Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty
Overview
- Phase
- Phase 4
- Intervention
- Aspirin
- Conditions
- Primary Total Hip and Knee Arthroplasty
- Sponsor
- LifeBridge Health
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Blood Loss
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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:
- Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks, or
- Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men or women age ≥ 18 years old
- •Total knee or total hip arthroplasty planned in the 60 days following study enrollment
Exclusion Criteria
- •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
Arms & Interventions
Arixtra Arm
Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Intervention: Aspirin
Arixtra Arm
Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Intervention: Arixtra
Pneumatic compression stockings arm
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Intervention: Pneumatic compression stockings
Pneumatic compression stockings arm
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Intervention: Aspirin
Outcomes
Primary Outcomes
Blood Loss
Time Frame: 6 weeks
requiring transfusion
Secondary Outcomes
- Deep Vein Thrombosis(6 weeks)