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Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT00373269
First received: September 5, 2006
Last updated: January 11, 2017
Last verified: January 2017

September 5, 2006
January 11, 2017
October 2001
November 2005   (Final data collection date for primary outcome measure)
FVIIa [ Time Frame: Baseline ]
FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.
  • Change in infarct volume at Week 1 from baseline as measured on diffusion - perfusion magnetic resonance imaging
  • Analyses of group mean infarct volume and the mean percent change from baseline to Week 1
Complete list of historical versions of study NCT00373269 on ClinicalTrials.gov Archive Site
TF-PCA [ Time Frame: Baseline ]
TF-PCA levels compared between normoglycemic and hyperglycemic subjects.
  • Blood sugar: at hour 0.25, 0.5, 1, 2,4,6,8,12,16,20,24, 36, 48
  • Coagulation Studies at hour: 0, 6,12,24,48
  • Neurological Assessment hr 0, 48, week 1 and week 12: NIHSS, Barthel Index, Modified Rankin Score
  • Mortality rates
Not Provided
Not Provided
 
Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study
Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients presenting to the Emergency Department with acute ischemic stroke within 12 hours of onset of symptoms.
  • Ischemic Stroke
  • Hyperglycemia
Not Provided
  • Diabetic subject
    Subjects with acute stroke, hyperglycemia and history of diabetes.
  • Normoglycemic Control
    Subjects with acute stroke and normal blood glucose.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
November 2005
November 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00373269
3866 4187
No
Not Provided
No
Not Provided
Temple University
Temple University
Not Provided
Principal Investigator: Nina T Gentile, MD Temple University
Temple University
January 2017

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