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Glucose Regulation in Acute Stroke Patients (GRASP) Study

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00282867
First received: January 26, 2006
Last updated: July 15, 2009
Last verified: July 2009
Results First Received: July 14, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Stroke
Hyperglycemia
Interventions: Drug: IV glucose insulin and potassium, GIK
Other: standard care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tight Control Group target glucose level 70-110 mg/dL
Loose Control Group target glucose level 70 – 200 mg/dL
Usual Care Group target level 70 - 300 mg/dL

Participant Flow:   Overall Study
    Tight Control Group   Loose Control Group   Usual Care Group
STARTED   24   25   25 
COMPLETED   23   24   25 
NOT COMPLETED   1   1   0 
d/c prior to prim outcome, 3 m f/u done                1                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Tight Control Group target glucose level 70-110 mg/dL
Loose Control Group target glucose level 70 – 200 mg/dL
Usual Care Group target level 70 - 300 mg/dL
Total Total of all reporting groups

Baseline Measures
   Tight Control Group   Loose Control Group   Usual Care Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   25   25   74 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   11   8   12   31 
>=65 years   13   17   13   43 
Gender 
[Units: Participants]
       
Female   11   12   10   33 
Male   13   13   15   41 
Region of Enrollment 
[Units: Participants]
       
United States   24   25   25   74 


  Outcome Measures
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1.  Primary:   Hypoglycemic Events   [ Time Frame: up to 5 days ]

2.  Secondary:   Favorable 3 Month Modified Rankin   [ Time Frame: 3 months ]

3.  Other Pre-specified:   Symptomatic Hypoglycemia   [ Time Frame: up to 5 days ]

4.  Post-Hoc:   Target Glucose Concentration   [ Time Frame: first 24 hours after initiation of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Karen C. Johnston, MD, MSc
Organization: University of Virginia
phone: 434 924-5323
e-mail: kj4v@virginia.edu



Responsible Party: Karen C. Johnston, MD, MSc, PI, Professor and Chair Department of Neurology, University of Virginia
ClinicalTrials.gov Identifier: NCT00282867     History of Changes
Other Study ID Numbers: 11901
R01NS050192 ( US NIH Grant/Contract Award Number )
Study First Received: January 26, 2006
Results First Received: July 14, 2009
Last Updated: July 15, 2009
Health Authority: United States: Federal Government