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OpenTrials
Completed

NCT Number: NCT00373269

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. FVIIa

    Time frame: Baseline

    FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.

Secondary outcomes

  1. TF-PCA

    Time frame: Baseline

    TF-PCA levels compared between normoglycemic and hyperglycemic subjects.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Sep 8, 2006
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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