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Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373269
First Posted: September 8, 2006
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Temple University
  Purpose
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
Ischemic Stroke Hyperglycemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • FVIIa [ Time Frame: Baseline ]
    FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.


Secondary Outcome Measures:
  • TF-PCA [ Time Frame: Baseline ]
    TF-PCA levels compared between normoglycemic and hyperglycemic subjects.


Enrollment: 21
Study Start Date: October 2001
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetic subject
Subjects with acute stroke, hyperglycemia and history of diabetes.
Normoglycemic Control
Subjects with acute stroke and normal blood glucose.

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373269


Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Nina T Gentile, MD Temple University
  More Information

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00373269     History of Changes
Other Study ID Numbers: 3866 4187
First Submitted: September 5, 2006
First Posted: September 8, 2006
Results First Submitted: November 4, 2016
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
Hyperglycemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases