Status:
UNKNOWN
Prophylaxis Against DVTs After Primary Hip and Knee Replacement Surgery
Lead Sponsor:
The New England Baptist Hospital
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
20+ years
Phase:
NA
Brief 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, swe...
Detailed Description
Inclusion Criteria: 1. Planned for elective primary arthroplasty for knee and hip disease at New England Baptist Hospital. 2. Over 20 years of age. 3. Normal baseline platelet count, prothrombin and ...
Eligibility Criteria
Inclusion
- 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
- 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
- Uncontrolled hypertension
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00767559
Start Date
November 1 2008
End Date
October 1 2012
Last Update
September 26 2011
Active Locations (1)
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1
New England Baptist Hospital
Boston, Massachusetts, United States, 02120