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I-SPOT: Study of Procoagulation Markers in Stroke Patients

Sponsor
Temple University (Other)
Overall Status
Completed
CT.gov ID
NCT01811550
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH), Neurological Emergencies Treatment Trials Network (NETT) (Other), University of Virginia (Other), University of Michigan (Other), Medical University of South Carolina (Other), Augusta University (Other)
271
Enrollment
38
Locations
77
Duration (Months)
7.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Glycemic Control

Study Design

Study Type:
Observational
Actual Enrollment :
271 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT)
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
SHINE study subjects

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.

Other: Glycemic Control
Other Names:
  • Blood draw at 0 and 48 hours
  • Glycemic Control per SHINE protocol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change in biomarker between patients with favorable versus unfavorable functional outcome [Randomization, 48 hours and 90 days]

    Secondary Outcome Measures

    1. Changes in biomarker levels between patients with versus without stroke recurrence at 90 days post stroke. [Randomization, 48 hours, 90 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner University Medical Center Tucson Arizona United States 85724
    2 Long Beach Memorial Hospital Long Beach California United States 90806
    3 Ronald Regan Medical Center Los Angeles California United States 90095
    4 San Francisco General Hospital San Francisco California United States 94110
    5 Stanford University Medical Center Stanford California United States 94305
    6 Medstar Washington Hospital Center Washington District of Columbia United States 20010
    7 Mayo Clinic Jacksonville Jacksonville Florida United States 32224
    8 Emory University Hospital Atlanta Georgia United States 30322
    9 Grady Memorial Hospital Atlanta Georgia United States 30322
    10 Augusta University Augusta Georgia United States 30912
    11 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242
    12 University of Kentucky Lexington Kentucky United States 40506
    13 Massachusetts General Hospital Boston Massachusetts United States 02114
    14 Detroit Receiving Hospital Detroit Michigan United States 48201
    15 Sinai-Grace Hospital Detroit Michigan United States 48235
    16 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    17 University of Minnesota Medical Center, Fairview Minneapolis Minnesota United States 55455
    18 Kings County Hospital Brooklyn New York United States 11203
    19 SUNY Downstate University Hospital of Brooklyn Brooklyn New York United States 11203
    20 Kaleida Stroke Center, SUNY Buffalo Buffalo New York United States 14210
    21 Mount Sinai Medical Center New York New York United States 10029
    22 Columbia University Medical Center New York New York United States 10032
    23 Lincoln Medical and Mental Health Center New York New York United States 10451
    24 Summa Health System Akron Ohio United States 44304
    25 University of Cincinnati Cincinnati Ohio United States 45221
    26 Wexner Medical Center Columbus Ohio United States 43210
    27 Abington Memorial Hospital Abington Pennsylvania United States 19001
    28 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    29 Temple University Hospital Philadelphia Pennsylvania United States 19140
    30 UPMC - Mercy Pittsburgh Pennsylvania United States 15219
    31 UPMC - Presbyterian Pittsburgh Pennsylvania United States 15261
    32 UT Southwestern-Parkland Memorial Hospital Dallas Texas United States 75390
    33 UT Southwestern-Zale Lipshy University Hospital Dallas Texas United States 75390
    34 Memorial Hermann Hospital Houston Texas United States 77030
    35 University of Utah Salt Lake City Utah United States 84132
    36 University of Virginia Charlottesville Virginia United States 22908
    37 West Virginia University Morgantown West Virginia United States 26506
    38 Froedtert Memorial Lutheran Hospital Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Nina T Gentile, M.D., Temple University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Temple University
    ClinicalTrials.gov Identifier:
    NCT01811550
    Other Study ID Numbers:
    • 11110979
    • 1U01NS079077-01A1
    First Posted:
    Mar 14, 2013
    Last Update Posted:
    Apr 30, 2020
    Last Verified:
    Apr 1, 2020
    Additional relevant MeSH terms:
    Stroke
    Hyperglycemia

    Study Results

    No Results Posted as of Apr 30, 2020