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Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT00373269
First received: September 5, 2006
Last updated: January 11, 2017
Last verified: January 2017
Results First Received: November 4, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Ischemic Stroke
Hyperglycemia

  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
Normoglycemic Control Subjects with acute ischemic stroke and normal blood glucose.
Hyperglycemic Subjects Subjects with acute ischemic stroke and hyperglycemia.

Participant Flow:   Overall Study
    Normoglycemic Control   Hyperglycemic Subjects
STARTED   11   10 
COMPLETED   11   10 
NOT COMPLETED   0   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
Normoglycemic Subjects with acute ischemic stroke and normal blood glucose.
Hyperglycemic Subjects with acute ischemic stroke and hyperglycemia.
Total Total of all reporting groups

Baseline Measures
   Normoglycemic   Hyperglycemic   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   10   21 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6  54.5%      7  70.0%      13  61.9% 
>=65 years      5  45.5%      3  30.0%      8  38.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.9  (17.7)   63.5  (9.2)   64.2  (18.4) 
Gender 
[Units: Participants]
Count of Participants
     
Female      5  45.5%      7  70.0%      12  57.1% 
Male      6  54.5%      3  30.0%      9  42.9% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   11   10   21 


  Outcome Measures
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1.  Primary:   FVIIa   [ Time Frame: Baseline ]

2.  Secondary:   TF-PCA   [ Time Frame: Baseline ]


  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: Dr. Nina T. Gentile
Organization: Temple University
phone: 215-707-8402
e-mail: ngentile@temple.edu



Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00373269     History of Changes
Other Study ID Numbers: 3866 4187
Study First Received: September 5, 2006
Results First Received: November 4, 2016
Last Updated: January 11, 2017