Clinical trial NCT01811550: Study of Procoagulation Markers in Stroke Patients
Official title: Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Hyperglycemia
Procoagulation Markers
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Neurological Emergencies Treatment Trials Network (NETT)
name: University of Virginia
name: University of Michigan
name: Medical University of South Carolina
name: Augusta University
First posted: 2013-03-14
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected from participants in the SHINE trial.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: change in biomarker between patients with favorable versus unfavorable functional outcome
timeFrame: Randomization, 48 hours and 90 days
Secondary outcomes:
measure: Changes in biomarker levels between patients with versus without stroke recurrence at 90 days post stroke.
timeFrame: Randomization, 48 hours, 90 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
city: Long Beach
country: United States
facility: Long Beach Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: Ronald Regan Medical Center
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
city: Detroit
country: United States
facility: Sinai-Grace Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Fairview
state: Minnesota
city: Brooklyn
country: United States
facility: Kings County Hospital
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate University Hospital of Brooklyn
state: New York
city: Buffalo
country: United States
facility: Kaleida Stroke Center, SUNY Buffalo
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Lincoln Medical and Mental Health Center
state: New York
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Wexner Medical Center
state: Ohio
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC - Mercy
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC - Presbyterian
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern-Parkland Memorial Hospital
state: Texas
city: Dallas
country: United States
facility: UT Southwestern-Zale Lipshy University Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
Study officials:
affiliation: Temple University
name: Nina T Gentile, M.D.
role: PRINCIPAL_INVESTIGATOR
References: