Study of Procoagulation Markers in Stroke Patients

Stroke Clinical Trial

— I-SPOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811550
• Other study ID #: 11110979
• Secondary ID: 1U01NS079077-01A
• Status: Completed
• Start date: August 2012
• Est. completion date: January 2019

Study information

• Verified date: April 2020
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: January 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hyperglycemia
• Procoagulation Markers
• Stroke

Intervention

Other:
• Glycemic Control

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Summa Health System	Akron	Ohio
United States	Emory University Hospital	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
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	University of Virginia	Charlottesville	Virginia
United States	University of Cincinnati	Cincinnati	Ohio
United States	Wexner Medical Center	Columbus	Ohio
United States	UT Southwestern-Parkland Memorial Hospital	Dallas	Texas
United States	UT Southwestern-Zale Lipshy University Hospital	Dallas	Texas
United States	Detroit Receiving Hospital	Detroit	Michigan
United States	Sinai-Grace Hospital	Detroit	Michigan
United States	Memorial Hermann Hospital	Houston	Texas
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of Kentucky	Lexington	Kentucky
United States	Long Beach Memorial Hospital	Long Beach	California
United States	Ronald Regan Medical Center	Los Angeles	California
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota
United States	West Virginia University	Morgantown	West Virginia
United States	Columbia University Medical Center	New York	New York
United States	Lincoln Medical and Mental Health Center	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	UPMC - Mercy	Pittsburgh	Pennsylvania
United States	UPMC - Presbyterian	Pittsburgh	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	San Francisco General Hospital	San Francisco	California
United States	Stanford University Medical Center	Stanford	California
United States	Banner University Medical Center	Tucson	Arizona
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (7)

Lead Sponsor	Collaborator
Temple University	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in biomarker between patients with favorable versus unfavorable functional outcome		Randomization, 48 hours and 90 days
Secondary	Changes in biomarker levels between patients with versus without stroke recurrence at 90 days post stroke.		Randomization, 48 hours, 90 days