Prophylaxis Against DVTs After Primary Hip and Knee Replacement Surgery (DVT)
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|ClinicalTrials.gov Identifier: NCT00767559|
Recruitment Status : Unknown
Verified September 2011 by The New England Baptist Hospital.
Recruitment status was: Active, not recruiting
First Posted : October 7, 2008
Last Update Posted : September 26, 2011
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 or disease||Intervention/treatment||Phase|
|Pulmonary Embolism||Drug: warfarin Drug: Fondaparinux:||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Prophylaxis Against Thromboembolic Disease Following Orthopaedic Surgeries on Extremities|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||October 2012|
Active Comparator: 1
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 2.0-2.5)
5 mg beginning the night before surgery, followed by 5 mg the PM of surgery*, and then variable daily dose, until day 28 (+/-2 days) from day of surgery follow-up. (target INR 2.0 -2.5)
Other Name: Coumadin
Active Comparator: 2
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 follow-up (28 days +/-2) from day of surgery.
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 follow up day 28 (+/-2 days) from day of surgery.
Other Name: Arixtra
Active Comparator: 3
Fixed Low Dose warfarin
1 mg daily beginning 7 days preoperative, and continued at 1 mg daily follow-up at Day 28 (+/-2 days from surgery).
Fixed Low Dose warfarin
1 mg daily beginning 7 days preoperative, and continued at 1 mg daily until follow-up 28 day (+/- 2 days) from day of surgery.
Other Name: coumadin
- Primary Outcome based upon intent to treat: Composite outcome of [ Time Frame: 28 days ]
- Ultrasound or venogram confirmed deep vein thrombosis. [ Time Frame: 28 days ]
- Lung scan, pulmonary angiogram or CTA confirmed pulmonary embolus. [ Time Frame: 28 days ]
- Death due to TED [ Time Frame: 28 days ]
- Patient compliance with preoperative and post-operative medication schedule. Not enough space to note all measures [ Time Frame: 28 days ]
- Distribution of proximal vs distal deep vein thrombosis of the leg [ Time Frame: 28 days ]
- Amount of intraoperative bleeding [ Time Frame: follow until Dec. 31, 2010 ]
- Amount of postoperative bleeding A. transfusion requirement B. Hematomas requiring intervention, or other bleed clinically thought to be related to study drug. C. Other hemorrhagic events. [ Time Frame: follow until Dec. 31, 2010 ]
- Number of ultrasounds and V/Q or CTA's required [ Time Frame: follow until Dec. 31, 2010 ]
- Costs associated with each study arm, including that of drug, laboratory monitors, radiology procedures required, lengths of stay, and management of complications [ Time Frame: follow until Dec. 31, 2010 ]
- Determine if negative D-D dimer can eliminate need for ultrasound analysis at follow-up visit. [ Time Frame: follow until Dec. 31, 2010 ]
- Death due to any other cause than TED [ Time Frame: follow until Dec. 31, 2010 ]
- Use of low molecular weight dextran [ Time Frame: follow until Dec. 31, 2010 ]
- Use of nonsteroidal anti-inflammatory drugs [ Time Frame: follow until Dec. 31, 2010 ]
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): NCT00767559
|United States, Massachusetts|
|New England Baptist Hospital|
|Boston, Massachusetts, United States, 02120|
|Principal Investigator:||Murray Bern, MD||New England Baptist Hospital|