The Use of Fondaparinux in Preventing Thromboembolism in High Risk Trauma Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00531843 |
Recruitment Status :
Completed
First Posted : September 19, 2007
Results First Posted : December 24, 2013
Last Update Posted : December 24, 2013
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Venous Thromboembolism | Drug: fondaparinux sodium Device: sequential compression devices | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 105 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | The Use of Fondaparinux in Preventing Thromboembolism in High Risk Trauma Patients |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1A
Patients at high risk for venous thromboembolism (criteria: age>=40, pelvic fracture, lower extremity fracture, shock on presentation, spinal cord injury, head injury with Abbreviated Injury Scale (AIS) >=3). These patients will receive fondaparinux 2.5mg via subcutaneous administration (SubQ) daily.
|
Drug: fondaparinux sodium
fondaparinux 2.5mg SubQ daily for DVT prophylaxis to be started by treating physicians once deemed safe and to be discontinued once patient in discharged from the hospital or at discretion of treating physicians.
Other Name: Arixtra |
Active Comparator: 1B
Patients at high risk for venous thromboembolism (criteria: age>=40, pelvic fracture, lower extremity fracture, shock on presentation, spinal cord injury, head injury with AIS >=3) who also have a contraindication to anticoagulant(enoxaparin)administration such as renal failure with creatine clearance <30 mL/min, head injury with head AIS >=3), uncontrolled hemorrhage, uncorrected coagulopathy, persistent thrombocytopenia. These patients will receive mechanical compression.
|
Device: sequential compression devices
Sequential compression devices at all times during the patient's hospital admission will be used in patients who have a contraindication to pharmacologic DVT prophylaxis. This is already the current standard of care.
Other Name: Arixtra |
Experimental: 2A
Patients at very high risk for venous thromboembolism (criteria: major operative procedure, venous injury, ventilator days >3, 2 or more high risk factors). These patients will receive fondaparinux 2.5mg SubQ daily and mechanical compression.
|
Drug: fondaparinux sodium
fondaparinux 2.5mg SubQ daily for DVT prophylaxis to be started by treating physicians once deemed safe and to be discontinued once patient in discharged from the hospital or at discretion of treating physicians.
Other Name: Arixtra |
Active Comparator: 2B
Patients at very high risk for venous thromboembolism (criteria: major operative procedure, venous injury, ventilator days >3, 2 or more high risk factors) who also have a contraindication to anticoagulant(enoxaparin)administration such as renal failure creatine clearance <30 mL/min, head injury with head AIS >=3), uncontrolled hemorrhage, uncorrected coagulopathy, persistent thrombocytopenia. These patients will receive mechanical compression and possibly temporary inferior vena cava (IVC) filter(as determined by the patient's care givers).
|
Device: sequential compression devices
Sequential compression devices at all times during the patient's hospital admission will be used in patients who have a contraindication to pharmacologic DVT prophylaxis. This is already the current standard of care.
Other Name: Arixtra |
- Presence of Deep Vein Thrombosis (DVT) or Pulmonary Embolus (PE) [ Time Frame: within 3 weeks post injury ]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.
- Normal Trough and Peak Fondaparinux Concentration [ Time Frame: Day 3 ]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.
- Increased Bleeding Attributed to Fondaparinux [ Time Frame: 3 weeks post injury ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients age ≥ 18 years old admitted to San Francisco General Hospital for injury with at least one risk factor for venous thromboembolism (VTE).
Risk factors are: Age ≥ 40 years, pelvic fracture, lower extremity fracture, spinal cord injury, shock or head injury, major operative procedure, mechanical ventilation > 3 days, venous injury
Exclusion Criteria:
- prisoners
- pregnant patients
- patients who are anticipated to have a < 5 day length of stay as determined by the admitting trauma surgeon
- patients who decline to participate in the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531843
United States, California | |
San Francisco General Hospital | |
San Francisco, California, United States, 94143 |
Principal Investigator: | M. Margaret Knudson, MD | The University of California, San Francisco |
Other Publications:
Responsible Party: | Mary Knudson, M.D., Principal Investigator, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00531843 |
Other Study ID Numbers: |
H6693-30799-01 |
First Posted: | September 19, 2007 Key Record Dates |
Results First Posted: | December 24, 2013 |
Last Update Posted: | December 24, 2013 |
Last Verified: | October 2013 |
deep vein thrombosis venous thromboembolism pulmonary embolism |
Thromboembolism Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases PENTA Fondaparinux Factor Xa Inhibitors |
Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents |