Clinical trial NCT00373269: Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study
Official title: Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Hyperglycemia
Keywords: Acute ischemic stroke
Stroke
Hyperglycemia
Procoagulation
Diabetes
Blood coagulation
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the Emergency Department with acute ischemic stroke within 12 hours of onset of symptoms.

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.

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 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.

Primary outcomes:
measure: FVIIa
timeFrame: Baseline
Secondary outcomes:
measure: TF-PCA
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Temple University
name: Nina T Gentile, MD
role: PRINCIPAL_INVESTIGATOR
References: