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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
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Mary Knudson, M.D., University of California, San Francisco

Study Type Interventional
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
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
Hide Arm/Group Description 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
Arm/Group Title Fondaparinux Sodium No Fondaparinux Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 81 participants 6 participants 87 participants
Female
21
  25.9%
1
  16.7%
22
  25.3%
Male
60
  74.1%
5
  83.3%
65
  74.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 81 participants 6 participants 87 participants
81 6 87
1.Primary Outcome
Title Presence of Deep Vein Thrombosis (DVT) or Pulmonary Embolus (PE)
Hide Description Color-flow duplex venous ultrasonography examinations of upper and lower extremities were performed within 48 hours of injury, and then weekly until discharge or 3 weeks. DVT was defined as any clot occurring in the subclavian, iliac, femoral, or popliteal location. Patients were examined daily for clinical signs and symptoms of venous thromboembolism (VTE) and PE. Small, nonocclusive clots discovered in other locations were observed for progression on sequential ultrasonography examinations.
Time Frame within 3 weeks post injury
Hide Outcome Measure Data
Hide Analysis Population Description
Of 11 patients with initial contraindication to anticoagulation, 5 were cleared by the treating physicians to receive fondaparinux within 3 days of injury, and 6 were not.
Arm/Group Title Fondaparinux Sodium No Fondaparinux
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 81 6
Measure Type: Number
Unit of Measure: participants
DVT 2 2
DVT after fondaparinux 1 NA [1] 
PE 0 0
[1]
This arm/group did not receive Fondaparinux.
2.Secondary Outcome
Title Normal Trough and Peak Fondaparinux Concentration
Hide Description Serum samples were collected 30 minutes before (trough) and 2 hours after (peak) the third dose of fondaparinux. Normative data plots comparing study participants with healthy volunteers were supplied by the company outsourced to analyze samples.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Serum samples were obtained from 63 representative patients from our study who received Fondaparinux and compared against normative values from normal volunteers supplied by our sponsor.
Arm/Group Title Fondaparinux Sodium No Fondaparinux
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 63 0
Measure Type: Number
Unit of Measure: Participants
Trough values outside normative range 0
Peak values outside normative range 0
3.Secondary Outcome
Title Increased Bleeding Attributed to Fondaparinux
Hide Description Coagulopathic bleeding due to fondaparinux was suspected in patients requiring packed red cell transfusions after initiation of fondaparinux therapy only if the change in hematocrit prompting transfusion was not clinically commensurate with the degree of injuries that the patient had sustained (primarily orthopaedic) and/or the hematocrit did not respond appropriately post-transfusion.
Time Frame 3 weeks post injury
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fondaparinux Sodium No Fondaparinux
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 81 0
Measure Type: Number
Unit of Measure: participants
0
Time Frame 3 weeks post-injury
Adverse Event Reporting Description This study did not record adverse events that were related to the severity of participants' trauma unless assessed for potential attribution to study participation
 
Arm/Group Title Fondaparinux Sodium No Fondaparinux
Hide Arm/Group Description 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).
All-Cause Mortality
Fondaparinux Sodium No Fondaparinux
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Fondaparinux Sodium No Fondaparinux
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/81 (0.00%)      0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Fondaparinux Sodium No Fondaparinux
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/81 (16.05%)      2/6 (33.33%)    
Blood and lymphatic system disorders     
Drop in hematocrit   13/81 (16.05%)  13 0/6 (0.00%)  0
Vascular disorders     
DVT   2/81 (2.47%)  2 2/6 (33.33%)  2
Superficial nonoccluding clots   4/81 (4.94%)  4 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: M. Margaret Knudson, MD
Organization: UCSF/SF General Hospital
Phone: 415.205.4623
EMail: pknudson@sfghsurg.ucsf.edu
Other Publications:
Layout table for additonal information
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