Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Phramongkutklao College of Medicine and Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Chulalongkorn University
Chiang Mai University
Thammasart University
Police General Hospital
Saint Louis Hospital,bangkok,Thailand
Bhumibol Adulyadej Hospital
Information provided by (Responsible Party):
Dr.Thanainit Chotanaphuti, Phramongkutklao College of Medicine and Hospital
ClinicalTrials.gov Identifier:
NCT01509118
First received: January 8, 2012
Last updated: January 11, 2012
Last verified: January 2012

January 8, 2012
January 11, 2012
July 2011
June 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01509118 on ClinicalTrials.gov Archive Site
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Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery
Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Rivaroxaban safety profile will be observed in 500 patients

Open Fracture of Hip
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
September 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Not Provided
Thailand
 
NCT01509118
15635
No
Dr.Thanainit Chotanaphuti, Phramongkutklao College of Medicine and Hospital
Phramongkutklao College of Medicine and Hospital
  • Chulalongkorn University
  • Chiang Mai University
  • Thammasart University
  • Police General Hospital
  • Saint Louis Hospital,bangkok,Thailand
  • Bhumibol Adulyadej Hospital
Principal Investigator: Thanainit Chotanaphut, M.D. Department of Orthopaedic Surgery Pharmongkutklao Hospital
Phramongkutklao College of Medicine and Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP