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The Use of Fondaparinux in Preventing Thromboembolism in High Risk Trauma Patients

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Mary Knudson, M.D., University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00531843
First received: September 17, 2007
Last updated: October 31, 2013
Last verified: October 2013
History of Changes
Results First Received: June 10, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Venous Thromboembolism
Interventions: Drug: fondaparinux sodium
Device: sequential compression devices

  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
During a 6-month period, consecutive adults presenting to one Level I urban trauma center were screened for eligibility, enrolled and assigned to a treatment category using previously-developed clinical guidelines.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 105 enrolled participants, 18 were excluded from analysis (13 discharged or transferred prior to second venous ultrasonography; 4 received non-study DVT prophylaxis; 1 had a known protein-C deficiency).

Reporting Groups
  Description
Fondaparinux Sodium Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg via subcutaneous administration (SubQ) daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
No Fondaparinux Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary inferior vena cava (IVC) filter (prn as determined by caregiver).

Participant Flow:   Overall Study
    Fondaparinux Sodium     No Fondaparinux  
STARTED     81     6  
COMPLETED     81     6  
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
Fondaparinux Sodium Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
No Fondaparinux Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
Total Total of all reporting groups

Baseline Measures
    Fondaparinux Sodium     No Fondaparinux     Total  
Number of Participants  
[units: participants]
 		  81     6     87  
Age  
[units: years]
Mean ± Standard Deviation 		  43.1  ± 19.3     56.8  ± 20.9     44.3  ± 19.7  
Gender  
[units: participants]
 		     
Female     21     1     22  
Male     60     5     65  
Region of Enrollment  
[units: participants]
 		     
United States     81     6     87  



  Outcome Measures
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1.  Primary:   Presence of Deep Vein Thrombosis (DVT) or Pulmonary Embolus (PE)   [ Time Frame: within 3 weeks post injury ]
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2.  Secondary:   Normal Trough and Peak Fondaparinux Concentration   [ Time Frame: Day 3 ]
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3.  Secondary:   Increased Bleeding Attributed to Fondaparinux   [ Time Frame: 3 weeks post injury ]
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  Serious Adverse Events
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  Other Adverse Events
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  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: M. Margaret Knudson, MD
Organization: UCSF/SF General Hospital
phone: 415.205.4623
e-mail: pknudson@sfghsurg.ucsf.edu


Publications of Results:

Other Publications:


Responsible Party: Mary Knudson, M.D., University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00531843     History of Changes
Other Study ID Numbers: H6693-30799-01
Study First Received: September 17, 2007
Results First Received: June 10, 2013
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration