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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Phramongkutklao College of Medicine and Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Chulalongkorn University
Chiang Mai University
Thammasat 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
  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

Resource links provided by NLM:


Further study details as provided by Phramongkutklao College of Medicine and Hospital:

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)
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 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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Rivaroxaban safety profile will be observed in 500 patients
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509118

Locations
Thailand
Department of Orthopaedics, Chulalongkorn Hospital
Pathumwan, Bangkok, Thailand, 10330
Department of Orthopedic Surgery, Police General Hospital
Pathumwan, Bangkok, Thailand, 10400
Department of Orthopaedic surgery Pharmongkutklao Hospital
Rajathevee, Bangkok, Thailand, 10400
Department of Orthopaedic Surgery,Chiang Mai University
Muang, Chiang Mai, Thailand, 50200
Department of Orthopaedics, Thammasat University
Klong Luang, Pathumthani, Thailand, 12121
Orthopedic/Board of Orthopedic Surgery, Saint Louis Hospital
Bangkok, Thailand, 10120
Department of Orthopedic Surgery, Bhumibol Adulyadej Hospital
Bangkok, Thailand, 10220
Sponsors and Collaborators
Phramongkutklao College of Medicine and Hospital
Chulalongkorn University
Chiang Mai University
Thammasat University
Police General Hospital
Saint Louis Hospital,bangkok,Thailand
Bhumibol Adulyadej Hospital
Investigators
Principal Investigator: Thanainit Chotanaphut, M.D. Department of Orthopaedic Surgery Pharmongkutklao Hospital
  More Information

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
Venous Thromboembolism
Thromboembolism
Hip Fractures
Fractures, Open
Wounds and Injuries
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Femoral Fractures
Hip Injuries
Leg Injuries
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants

ClinicalTrials.gov processed this record on December 02, 2016