Phase 4 Completed N=49 Randomized Treatment

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

Primary Total Hip and Knee Arthroplasty

Source: ClinicalTrials.gov NCT01809054 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Apr 2014

Primary outcomePrimary: Blood Loss — 6; 1 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Blood Loss	6; 1	—
SECONDARY Deep Vein Thrombosis	0; 0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01809054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.