Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty
Completed · Phase 4
Conditions studied: Primary Total Hip and Knee Arthroplasty
In brief
This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to detect changes in coagulability following elective total knee and hip arthroplasty. Patients will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital: 1. Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks, or 2. Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Key facts
- Study ID
- NCT01809054
- Run by
- LifeBridge Health
- People needed
- 54
- Starts
- 2012-04-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2014-04-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men or women age ≥ 18 years old
- Total knee or total hip arthroplasty planned in the 60 days following study enrollment
You may not qualify if…
- Pre-existing anti-coagulant therapy (Heparin, Lovenox, Arixtra, Warfarin, Xarelto, and all other non-mentioned anticoagulants) on admission
- History of bleeding diathesis
- Known active malignancy
- Prothrombin time >1.5 x control
- Platelet count < 100,000/mm3, hematocrit < 30%, creatinine clearance <30 mL/min
- Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Bacterial endocarditis
- Major surgery within past 3 months of enrollment
- Patients requiring bilateral arthroplasty
- Body weight <50 kg (venous thromboembolism prophylaxis only)
- Unable to return to site for follow-up visit
Where it is running
- Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore — Baltimore, Maryland, United States
- Sinai Center for Thrombosis Research — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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