Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty

Conditions
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Primary Total Hip and Knee Arthroplasty

Intervention / Treatment
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* Drug: Arixtra
* Device: Pneumatic compression stockings
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arixtra Arm<br>Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks | Drug: Arixtra<br> <br> Drug: Aspirin<br> <br> |
| Active Comparator: Pneumatic compression stockings arm<br>Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks. | Device: Pneumatic compression stockings<br>* Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)<br>Drug: Aspirin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Loss | requiring transfusion | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deep Vein Thrombosis | verified by ultrasound | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Knee, Arthroplasty, venous thromboembolic events, blood loss