Study of Procoagulation Markers in Stroke Patients
- Conditions
- HyperglycemiaProcoagulation MarkersStroke
- Interventions
- Other: Glycemic Control
- Registration Number
- NCT01811550
- Lead Sponsor
- Temple University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 271
- Enrolled in SHINE study
- Ability to give Informed Consent (self or LAR)
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SHINE study subjects Glycemic Control Subjects enrolled in the SHINE trial who are not receiving intra-arterial therapy nor systemic anticoagulation; have no known moderate/severe hepatic insufficiency; have no known history of hypercoaguable or thrombotic condition; have INR =\<1.5 (if known) at baseline and provide informed consent (self or LAR) will be enrolled in the I-SPOT study.
- Primary Outcome Measures
Name Time Method change in biomarker between patients with favorable versus unfavorable functional outcome Randomization, 48 hours and 90 days
- Secondary Outcome Measures
Name Time Method Changes in biomarker levels between patients with versus without stroke recurrence at 90 days post stroke. Randomization, 48 hours, 90 days
Trial Locations
- Locations (38)
Ronald Regan Medical Center
🇺🇸Los Angeles, California, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Wexner Medical Center
🇺🇸Columbus, Ohio, United States
UT Southwestern-Parkland Memorial Hospital
🇺🇸Dallas, Texas, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
UPMC - Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Medical Center, Fairview
🇺🇸Minneapolis, Minnesota, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
UT Southwestern-Zale Lipshy University Hospital
🇺🇸Dallas, Texas, United States
Banner University Medical Center
🇺🇸Tucson, Arizona, United States
Long Beach Memorial Hospital
🇺🇸Long Beach, California, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
UPMC - Mercy
🇺🇸Pittsburgh, Pennsylvania, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Kings County Hospital
🇺🇸Brooklyn, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Lincoln Medical and Mental Health Center
🇺🇸New York, New York, United States
Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Summa Health System
🇺🇸Akron, Ohio, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Kaleida Stroke Center, SUNY Buffalo
🇺🇸Buffalo, New York, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
SUNY Downstate University Hospital of Brooklyn
🇺🇸Brooklyn, New York, United States
Sinai-Grace Hospital
🇺🇸Detroit, Michigan, United States
San Francisco General Hospital
🇺🇸San Francisco, California, United States
Detroit Receiving Hospital
🇺🇸Detroit, Michigan, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Froedtert Memorial Lutheran Hospital
🇺🇸Milwaukee, Wisconsin, United States