Status:
UNKNOWN
Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery
Lead Sponsor:
Phramongkutklao College of Medicine and Hospital
Collaborating Sponsors:
Chulalongkorn University
Chiang Mai University
Conditions:
Open Fracture of Hip
Eligibility:
All Genders
50+ years
Brief Summary
Arterial and venous thromboembolism represents one of the most common preventable health problems. Patients undergoing surgery, especially hip fracture surgery are at high risk for deep vein thromboem...
Detailed Description
Rivaroxaban is the first agent of a new class of drugs acting as direct factor Xa inhibitors with oral bioavailability. Highly selective inhibition of factor Xa by rivaroxaban is expected to inhibit t...
Eligibility Criteria
Inclusion
- At least 50 years old in men or post-menopause in women
- Patients, who are undergoing standard surgery for fracture of the upper third of the femur, including femoral head, neck, trochanteric and sub-trochanteric fracture and the surgery is planned within 7 days after admission
- Patients, who are eligible for thromboprophylaxis. Such patients will be enrolled only after physician's decision to prescribe rivaroxaban for thromboprophylaxis has been made. The decision is totally based on standard of medical practice.
- Patients, who agree to participate, return to follow-up visits, and who have signed informed consent to participate in the study.
Exclusion
- Trauma affecting more than 1 organ system
- Pathological fracture secondary to malignant disease
- Clinically significant bleeding excluding drainage
- Documented congenital or acquired bleeding disorder
- Patients, who have contraindications for thromboprophylaxis or contraindications to take rivaroxaban according to FDA-approved product label
- Patient on oral anticoagulation therapy in the past 7 days
- Pregnancy or breastfeeding
- Patients who are simultaneously participating in a different study
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01509118
Start Date
July 1 2011
End Date
September 1 2013
Last Update
January 12 2012
Active Locations (7)
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1
Orthopedic/Board of Orthopedic Surgery, Saint Louis Hospital
Bangkok, Bangkok, Thailand, 10120
2
Department of Orthopedic Surgery, Bhumibol Adulyadej Hospital
Bangkok, Bangkok, Thailand, 10220
3
Department of Orthopaedics, Chulalongkorn Hospital
Pathumwan, Bangkok, Thailand, 10330
4
Department of Orthopedic Surgery, Police General Hospital
Pathumwan, Bangkok, Thailand, 10400