Glucose Regulation in Acute Stroke Patients (GRASP) Study
2 other identifiers
interventional
74
1 country
2
Brief Summary
The purpose of this study is to assess the feasibility, safety and preliminary efficacy of the use of insulin infusions as treatment for hyperglycemic acute ischemic stroke patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 stroke
Started May 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2006
CompletedFirst Posted
Study publicly available on registry
January 27, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
August 21, 2009
CompletedAugust 21, 2009
July 1, 2009
1.8 years
January 26, 2006
July 14, 2009
July 15, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hypoglycemic Events
hypoglycemic events
up to 5 days
Secondary Outcomes (1)
Favorable 3 Month Modified Rankin
3 months
Other Outcomes (1)
Symptomatic Hypoglycemia
up to 5 days
Study Arms (3)
tight control group
ACTIVE COMPARATORtarget glucose level 70-110 mg/dL
loose control group
ACTIVE COMPARATORtarget glucose level 70 - 200 mg/dL
usual care group
ACTIVE COMPARATORtarget level 70 - 300 mg/dL
Interventions
The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.
Eligibility Criteria
You may qualify if:
- years of age or older.
- Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more major vessels.
- Must arrive at hospital and be able to begin treatment within 2 hours of established eligibility and this must be within 24 hours of symptom onset. - - Patients unable to report symptom onset time or those awakening with symptoms must use the time last known to be well as the onset time.
- Admission plasma glucose of \> 110 mg/dL.
You may not qualify if:
- Renal dysfunction as defined by a serum creatinine of \>/=2.5 mg/dL at enrollment.
- Substantial pre-existing neurological or psychiatric illness that would confound neurological assessment.
- Patients who have received experimental therapy for the enrollment stroke.
- Pregnant females.
- Patients with other severe life threatening conditions that makes them unlikely to survive 90 days.
- Patients who are unable to follow the protocol or come back for 90-day followup.
- Patient has condition for which insulin infusion is the usual practice or the treating physician feels that there is an indication for insulin infusion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Medical College of Georgia
Augusta, Georgia, 30912, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Karen C. Johnston, MD, MSc
- Organization
- University of Virginia
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Johnston, MD
University of Virginia, Department of Neurology
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 26, 2006
First Posted
January 27, 2006
Study Start
May 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2009
Last Updated
August 21, 2009
Results First Posted
August 21, 2009
Record last verified: 2009-07