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

January 11, 2012 updated by: Dr.Thanainit Chotanaphuti, Phramongkutklao College of Medicine and Hospital
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10120
        • Recruiting
        • Orthopedic/Board of Orthopedic Surgery, Saint Louis Hospital
        • Contact:
        • Principal Investigator:
          • Thanin Santhanavanich, MD.
      • Bangkok, Thailand, 10220
        • Not yet recruiting
        • Department of Orthopedic Surgery, Bhumibol Adulyadej Hospital
        • Contact:
          • Thana Narinsorasak, MD.
          • Phone Number: 27365 662 5347000
        • Principal Investigator:
          • Thana Narinsorasak, MD.
    • Bangkok
      • Pathumwan, Bangkok, Thailand, 10330
        • Recruiting
        • Department of Orthopaedics, Chulalongkorn Hospital
        • Contact:
        • Principal Investigator:
          • Aree Tanavalee, M.D.
      • Pathumwan, Bangkok, Thailand, 10400
        • Recruiting
        • Department of Orthopedic Surgery, Police General Hospital
        • Contact:
        • Principal Investigator:
          • Thana Turajane, MD.
      • Rajathevee, Bangkok, Thailand, 10400
        • Recruiting
        • Department of Orthopaedic surgery Pharmongkutklao Hospital
        • Contact:
        • Principal Investigator:
          • Thanainit Chotanaphut, M.D.
    • Chiang Mai
      • Muang, Chiang Mai, Thailand, 50200
        • Recruiting
        • Department of Orthopaedic Surgery,Chiang Mai University
        • Contact:
        • Principal Investigator:
          • Prasit Wongtriratanachai, MD.
    • Pathumthani
      • Klong Luang, Pathumthani, Thailand, 12121
        • Recruiting
        • Department of Orthopaedics, Thammasat University
        • Contact:
        • Principal Investigator:
          • Boonchana Pongcharoen, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Rivaroxaban safety profile will be observed in 500 patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phramongkutklao College of Medicine and Hospital

Collaborators

Chulalongkorn University
Chiang Mai University
Thammasat University
Police General Hospital
Bhumibol Adulyadej Hospital
Saint Louis Hospital,bangkok,Thailand

Investigators

  • Principal Investigator: Thanainit Chotanaphut, M.D., Department of Orthopaedic surgery Pharmongkutklao Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

January 8, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Estimate)

January 12, 2012

Last Update Submitted That Met QC Criteria

January 11, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15635

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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