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

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ClinicalTrials.gov Identifier: NCT01811550
Recruitment Status : Active, not recruiting
First Posted : March 14, 2013
Last Update Posted : December 13, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Temple University

Tracking Information
First Submitted Date March 12, 2013
First Posted Date March 14, 2013
Last Update Posted Date December 13, 2018
Study Start Date August 2012
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2013)
change in biomarker between patients with favorable versus unfavorable functional outcome [ Time Frame: Randomization, 48 hours and 90 days ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01811550 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 12, 2013)
Changes in biomarker levels between patients with versus without stroke recurrence at 90 days post stroke. [ Time Frame: Randomization, 48 hours, 90 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Procoagulation Markers in Stroke Patients
Official Title Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood and plasma
Sampling Method Non-Probability Sample
Study Population Subjects will be selected from participants in the SHINE trial.
Condition
  • Stroke
  • Hyperglycemia
  • Procoagulation Markers
Intervention Other: Glycemic Control
Other Names:
  • Blood draw at 0 and 48 hours
  • Glycemic Control per SHINE protocol
Study Groups/Cohorts 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.
Intervention: Other: Glycemic Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 12, 2013)
315
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01811550
Other Study ID Numbers 11110979
1U01NS079077-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Temple University
Study Sponsor Temple University
Collaborators
  • 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
PRS Account Temple University
Verification Date December 2018