Phase 4
N=49
Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty
Primary Total Hip and Knee Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT01809054 ↗Enrolled (actual)
49
Serious AEs
—
Results posted
Apr 2014
Primary outcome: Primary: Blood Loss — 6; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Arixtra (Drug); Pneumatic compression stockings (Device); Aspirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LifeBridge Health
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Loss |
6; 1 | — |
| SECONDARY Deep Vein Thrombosis |
0; 0 | — |
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.
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
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.