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Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients
This study has been terminated.
( See Detailed Description )
Study NCT00445328   Information provided by Pfizer
First Received: March 7, 2007   Last Updated: October 5, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Open Label, Parallel Assignment
Condition: Venous Thromboembolism
Interventions: Drug: Dalteparin (Fragmin)
Drug: Unfractionated heparin

  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
Dalteparin 5000 IU (International Units) dalteparin in 0.2 mL (milliliters) subcutaneously once a day (Arm A)
Unfractionated Heparin 5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.

Participant Flow:   Overall Study
  Dalteparin Unfractionated Heparin
STARTED   42     42  
      Received Treatment               41[1]               42  
COMPLETED   39     36  
NOT COMPLETED   3     6  
      Death               0                 1  
      Adverse Event               0                 3  
      unknown               0                 2  
      Withdrawal by Subject               2                 0  
      Protocol Violation               1                 0  
[1] 1 subject discontinued after enrollment but prior to study treatment.



  Baseline Characteristics
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Reporting Groups
  Description
Dalteparin 5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
Unfractionated Heparin 5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.

Baseline Measures
  Dalteparin Unfractionated Heparin Total
Number of Participants  
[units: participants]
41 42 83
Age  
[units: years]
Mean ± Standard Deviation
61.7 ± 10.6 60.8 ± 10.9 61.3 ± 10.7
Gender  
[units: participants]
     
Female 18 21 39
Male 23 21 44



  Outcome Measures
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1.  Primary:   Confirmed Thromboembolic Events   [ Day 21 ]

2.  Primary:   Composite of Objectively Verified Thromboembolic Events   [ Day 21 ]

3.  Secondary:   All Cause Mortality   [ Day 14, Day 21 (End of Study) ]

4.  Secondary:   Stroke - Ischemic or Hemorrhagic   [ Day 21 ]

5.  Secondary:   Bleeding - Major or Minor   [ Day 21 ]

6.  Secondary:   Allergic Reactions (Drug-related)   [ Day 21 ]

7.  Secondary:   Thrombocytopenia   [ Day 21 ]


  Serious Adverse Events
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  Other Adverse Events
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