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

Phase 4

Completed

• Conditions: Primary Total Hip and Knee Arthroplasty
• Interventions: Drug: Arixtra; Device: Pneumatic compression stockings; Drug: Aspirin

• Registration Number: NCT01809054
• Lead Sponsor: LifeBridge Health

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:

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-08
• Study First Posted: 2013-03-12
• Status Verified: 2014-03
• Results First Submitted: 2014-03-18
• Results First Submitted QC: 2014-03-18
• Last Update Submitted: 2014-03-18
• Results First Posted: 2014-04-21
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arixtra Arm	Arixtra	Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Pneumatic compression stockings arm	Aspirin	Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Pneumatic compression stockings arm	Pneumatic compression stockings	Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Arixtra Arm	Aspirin	Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks

Primary Outcome Measures

Name	Time	Method
Blood Loss	6 weeks	requiring transfusion

Secondary Outcome Measures

Name	Time	Method
Deep Vein Thrombosis	6 weeks	verified by ultrasound

Trial Locations

Locations (2)

Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

Sinai Center for Thrombosis Research; 🇺🇸 Baltimore, Maryland, United States