acute treatment of ischemic stroke (ICTuS-L): final results. Stroke. 2010 Oct;41(10):2265-70. doi: 10.1161/STROKEAHA.110.592295. Epub 2010 Aug 19.
Lyden P, Ernstrom K, Raman R. Determinants of Pneumonia Risk During Endovascular Hypothermia. Ther Hypothermia Temp Manag. 2013 Mar;3(1):24-27. doi: 10.1089/ther.2012.0021.
Lyden P, Ernstrom K, Cruz-Flores S, Gomes J, Grotta J, Mullin A, Rapp K, Raman R, Wijman C, Hemmen T. Determinants of effective cooling during endovascular hypothermia. Neurocrit Care. 2012 Jun;16(3):413-20. doi: 10.1007/s12028-012-9688-y.
Guluma KZ, Liu L, Hemmen TM, Acharya AB, Rapp KS, Raman R, Lyden PD. Therapeutic hypothermia is associated with a decrease in urine output in acute stroke patients. Resuscitation. 2010 Dec;81(12):1642-7. doi: 10.1016/j.resuscitation.2010.08.003.
Guluma KZ, Hemmen TM, Olsen SE, Rapp KS, Lyden PD. A trial of therapeutic hypothermia via endovascular approach in awake patients with acute ischemic stroke: methodology. Acad Emerg Med. 2006 Aug;13(8):820-7. doi: 10.1197/j.aem.2006.03.559. Epub 2006 Jun 9.
Lyden P, Hemmen T, Grotta J, Rapp K, Ernstrom K, Rzesiewicz T, Parker S, Concha M, Hussain S, Agarwal S, Meyer B, Jurf J, Altafullah I, Raman R; Collaborators. Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2). Stroke. 2016 Dec;47(12):2888-2895. doi: 10.1161/STROKEAHA.116.014200. Epub 2016 Nov 10.
Other Identifiers
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