Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study

• ClinicalTrials.gov Identifier: NCT00373269
• Recruitment Status: Completed
• First Posted: September 8, 2006
• Results First Posted: January 4, 2017
• Last Update Posted: February 27, 2017
• Sponsor: Temple University
• Information provided by (Responsible Party): Temple University

Study Description

Brief Summary:

Between twenty and fifty percent of people who have acute stroke have hyperglycemia (high blood sugar) with it. The purpose of this study is to examine the relationships between diabetes mellitus, hyperglycemia,whole blood tissue factor procoagulant activity (TF-PCA) and plasma factorVIIa (FVIIa) in ten patients with type 2 diabetes mellitus and 11 non-diabetic patients at baseline and 6, 12, 24, and 48 hours (h) after presentation for acute stroke.

Condition or disease
Ischemic Stroke; Hyperglycemia

Detailed Description:

The purpose of this study is to examine the relationships between diabetes mellitus, hyperglycemia,whole blood tissue factor procoagulant activity (TF-PCA) and plasma factorVIIa (FVIIa) in ten patients with type 2 diabetes mellitus and 11 non-diabetic patients at baseline and 6, 12, 24, and 48 hours (h) after presentation for acute stroke.

Patients presenting to the Emergency Department with ongoing stroke symptoms and neurologic deficit less than 24 hours (h) duration were screened for inclusion into the study. Stroke patients were grouped in terms of diabetes status as determined by past medical history. Stroke diagnosis was confirmed with brain magnetic resonance imaging (MRI). Clinical care, including the acute management ofstroke and hyperglycemia, was done at the discretion of the Neurology service not involved in the study.

Study Design

• Study Type: Observational
• Actual Enrollment: 21 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study
• Study Start Date: October 2001
• Actual Primary Completion Date: November 2005
• Actual Study Completion Date: November 2005

Groups and Cohorts

Group/Cohort
Diabetic subject; Subjects with acute stroke, hyperglycemia and history of diabetes.
Normoglycemic Control; Subjects with acute stroke and normal blood glucose.

Outcome Measures

Primary Outcome Measures :

1. FVIIa [ Time Frame: Baseline ]
   FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.

Secondary Outcome Measures :

1. TF-PCA [ Time Frame: Baseline ]
   TF-PCA levels compared between normoglycemic and hyperglycemic subjects.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the Emergency Department with acute ischemic stroke within 12 hours of onset of symptoms.

Criteria

Inclusion Criteria:

• Patients aged > 18 years presenting to the Emergency Department with symptoms of acute ischemic stroke will be included for study.
• Acute stroke patients with normal blood glucose levels and patients with fingerstick blood glucose level of greater than or equal to 150 mg/dl will be eligible for study.
• Acute Stroke will be defined as an acute disturbance of cerebral function of presumed vascular origin causing a neurological deficit of less than 24 hours duration.
• Patients must have an NIH Stroke Scale Score of 4 to 23. Patients awakening with symptoms of stroke will be considered to have had their stroke at the time when last awake without symptoms.

Exclusion Criteria:

• Patients presenting after 24 hours of symptom onset. When the actual time of onset is unknown, the time when last observed to be symptom-free will be used.
• Patients with NIH scale of less than 4 or greater than 23.
• Complete or substantial resolution of symptoms before randomization.
• Patients with a previously disabling stroke (modified Rankin score > 3)
• Patients with other systemic disease such as infection (eg pneumonia, etc)
• Patients with hemorrhage visualized on CT.
• Patients who are unwilling or unable to give informed consent, or for whom a legally authorized representative is not able to consent.
• Pregnant patients.

Contacts and Locations

Sponsors and Collaborators

Temple University

Investigators

• Principal Investigator: Nina T Gentile, MD; Temple University

More Information

• Responsible Party: Temple University
• ClinicalTrials.gov Identifier: NCT00373269
• Other Study ID Numbers: 3866 4187
• First Posted: September 8, 2006
• Results First Posted: January 4, 2017
• Last Update Posted: February 27, 2017
• Last Verified: January 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Temple University:

Acute ischemic stroke; Stroke; Hyperglycemia; Procoagulation; Diabetes; Blood coagulation

Additional relevant MeSH terms:

Stroke; Ischemic Stroke; Hyperglycemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases