Study of Procoagulation Markers in Stroke Patients



Status:Active, not recruiting
Conditions:Neurology, Diabetes
Therapuetic Areas:Endocrinology, Neurology
Healthy:No
Age Range:18 - Any
Updated:12/15/2018
Start Date:August 2012
End Date:November 2019

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Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT)

The Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT):
Response to Insulin Administration and Blood Glucose Control proposal is designed to
accompany the Stroke Hyperglycemia Insulin Network Effort (SHINE) clinical trial, a Phase III
multicenter, randomized, controlled trial planning to determine the efficacy and validate the
safety of glycemic control in stroke patients. The SHINE trial will recruit 1,400 AIS
patients with Type II diabetes mellitus (T2DM) and hyperglycemia, each receiving 3 days of
hyperglycemia control with intravenous (IV) insulin therapy or control therapy with
subcutaneous (SQ) insulin. The I-SPOT trial will recruit 315 SHINE patients. Blood
coagulation marker levels will be measured before and at 48 hours after the start of
treatment. Baseline and temporal changes in biomarkers levels will be compared between
treatment groups.

Hypothesis: The decrease in levels of markers of blood coagulation will be greater in
patients treated with IV insulin to reduce BG than in patients treated with SQ Insulin as the
standard fashion.

Hypothesis: The decrease in levels of markers of blood coagulation will be greater in
patients with than without favorable (SHINE) outcome (defined as the baseline stroke severity
adjusted measure of functional ability at 90 days after AIS).

Hypothesis: Hyperglycemia control modulates the relationship between blood coagulation levels
and functional outcome in T2DM patients after stroke. Patients treated with IV Insulin for
hyperglycemia control with favorable (SHINE) outcome will have greater decreases in blood
coagulation levels than either IV Insulin-treated patients without favorable outcome or SQ
Insulin-treated with or without favorable outcomes at 90 days after AIS.


Inclusion Criteria:

- Enrolled in SHINE study

- Ability to give Informed Consent (self or LAR)

Exclusion Criteria:

- Current or planned use of full dose anticoagulation from baseline to the 48 hour
sample collection

- Known moderate or severe hepatic insufficiency (as defined by INR>1.5 if known or
history of variceal bleeding or hepatic encephalopathy)

- Prior or concurrent thrombotic or hypercoagulable condition (Antiphospholipid antibody
syndrome; Antithrombin III, Protein C or S deficiencies; Congenital or Inherited
Factor deficiencies; sickle cell disease)
We found this trial at
38
sites
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Principal Investigator: Karen Hirsch, MD
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Christopher Anderson, MD
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6071 West Outer Drive
Detroit, Michigan 48235
Principal Investigator: Claire Pearson, MD
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: Neha Dangayach, MD
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Brett Cucchiara, MD
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Jana Wold, MD
University of Utah Research is a major component in the life of the U benefiting...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Principal Investigator: David Weisman, MD
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Akron, Ohio 44304
Principal Investigator: Susana Bowling, MD
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Vishal Patel, MD
Emory University Hospital As the largest health care system in Georgia and the only health...
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Principal Investigator: Vishal Patel, MD
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Augusta, Georgia 30912
Principal Investigator: Askiel Bruno, MD
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Brooklyn, New York 11203
Principal Investigator: Jennifer Martindale, MD
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Brooklyn, New York 11203
Principal Investigator: Steven Levine, MD
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Buffalo, New York 14210
Principal Investigator: Marilou Ching, MD
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Karen Johnston, MD, MSc
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Opeolu Adeoye, MD
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Columbus, Ohio 43210
Principal Investigator: Michel Torbey, MD
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Dallas, Texas 75390
Principal Investigator: Christiana Hall, MD, MS
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Dallas, Texas 75390
Principal Investigator: Christiana Hall, MD, MS
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Detroit, Michigan 48202
Principal Investigator: Claire Pearson, MD
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Houston, Texas 77030
Principal Investigator: Elizabeth Jones, MD
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Enrique Liera, MD
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jacksonville, Florida 32216
Principal Investigator: Kevin Barrett, MD
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Roger Humphries, MD
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Long Beach, California 90801
Principal Investigator: Nima Ramezan, MD
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Los Angeles, California 90095
Principal Investigator: Sidney Starkman, MD
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Milwaukee, Wisconsin 53226
Principal Investigator: John Lynch, MD
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Minneapolis, Minnesota 55414
Principal Investigator: Mustapha Ezzeddine, MD
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2450 Riverside Ave
Minneapolis, Minnesota 55454
(612) 273-3000
Principal Investigator: Mustapha Ezzeddine, MD
University of Minnesota Medical Center, Fairview Improving patients' lives drives the innovation that makes University...
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Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: John Brick, MD
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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New York, New York 10451
Principal Investigator: Steven Levine, MD
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Jan Claassen, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: Nina T Gentile, M.D.
Phone: 215-707-5483
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Pittsburgh, Pennsylvania 15219
Principal Investigator: Lori Shutter, MD
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Lori Shutter, MD
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1001 Potrero Ave
San Francisco, California 94110
(415) 206-8000
Principal Investigator: Claude Hemphill, MD
San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
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Tucson, Arizona 85742
Principal Investigator: Kendra Drake, MD
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Washington, District of Columbia
Principal Investigator: Richard Benson, MD
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