Prophylaxis Against DVTs After Hip and Knee Surgery - Full Text View

Sponsored by:	The New England Baptist Hospital
Information provided by:	The New England Baptist Hospital
ClinicalTrials.gov Identifier:	NCT00767559

Purpose

The purpose of this research is to find a better way to prevent the post operative development of clots in the deep veins of the legs (also called Deep Vein Thrombosis or DVT). DVT causes redness, swelling, and pain in the involved leg(s). Long-term complications may include permanent swelling and pain of the leg(s), and even skin ulcers around the ankle. If clots form in a leg after surgery, and break off, they can move to the lungs and block the pulmonary artery (also called Pulmonary Emboli or PE). With PE there can be chest pain, chest tightness, shortness of breath, coughing up blood, heart failure, and occasionally death.

Doctors have studied ways to reduce these complications. These studies led to the development of drugs which interfere with your body's clotting processes. However, it is still unclear which drug and which drug schedule is best. This study will evaluate two of the standard FDA approved drugs using different dosing schedules.

Condition	Intervention
Thromboembolic Disease	Drug: warfarin Drug: Fondaparinux:

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis

Drug Information available for: Fondaparinux sodium ORG 31540 Warfarin Warfarin potassium Warfarin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prophylaxis Against Thromboembolic Disease Following Orthopaedic Surgeries on Extremities

Further study details as provided by The New England Baptist Hospital:

Primary Outcome Measures:

Primary Outcome based upon intent to treat: Composite outcome of [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Ultrasound or venogram confirmed deep vein thrombosis. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Lung scan, pulmonary angiogram or CTA confirmed pulmonary embolus. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Death due to TED [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Patient compliance with preoperative and post-operative medication schedule. Not enough space to note all measures [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Distribution of proximal vs distal deep vein thrombosis of the leg [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	660
Study Start Date:	November 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Variable dose warfarin: 5 mg beginning the night before surgery, followed by 5mg the PM of surgery*, and then variable daily dose,until day 30 follow-up. (target INR 1.8-2.0)	Drug: warfarin 5 mg beginning the night before surgery, followed by 5 mg the PM of surgery*, and then variable daily dose, until day 30 follow-up. (target INR 1.8-2.0)
2: Active Comparator Fondaparinux: 2.5 mg daily starting more than 6 hours following surgery and no later than 6 AM the next day*,or 6-8 hours after epidural catheter removal, and continued until day 30 follow-up.	Drug: Fondaparinux: 2.5 mg daily starting more than 6 hours following surgery and no later than 6 AM the next day*, or 6-8 hours after epidural catheter removal, and continued until 30-day follow-up
3: Active Comparator Fixed Low Dose warfarin 1 mg daily beginning 7 days preoperative, and continued at 1 mg daily until day 30 follow-up.	Drug: warfarin Fixed Low Dose warfarin 1 mg daily beginning 7 days preoperative, and continued at 1 mg daily until day 30 follow-up.

Show Detailed Description

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Planned for elective arthroplasty for knee and hip disease.
Over 20 years of age.
Normal baseline platelet count, prothrombin and partial thromboplastin times.
Signed consent.

Exclusion Criteria:

Surgery for acute fracture (< 4 weeks), septic joint, or extraction arthroplasty.
Patients with personal history of TED, or documented hypercoagulation disease.
Increased risk of hemorrhage, as from active gastric ulcer, or bleeding diathesis; or persistent intestinal or urinary tract bleed within the last year.
Hemorrhagic stroke; brain, spinal, or ophthalmologic surgery in previous 6 months.
Liver enzymes or bilirubin greater than 2 x normal.
Decreased renal function with GFR < 30ml/min. (24-27)
Cancer in last 1 year, other than localized cancers of the skin.
Requires chronic anticoagulation with warfarin or heparins.
Requires chronic platelet function suppressive therapy for coronary or peripheral artery stents..
Prior adverse reaction to any of the study drugs.
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767559

Contacts

Contact: Fae L Williams, B.S.	617-754-6664	flwillia@caregroup.harvard.edu
Contact: Charlotte Phillips, B.S.	617-754-5616	cbphilli@caregroup.harvard.edu

Locations

United States, Massachusetts
New England Baptist Hospital
Boston, Massachusetts, United States, 02120

Sponsors and Collaborators

The New England Baptist Hospital

Investigators

Principal Investigator:

Murray Bern, MD

New England Baptist Hospital

More Information

Responsible Party:	New England Baptist Hostpital ( Murray Bern, MD )
Study ID Numbers:	NEBH 2008-016
Study First Received:	October 3, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00767559
Health Authority:	United States: Food and Drug Administration

Keywords provided by The New England Baptist Hospital:

Deep Vein Thrombosis

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases
Fondaparinux
Venous Thrombosis

Warfarin
Org 31540
Thromboembolism
Thrombosis

Additional relevant MeSH terms:

Anticoagulants
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009