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

LifeBridge Health

Status and phase: Completed; Phase 4

Conditions: Primary Total Hip and Knee Arthroplasty

Treatments: Drug: Arixtra; Device: Pneumatic compression stockings; Drug: Aspirin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01809054

1888

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men or women age ≥ 18 years old
2. Total knee or total hip arthroplasty planned in the 60 days following study enrollment

Exclusion criteria

1. Pre-existing anti-coagulant therapy (Heparin, Lovenox, Arixtra, Warfarin, Xarelto, and all other non-mentioned anticoagulants) on admission
2. History of bleeding diathesis
3. Known active malignancy
4. Prothrombin time >1.5 x control
5. Platelet count < 100,000/mm3, hematocrit < 30%, creatinine clearance <30 mL/min
6. Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Bacterial endocarditis
7. Major surgery within past 3 months of enrollment
8. Patients requiring bilateral arthroplasty
9. Body weight <50 kg (venous thromboembolism prophylaxis only)
10. Unable to return to site for follow-up visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Arixtra Arm

Active Comparator group

Description:

Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks

Treatment:

Drug: Aspirin

Drug: Arixtra

Pneumatic compression stockings arm

Active Comparator group

Description:

Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.

Treatment:

Drug: Aspirin

Device: Pneumatic compression stockings