Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT01509118
Status:
UNKNOWN
Last Update Posted:
2012-01-12
First Post:
2012-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-11', 'studyFirstSubmitDate': '2012-01-08', 'studyFirstSubmitQcDate': '2012-01-11', 'lastUpdatePostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Open Fracture of Hip']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Rivaroxaban safety profile will be observed in 500 patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 50 years old in men or post-menopause in women\n* 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\n* 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.\n* Patients, who agree to participate, return to follow-up visits, and who have signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Trauma affecting more than 1 organ system\n* Pathological fracture secondary to malignant disease\n* Clinically significant bleeding excluding drainage\n* Documented congenital or acquired bleeding disorder\n* Patients, who have contraindications for thromboprophylaxis or contraindications to take rivaroxaban according to FDA-approved product label\n* Patient on oral anticoagulation therapy in the past 7 days\n* Pregnancy or breastfeeding\n* Patients who are simultaneously participating in a different study"}, 'identificationModule': {'nctId': 'NCT01509118', 'briefTitle': 'Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Phramongkutklao College of Medicine and Hospital'}, 'officialTitle': 'Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery', 'orgStudyIdInfo': {'id': '15635'}}, 'contactsLocationsModule': {'locations': [{'zip': '10120', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Thanin Santhanavanich, MD.', 'role': 'CONTACT', 'email': 'thanin@saintlouis.or.th', 'phone': '662 210 9999'}, {'name': 'Thanin Santhanavanich, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orthopedic/Board of Orthopedic Surgery, Saint Louis Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10220', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'NOT_YET_RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Thana Narinsorasak, MD.', 'role': 'CONTACT', 'phone': '662 5347000', 'phoneExt': '27365'}, {'name': 'Thana Narinsorasak, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Orthopedic Surgery, Bhumibol Adulyadej Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10330', 'city': 'Pathumwan', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Aree Tanavalee, MD.', 'role': 'CONTACT', 'email': 'areetana@hotmail.com', 'phone': '662-256-4212'}, {'name': 'Aree Tanavalee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Orthopaedics, Chulalongkorn Hospital'}, {'zip': '10400', 'city': 'Pathumwan', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Thana Turajane, MD.', 'role': 'CONTACT', 'email': 'thanaturajane@yahoo.com', 'phone': '662 3193025'}, {'name': 'Thana Turajane, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Orthopedic Surgery, Police General Hospital'}, {'zip': '10400', 'city': 'Rajathevee', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Thanainit Chotanaphut, M.D.', 'role': 'CONTACT', 'email': 'me-pmk@hotmail.com', 'phone': '662 3547600', 'phoneExt': '93504'}, {'name': 'Thanainit Chotanaphut, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Orthopaedic surgery Pharmongkutklao Hospital'}, {'zip': '12121', 'city': 'Klong Luang', 'state': 'Changwat Pathum Thani', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Boonchana Pongcharoen, MD.', 'role': 'CONTACT', 'email': 'boonbigbear@hotmail.com', 'phone': '662 9269775'}, {'name': 'Boonchana Pongcharoen, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Orthopaedics, Thammasat University'}, {'zip': '50200', 'city': 'Muang', 'state': 'Chiang Mai', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Prasit Wongtriratanachai, MD.', 'role': 'CONTACT', 'email': 'prasitjo@gmail.com', 'phone': '66-5394-5544'}, {'name': 'Prasit Wongtriratanachai, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Orthopaedic Surgery,Chiang Mai University'}], 'overallOfficials': [{'name': 'Thanainit Chotanaphut, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedic Surgery Pharmongkutklao Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phramongkutklao College of Medicine and Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chulalongkorn University', 'class': 'OTHER'}, {'name': 'Chiang Mai University', 'class': 'OTHER'}, {'name': 'Thammasat University', 'class': 'OTHER'}, {'name': 'Police General Hospital', 'class': 'OTHER'}, {'name': 'Saint Louis Hospital,bangkok,Thailand', 'class': 'UNKNOWN'}, {'name': 'Bhumibol Adulyadej Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Colonel', 'investigatorFullName': 'Dr.Thanainit Chotanaphuti', 'investigatorAffiliation': 'Phramongkutklao College of Medicine and Hospital'}}}}