Open Fracture of HipNCT01509118
Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery
An observational study of Open Fracture of Hip, run by Phramongkutklao College of Medicine and Hospital at 7 sites in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Open Fracture of Hip
- How many people
- 500 participants
- Where
- 7 sitesThailand
- Study dates
- Jul 2011to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rivaroxaban safety profile will be observed in 500 patients
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Thailand7 sites, 7 recruiting
- Recruiting
Orthopedic/Board of Orthopedic Surgery, Saint Louis Hospital
Bangkok, Bangkok, 10120
Thanin Santhanavanich, MD., 662 210 9999, thanin@saintlouis.or.th
Thanin Santhanavanich, MD.
- Not yet recruiting
Department of Orthopedic Surgery, Bhumibol Adulyadej Hospital
Bangkok, Bangkok, 10220
Thana Narinsorasak, MD., 662 5347000 ext. 27365
Thana Narinsorasak, MD.
- Recruiting
Department of Orthopaedics, Thammasat University
Klong Luang, Changwat Pathum Thani, 12121
Boonchana Pongcharoen, MD., 662 9269775, boonbigbear@hotmail.com
Boonchana Pongcharoen, MD.
- Recruiting
Department of Orthopaedic Surgery,Chiang Mai University
Muang, Chiang Mai, 50200
Prasit Wongtriratanachai, MD., 66-5394-5544, prasitjo@gmail.com
Prasit Wongtriratanachai, MD.
- Recruiting
Department of Orthopaedics, Chulalongkorn Hospital
Pathumwan, Bangkok, 10330
Aree Tanavalee, MD., 662-256-4212, areetana@hotmail.com
Aree Tanavalee, M.D.
- Recruiting
Department of Orthopedic Surgery, Police General Hospital
Pathumwan, Bangkok, 10400
Thana Turajane, MD., 662 3193025, thanaturajane@yahoo.com
Thana Turajane, MD.
- Recruiting
Department of Orthopaedic surgery Pharmongkutklao Hospital
Rajathevee, Bangkok, 10400
Thanainit Chotanaphut, M.D., 662 3547600 ext. 93504, me-pmk@hotmail.com
Thanainit Chotanaphut, M.D.
About this study
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.
Read the 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.
- Conditions
- Open Fracture of Hip
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJul 2011
- Primary completionJun 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Fracture of HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University, Chiang Mai University, Thammasat University, Police General Hospital, Saint Louis Hospital,bangkok,Thailand, Bhumibol Adulyadej Hospital
- Responsible party
- Principal investigator, Dr.Thanainit Chotanaphuti, Phramongkutklao College of Medicine and Hospital
- Investigators
- Thanainit Chotanaphut, M.D., Principal investigator, Department of Orthopaedic Surgery Pharmongkutklao Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509118
- Sponsor's protocol ID
- 15635
- Status last verified
- Jan 2012
- First submitted
- 8 Jan 2012
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT01509118
- Acronym / sponsor ID
- 15635
- Conditions
- Open Fracture of Hip
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Collaborators
- Chulalongkorn University, Chiang Mai University, Thammasat University, Police General Hospital, Saint Louis Hospital,bangkok,Thailand, Bhumibol Adulyadej Hospital
- Study start
- Jul 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rivaroxaban safety profile will be observed in 500 patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
Related trials for Open Fracture of Hip
Active, not recruitingObservational study
Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay
Primary Osteoarthritis, Secondary Osteoarthritis
Recruiting
Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial)
Anesthesia, Hip Fractures
RecruitingObservational study
Geriatric Acetabular fracTures: Open Reduction Internal Fixation Versus Replacement
Acetabular Fracture
Enrolling by invitation
Clinical Efficacy of Exoskeleton Robot-Assisted Rehabilitation on Lower Limb Functional Recovery in Elderly Patients With Hip Fracture
Hip Fracture, Geriatrics
Active, not recruiting
Open vs Closed Reduction in Femoral Neck Fractures Using Anterolateral vs Direct Lateral Approach
Femoral Neck Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orthopedic/Board of Orthopedic Surgery, Saint Louis Hospital
Bangkok, Thailand
Department of Orthopedic Surgery, Bhumibol Adulyadej Hospital
Bangkok, Thailand
Department of Orthopaedics, Chulalongkorn Hospital
Pathumwan, Thailand
Thanainit Chotanaphut, M.D. principal investigator
Department of Orthopaedic Surgery Pharmongkutklao Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Fracture of Hip, run by Phramongkutklao College of Medicine and Hospital at 7 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2012.