Status:
COMPLETED
Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty
Lead Sponsor:
LifeBridge Health
Collaborating Sponsors:
Haemonetics Corporation
Conditions:
Primary Total Hip and Knee Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 random...
Eligibility Criteria
Inclusion
- Men or women age ≥ 18 years old
- Total knee or total hip arthroplasty planned in the 60 days following study enrollment
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01809054
Start Date
April 1 2012
End Date
February 1 2013
Last Update
April 21 2014
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
2
Sinai Center for Thrombosis Research
Baltimore, Maryland, United States, 21215