Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery
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Purpose
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.
| Condition |
|---|
|
Open Fracture of Hip |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery |
| Estimated Enrollment: | 500 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Rivaroxaban safety profile will be observed in 500 patients
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations| Thailand | |
| Department of Orthopaedics, Chulalongkorn Hospital | Recruiting |
| Pathumwan, Bangkok, Thailand, 10330 | |
| Contact: Aree Tanavalee, MD. 662-256-4212 areetana@hotmail.com | |
| Principal Investigator: Aree Tanavalee, M.D. | |
| Department of Orthopedic Surgery, Police General Hospital | Recruiting |
| Pathumwan, Bangkok, Thailand, 10400 | |
| Contact: Thana Turajane, MD. 662 3193025 thanaturajane@yahoo.com | |
| Principal Investigator: Thana Turajane, MD. | |
| Department of Orthopaedic surgery Pharmongkutklao Hospital | Recruiting |
| Rajathevee, Bangkok, Thailand, 10400 | |
| Contact: Thanainit Chotanaphut, M.D. 662 3547600 ext 93504 me-pmk@hotmail.com | |
| Principal Investigator: Thanainit Chotanaphut, M.D. | |
| Department of Orthopaedic Surgery,Chiang Mai University | Recruiting |
| Muang, Chiang Mai, Thailand, 50200 | |
| Contact: Prasit Wongtriratanachai, MD. 66-5394-5544 prasitjo@gmail.com | |
| Principal Investigator: Prasit Wongtriratanachai, MD. | |
| Department of Orthopaedics, Thammasat University | Recruiting |
| Klong Luang, Pathumthani, Thailand, 12121 | |
| Contact: Boonchana Pongcharoen, MD. 662 9269775 boonbigbear@hotmail.com | |
| Principal Investigator: Boonchana Pongcharoen, MD. | |
| Department of Orthopedic Surgery, Bhumibol Adulyadej Hospital | Not yet recruiting |
| Bangkok, Thailand, 10220 | |
| Contact: Thana Narinsorasak, MD. 662 5347000 ext 27365 | |
| Principal Investigator: Thana Narinsorasak, MD. | |
| Orthopedic/Board of Orthopedic Surgery, Saint Louis Hospital | Recruiting |
| Bangkok, Thailand, 10120 | |
| Contact: Thanin Santhanavanich, MD. 662 210 9999 thanin@saintlouis.or.th | |
| Principal Investigator: Thanin Santhanavanich, MD. | |
| Principal Investigator: | Thanainit Chotanaphut, M.D. | Department of Orthopaedic Surgery Pharmongkutklao Hospital |
More Information
No publications provided
| Responsible Party: | Dr.Thanainit Chotanaphuti, Colonel, Phramongkutklao College of Medicine and Hospital |
| ClinicalTrials.gov Identifier: | NCT01509118 History of Changes |
| Other Study ID Numbers: | 15635 |
| Study First Received: | January 8, 2012 |
| Last Updated: | January 11, 2012 |
| Health Authority: | Thailand: Ethical Committee |
Additional relevant MeSH terms:
|
Fractures, Bone Fractures, Open Hip Fractures Thromboembolism Venous Thromboembolism Venous Thrombosis Wounds and Injuries |
Femoral Fractures Hip Injuries Leg Injuries Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis |
ClinicalTrials.gov processed this record on June 17, 2013