N/A
N=21
Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study
Ischemic Stroke · Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT00373269 ↗Enrolled (actual)
21
Serious AEs
—
Results posted
Jan 2017
Primary outcome: Primary: FVIIa — 69.7; 124.4 mU/ml
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Temple University
- Primary completion
- Nov 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FVIIa |
69.7; 124.4 | — |
| SECONDARY TF-PCA |
183.5; 118.1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00373269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.