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

NCT ID: NCT01509118

Last Updated: 2012-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Open Fracture of Hip

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role collaborator

Chiang Mai University

OTHER

Sponsor Role collaborator

Thammasat University

OTHER

Sponsor Role collaborator

Police General Hospital

OTHER

Sponsor Role collaborator

Saint Louis Hospital,bangkok,Thailand

UNKNOWN

Sponsor Role collaborator

Bhumibol Adulyadej Hospital

OTHER

Sponsor Role collaborator

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr.Thanainit Chotanaphuti

Colonel

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thanainit Chotanaphut, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedic Surgery Pharmongkutklao Hospital

Locations

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Orthopedic/Board of Orthopedic Surgery, Saint Louis Hospital

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Department of Orthopedic Surgery, Bhumibol Adulyadej Hospital

Bangkok, Bangkok, Thailand

Site Status NOT_YET_RECRUITING

Department of Orthopaedics, Chulalongkorn Hospital

Pathumwan, Bangkok, Thailand

Site Status RECRUITING

Department of Orthopedic Surgery, Police General Hospital

Pathumwan, Bangkok, Thailand

Site Status RECRUITING

Department of Orthopaedic surgery Pharmongkutklao Hospital

Rajathevee, Bangkok, Thailand

Site Status RECRUITING

Department of Orthopaedics, Thammasat University

Klong Luang, Changwat Pathum Thani, Thailand

Site Status RECRUITING

Department of Orthopaedic Surgery,Chiang Mai University

Muang, Chiang Mai, Thailand

Site Status RECRUITING

Countries

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Thailand

Facility Contacts

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Thanin Santhanavanich, MD.

Role: primary

[email protected]
662 210 9999

Thana Narinsorasak, MD.

Role: primary

662 5347000 ext. 27365

Aree Tanavalee, MD.

Role: primary

[email protected]
662-256-4212

Thana Turajane, MD.

Role: primary

[email protected]
662 3193025

Thanainit Chotanaphut, M.D.

Role: primary

[email protected]
662 3547600 ext. 93504

Boonchana Pongcharoen, MD.

Role: primary

[email protected]
662 9269775

Prasit Wongtriratanachai, MD.

Role: primary

[email protected]
66-5394-5544

Other Identifiers

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15635

Identifier Type: -

Identifier Source: org_study_id

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