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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 thromboembolism (VTE) without thromboprophylaxis. In the absence of prophylaxis, the incidence of fatal pulmonary embolism (PE) after Hip Fracture Surgery (HFS) is reportedly 4%-12%. Provision of thromboprophylaxis to all patients who undergo HFS is recommended.
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 the amplified burst of thrombin generation and may result in more effective inhibition of thrombus formation with a favorable safety profile. In Thailand rivaroxaban is indicated for the prevention of VTE in patients undergoing major orthopedic surgery of the lower limbs including surgery for hip fractures. There are limited number of observational studies of rivaroxaban in thromboembolism after hip fracture surgery as the approved indication in most countries are for thromboprophylaxis in hip and knee arthroplasty. The broader indications and the high number of hip fracture surgeries in Thailand allow us to explore a pattern of safety profile particularly bleeding complications and risk factors in patients receiving rivaroxaban thromboprophylaxis after hip fracture surgery.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
Orthopedic/Board of Orthopedic Surgery, Saint Louis Hospital
Bangkok, Bangkok, Thailand
Department of Orthopedic Surgery, Bhumibol Adulyadej Hospital
Bangkok, Bangkok, Thailand
Department of Orthopaedics, Chulalongkorn Hospital
Pathumwan, Bangkok, Thailand
Department of Orthopedic Surgery, Police General Hospital
Pathumwan, Bangkok, Thailand
Department of Orthopaedic surgery Pharmongkutklao Hospital
Rajathevee, Bangkok, Thailand
Department of Orthopaedics, Thammasat University
Klong Luang, Changwat Pathum Thani, Thailand
Department of Orthopaedic Surgery,Chiang Mai University
Muang, Chiang Mai, Thailand
Start Date
July 1, 2011
Primary Completion Date
June 1, 2013
Completion Date
September 1, 2013
Last Updated
January 12, 2012
500
ESTIMATED participants
Lead Sponsor
Phramongkutklao College of Medicine and Hospital
Collaborators
Data Source & Attribution
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