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Study of Procoagulation Markers in Stroke Patients (I-SPOT)

This study is currently recruiting participants.
Verified February 2013 by Temple University
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
SHINE Trial
Neurological Emergencies Treatment Trials Network (NETT)
University of Virginia
University of Michigan
Medical University of South Carolina
Georgia Regents University
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT01811550
First received: March 12, 2013
Last updated: March 18, 2013
Last verified: February 2013
History of Changes

March 12, 2013
March 18, 2013
August 2012
August 2017   (final data collection date for primary outcome measure)
change in biomarker between patients with favorable versus unfavorable functional outcome [ Time Frame: Randomization, 48 hours and 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01811550 on ClinicalTrials.gov Archive Site
Changes in biomarker levels between patients with versus without stroke recurrence at 90 days post stroke. [ Time Frame: Randomization, 48 hours, 90 days ] [ Designated as safety issue: No ]
Same as current
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Not Provided
 
Study of Procoagulation Markers in Stroke Patients
Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT)

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood and plasma
Non-Probability Sample

Subjects will be selected from subjects participating in the SHINE trial.
  • Stroke
  • Hyperglycemia
  • Procoagulation Markers
Other: Glycemic Control
Other Names:
  • Blood draw at 0 and 48 hours
  • Glycemic Control per SHINE protocol
SHINE study subjects
Subjects enrolled in the SHINE trial who are not recieving thrombolytics 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.
Intervention: Other: Glycemic Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
315
Not Provided
August 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Current or anticipated use of systemic anticoagulants or thrombolytics
  • 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)
Both
18 Years and older
No
Contact: Hannah Reimer, RN, BSN 215-707-5483 hreimer@temple.edu
United States
 
NCT01811550
11110979, 1U01NS079077-01A1
Yes
Temple University
Temple University
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • SHINE Trial
  • Neurological Emergencies Treatment Trials Network (NETT)
  • University of Virginia
  • University of Michigan
  • Medical University of South Carolina
  • Georgia Regents University
Principal Investigator: Nina T Gentile, M.D. Temple University
Temple University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP