Study of Procoagulation Markers in Stroke Patients

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Procoagulation Markers Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner University Medical Center, Tucson, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Glycemic Control

Other

Other names: Blood draw at 0 and 48 hours, Glycemic Control per SHINE protocol

Primary outcomes

change in biomarker between patients with favorable versus unfavorable functional outcome

Time frame: Randomization, 48 hours and 90 days

Secondary outcomes

Changes in biomarker levels between patients with versus without stroke recurrence at 90 days post stroke.

Time frame: Randomization, 48 hours, 90 days

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

Augusta University
Medical University of South Carolina
National Institute of Neurological Disorders and Stroke (NINDS)
Neurological Emergencies Treatment Trials Network (NETT)
University of Michigan
University of Virginia

Registry information

Official study title

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

Acronym: I-SPOT

Important dates

Study start: 2012
Primary completion: 2018
Study completion: 2019
First posted: Mar 14, 2013
Registry last updated: Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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