Study of Procoagulation Markers in Stroke Patients "I-SPOT"

Recruiting

Phase N/A Results N/A

Update History

5 Apr '17
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
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)
Old
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)
30 Sep '16
A location was updated in San Francisco.
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The overall status was updated to "Withdrawn" at UCSF Medical Center.
A location was updated in Peoria.
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The overall status was updated to "Withdrawn" at OSF Saint Francis Medical Center.
A location was updated in Dayton.
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The overall status was updated to "Withdrawn" at Miami Valley Hospital.
4 May '16
The Summary of Purpose was updated.
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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.
Old
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.
The eligibility criteria were updated.
New
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)
Old
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)
26 Aug '15
A location was updated in New York.
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The overall status was updated to "Recruiting" at NYP Weill Cornell Medical Center.
21 Aug '15
A location was updated in Kansas City.
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The overall status was updated to "Withdrawn" at University of Kansas Hospital.
A location was updated in Baltimore.
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The overall status was updated to "Suspended" at University of Maryland Medical Center.
A location was updated in Royal Oak.
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The overall status was updated to "Withdrawn" at William Beaumont Hospital-Royal Oak.
A location was updated in Hackensack.
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The overall status was updated to "Withdrawn" at Hackensack University Medical Center.
A location was updated in Dayton.
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The overall status was updated to "Withdrawn" at Miami Valley Hospital.
A location was updated in Hershey.
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The overall status was updated to "Withdrawn" at Penn State Hershey Medical Center.
A location was updated in Philadelphia.
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The overall status was updated to "Withdrawn" at Jefferson Hospital.
A location was updated in Austin.
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The overall status was updated to "Suspended" at Austin Seton Medical Center.
A location was updated in Austin.
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The overall status was updated to "Suspended" at Austin UMC Brackenridge Hospital.
14 Apr '15
A location was updated in Los Angeles.
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The overall status was updated to "Recruiting" at Ronald Regan Medical Center.
A location was updated in Stanford.
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The overall status was updated to "Recruiting" at Stanford University Medical Center.
A location was updated in Jacksonville.
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The overall status was updated to "Recruiting" at Mayo Clinic Jacksonville.
A location was updated in Atlanta.
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The overall status was updated to "Recruiting" at Grady Memorial Hospital.
A location was updated in Augusta.
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The overall status was updated to "Recruiting" at Georgia Health Sciences University.
A location was updated in Boston.
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The overall status was updated to "Recruiting" at Massachusetts General Hospital.
A location was updated in Detroit.
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The overall status was updated to "Recruiting" at Detroit Receiving Hospital.
A location was updated in Detroit.
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The overall status was updated to "Recruiting" at Sinai-Grace Hospital.
A location was updated in Royal Oak.
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The overall status was updated to "Withdrawn" at William Beaumont Hospital-Royal Oak.
A location was updated in Troy.
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The overall status was updated to "Recruiting" at William Beaumont Hospital-Troy.
A location was updated in Minneapolis.
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The overall status was updated to "Recruiting" at Hennepin County Medical Center.
A location was updated in Minneapolis.
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The overall status was updated to "Recruiting" at University of Minnesota Medical Center, Fairview.
A location was updated in Hackensack.
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The overall status was updated to "Withdrawn" at Hackensack University Medical Center.
A location was updated in Brooklyn.
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The overall status was updated to "Recruiting" at Kings County Hospital.
A location was updated in New York.
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The overall status was updated to "Recruiting" at Columbia University Medical Center.
A location was updated in New York.
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The overall status was updated to "Recruiting" at Lincoln Medical and Mental Health Center.
A location was updated in New York.
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The overall status was updated to "Recruiting" at NYP Weill Cornell Medical Center.
A location was updated in Columbus.
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The overall status was updated to "Recruiting" at Wexner Medical Center.
A location was updated in Abington.
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The overall status was updated to "Recruiting" at Abington Memorial Hospital.
A location was updated in Philadelphia.
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The overall status was updated to "Recruiting" at Hospital of the University of Pennsylvania.
A location was updated in Philadelphia.
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The overall status was updated to "Withdrawn" at Jefferson Hospital.
A location was updated in Pittsburgh.
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The overall status was updated to "Withdrawn" at Allegheny General Hospital.
A location was updated in Dallas.
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The overall status was updated to "Recruiting" at UT Southwestern.
A location was updated in Salt Lake City.
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The overall status was updated to "Recruiting" at University of Utah.
A location was updated in Milwaukee.
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The overall status was updated to "Recruiting" at Froedtert Memorial Lutheran Hospital.
20 Mar '13
A location was updated in Cincinnati.
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The overall status was updated to "Recruiting" at University of Cincinnati.