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; Intervention Model: Parallel Assignment; Masking: None (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
Overall Participants Analyzed [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:

Lu JP, Knudson MM, Bir N, Kallet R, Atkinson K. Fondaparinux for prevention of venous thromboembolism in high-risk trauma patients: a pilot study. J Am Coll Surg. 2009 Nov;209(5):589-94. doi: 10.1016/j.jamcollsurg.2009.08.001. Epub 2009 Sep 11.

Other Publications:

Agnelli G, Bergqvist D, Cohen AT, Gallus AS, Gent M; PEGASUS investigators. Randomized clinical trial of postoperative fondaparinux versus perioperative dalteparin for prevention of venous thromboembolism in high-risk abdominal surgery. Br J Surg. 2005 Oct;92(10):1212-20.

Geerts WH, Jay RM, Code KI, Chen E, Szalai JP, Saibil EA, Hamilton PA. A comparison of low-dose heparin with low-molecular-weight heparin as prophylaxis against venous thromboembolism after major trauma. N Engl J Med. 1996 Sep 5;335(10):701-7.

Velmahos GC. Posttraumatic thromboprophylaxis revisited: an argument against the current methods of DVT and PE prophylaxis after injury. World J Surg. 2006 Apr;30(4):483-7.

Hill AB, Garber B, Dervin G, Howard A. Heparin prophylaxis for deep venous thrombosis in a patient with multiple injuries: an evidence-based approach to a clinical problem. Can J Surg. 2002 Aug;45(4):282-7.

Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, Ray JG. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):338S-400S. Review.

Turpie AG, Bauer KA, Eriksson BI, Lassen MR; PENTATHALON 2000 Study Steering Committee. Postoperative fondaparinux versus postoperative enoxaparin for prevention of venous thromboembolism after elective hip-replacement surgery: a randomised double-blind trial. Lancet. 2002 May 18;359(9319):1721-6. Erratum in: Lancet 2002 Oct 5;360(9339):1102.

Kudsk KA, Fabian TC, Baum S, Gold RE, Mangiante E, Voeller G. Silent deep vein thrombosis in immobilized multiple trauma patients. Am J Surg. 1989 Dec;158(6):515-9.

Knudson MM, Ikossi DG. Venous thromboembolism after trauma. Curr Opin Crit Care. 2004 Dec;10(6):539-48. Review.

Donat F, Duret JP, Santoni A, Cariou R, Necciari J, Magnani H, de Greef R. The pharmacokinetics of fondaparinux sodium in healthy volunteers. Clin Pharmacokinet. 2002;41 Suppl 2:1-9.

Knudson MM, Ikossi DG, Khaw L, Morabito D, Speetzen LS. Thromboembolism after trauma: an analysis of 1602 episodes from the American College of Surgeons National Trauma Data Bank. Ann Surg. 2004 Sep;240(3):490-6; discussion 496-8.

Eriksson BI, Bauer KA, Lassen MR, Turpie AG; Steering Committee of the Pentasaccharide in Hip-Fracture Surgery Study. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after hip-fracture surgery. N Engl J Med. 2001 Nov 1;345(18):1298-304.

Bauer KA, Eriksson BI, Lassen MR, Turpie AG; Steering Committee of the Pentasaccharide in Major Knee Surgery Study. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after elective major knee surgery. N Engl J Med. 2001 Nov 1;345(18):1305-10.

Geerts WH, Code KI, Jay RM, Chen E, Szalai JP. A prospective study of venous thromboembolism after major trauma. N Engl J Med. 1994 Dec 15;331(24):1601-6.

Allen TL, Carter JL, Morris BJ, Harker CP, Stevens MH. Retrievable vena cava filters in trauma patients for high-risk prophylaxis and prevention of pulmonary embolism. Am J Surg. 2005 Jun;189(6):656-61.

Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. Epub 2006 Jan 26.

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

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