Prophylaxis Against DVTs After Primary Hip and Knee Replacement Surgery

• Status: Unknown status
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The New England Baptist Hospital
• Treatments: Fondaparinux; PENTA; Warfarin

Criteria

Inclusion Criteria:

1. Planned for elective arthroplasty for knee and hip disease.

2. Over 20 years of age.

3. Normal baseline platelet count, prothrombin and partial thromboplastin times.

4. Signed consent.

Exclusion Criteria:

1. Surgery for acute fracture (< 4 weeks), septic joint, or extraction arthroplasty.

2. Patients with personal history of TED, or documented hypercoagulation disease.

3. Increased risk of hemorrhage, as from active gastric ulcer, or bleeding diathesis; or persistent intestinal or urinary tract bleed within the last year.

4. Hemorrhagic stroke; brain, spinal, or ophthalmologic surgery in previous 6 months.

5. Liver enzymes or bilirubin greater than 2 x normal.

6. Decreased renal function with GFR < 30ml/min. (24-27)

7. Cancer in last 1 year, other than localized cancers of the skin.

8. Requires chronic anticoagulation with warfarin or heparins.

9. Requires chronic platelet function suppressive therapy for coronary or peripheral artery stents..

10. Prior adverse reaction to any of the study drugs.

11. Pregnancy

12. Uncontrolled hypertension