The Use of Fondaparinux in Preventing Thromboembolism in High Risk Trauma Patients
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ClinicalTrials.gov Identifier: NCT00531843 |
Recruitment Status :
Completed
First Posted : September 19, 2007
Results First Posted : December 24, 2013
Last Update Posted : December 24, 2013
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Sponsor:
Mary Knudson, M.D.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Mary Knudson, M.D., University of California, San Francisco
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Condition |
Venous Thromboembolism |
Interventions |
Drug: fondaparinux sodium Device: sequential compression devices |
Enrollment | 105 |
Participant Flow
Recruitment Details | 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 | 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). |
Arm/Group Title | Fondaparinux Sodium | No Fondaparinux |
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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. | 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). |
Period Title: Overall Study | ||
Started | 81 | 6 |
Completed | 81 | 6 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Fondaparinux Sodium | No Fondaparinux | Total | |
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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. | 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 of all reporting groups | |
Overall Number of Baseline Participants | 81 | 6 | 87 | |
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[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 81 participants | 6 participants | 87 participants | |
43.1 (19.3) | 56.8 (20.9) | 44.3 (19.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 81 participants | 6 participants | 87 participants | |
Female |
21 25.9%
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1 16.7%
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22 25.3%
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Male |
60 74.1%
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5 83.3%
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65 74.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 81 participants | 6 participants | 87 participants |
81 | 6 | 87 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | M. Margaret Knudson, MD |
Organization: | UCSF/SF General Hospital |
Phone: | 415.205.4623 |
EMail: | pknudson@sfghsurg.ucsf.edu |
Other Publications:
Responsible Party: | Mary Knudson, M.D., University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00531843 |
Other Study ID Numbers: |
H6693-30799-01 |
First Submitted: | September 17, 2007 |
First Posted: | September 19, 2007 |
Results First Submitted: | June 10, 2013 |
Results First Posted: | December 24, 2013 |
Last Update Posted: | December 24, 2013 |