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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-02-28

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:

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.

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Detailed Description

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Conditions

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Primary Total Hip and Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arixtra Arm

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

Group Type ACTIVE_COMPARATOR

Arixtra

Intervention Type DRUG

Aspirin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Pneumatic compression stockings

Intervention Type DEVICE

Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)

Aspirin

Intervention Type DRUG

Interventions

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Arixtra

Intervention Type DRUG

Pneumatic compression stockings

Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)

Intervention Type DEVICE

Aspirin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No