Study of Procoagulation Markers in Stroke Patients

Completed

Conditions studied: Stroke, Hyperglycemia, Procoagulation Markers

In brief

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.

Key facts

Study ID

NCT01811550

Run by

Temple University

People needed

271

Starts

2012-08-01

Expected to finish

2019-01-01

Last updated by the study team

2020-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrolled in SHINE study
• Ability to give Informed Consent (self or LAR)

You may not qualify if…

• 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)

Where it is running

• Banner University Medical Center — Tucson, Arizona, United States
• Long Beach Memorial Hospital — Long Beach, California, United States
• Ronald Regan Medical Center — Los Angeles, California, United States
• San Francisco General Hospital — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Grady Memorial Hospital — Atlanta, Georgia, 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
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Detroit Receiving Hospital — Detroit, Michigan, United States
• Sinai-Grace Hospital — Detroit, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• University of Minnesota Medical Center, Fairview — Minneapolis, Minnesota, United States
• Kings County Hospital — Brooklyn, New York, United States
• SUNY Downstate University Hospital of Brooklyn — Brooklyn, New York, United States
• Kaleida Stroke Center, SUNY Buffalo — Buffalo, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Lincoln Medical and Mental Health Center — New York, New York, United States
• Summa Health System — Akron, Ohio, United States
• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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