Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement
- Conditions
- Arthroplasty, Replacement, KneeThromboembolism
- Interventions
- Registration Number
- NCT00152971
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2615
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dabigatran Dose 2 Dabigatran Dose 2 - day 1 high dose regimen taken once daily Dabigatran Dose 1 Dabigatran Dose 1 - day 2 to completion low dose regimen taken once daily Dabigatran Dose 1 Dabigatran Dose 1 - day 1 low dose regimen taken once daily Dabigatran Dose 2 Dabigatran Dose 2 - day 2 to completion high dose regimen taken once daily Enoxaparin Enoxaparin 30 mg subcutaneously twice daily
- Primary Outcome Measures
Name Time Method Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period First administration until 12-15 days Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.
- Secondary Outcome Measures
Name Time Method Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period First administration until 12-15 days Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period First administration until 12-15 days Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period First administration until 12-15 days Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Number of Participants With Total Deep Vein Thrombosis During Treatment Period First administration until 12-15 days Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Number of Participants With Pulmonary Embolism During Treatment Period First administration until 12-15 days Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee
Number of Participants Who Died During Treatment Period First administration until 12-15 days All cause death, as adjudicated by the VTE events committee
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period 3 months Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period First administration until 12-15 days Major bleeding events were defined as
* fatal
* clinically overt associated with loss of haemoglobin \>=20g/L in excess of what was expected
* clinically overt leading to the transfusion of \>=2 units packed cells or whole blood in excess of what was expected
* symptomatic retroperitoneal, intracranial, intraocular or intraspinal
* requiring treatment cessation
* leading to re-operation
Clinically-relevant was defined as
* spontaneous skin hematoma greater than or equal to 25 cm²
* wound hematoma greater than or equal to 100 cm²
* spontaneous nose bleed lasting longer than 5 min
* macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
* spontaneous rectal bleeding (more than a spot on toilet paper)
* gingival bleeding lasting longer than 5 min
* any other bleeding event considered clinically relevant by the investigator
Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
Trial Locations
- Locations (94)
1160.24.05009 Traumatologia, Planta Baja
🇲🇽Guadalajara, Jalisco, Mexico
1160.24.01010 MIMA Century Research Associates
🇺🇸Melbourne, Florida, United States
1160.24.01033 Bone and Joint Clinic of Houston
🇺🇸Houston, Texas, United States
1160.24.01063 Resurgens Orthopaedics
🇺🇸Atlanta, Georgia, United States
1160.24.01070 Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
1160.24.01046 Boehringer Ingelheim Investigational Site
🇺🇸Philadelphia, Pennsylvania, United States
1160.24.01052 Swedish Medical Center
🇺🇸Seattle, Washington, United States
1160.24.01072 Resurgeons Orthopedics
🇺🇸Atlanta, Georgia, United States
1160.24.01076 Discovery Alliance
🇺🇸Houston, Texas, United States
1160.24.02022 Lakeridge Health Oshawa
🇨🇦Oshawa, Ontario, Canada
1160.24.01090 VA Medical Center
🇺🇸Dallas, Texas, United States
1160.24.02027 Atlantic Health Sciences Corporation
🇨🇦Saint John, New Brunswick, Canada
1160.24.02002 Toronto East General Hospital Fracture Clinic
🇨🇦Toronto, Ontario, Canada
1160.24.02023 North York General Hospital
🇨🇦Toronto, Ontario, Canada
1160.24.02030 St. Joseph's Health Centre
🇨🇦Toronto, Ontario, Canada
1160.24.02025 Grace General Hospital
🇨🇦Winnipeg, Manitoba, Canada
1160.24.01074 Capstone Clinical Trials, Inc.
🇺🇸Birmingham, Alabama, United States
1160.24.01027 Advanced Orthopedic and Sports Medicine Specialists, PC
🇺🇸Denver, Colorado, United States
1160.24.01006 VA Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
1160.24.01079 West AL Research, Inc
🇺🇸Northport, Alabama, United States
1160.24.01053 OrthoArkansas, PA
🇺🇸Little Rock, Arkansas, United States
1160.24.01005 Scripps Clinical Ctr for Orthopedic Rsrch & Educ
🇺🇸La Jolla, California, United States
1160.24.01024 Pulmonary Associates of Brandon Clinical Research
🇺🇸Brandon, Florida, United States
1160.24.01077 Long Beach VA Healthcare system
🇺🇸Long Beach, California, United States
1160.24.01039 Florida Orthopedic Associates
🇺🇸Deland, Florida, United States
1160.24.01017 Boehringer Ingelheim Investigational Site
🇺🇸Pinellas Park, Florida, United States
1160.24.01019 Boehringer Ingelheim Investigational Site
🇺🇸Pinellas Park, Florida, United States
1160.24.01008 Bluegrass Orthopedic/Musculoskeletal Research, LLC
🇺🇸Lexington, Kentucky, United States
1160.24.01014 Charlotte Orthopedic Specialists
🇺🇸Charlotte, North Carolina, United States
1160.24.01007 Ortho Associates
🇺🇸Towson, Maryland, United States
1160.24.01035 Wellington Orthopedics and Sports Medicine
🇺🇸Cincinnati, Ohio, United States
1160.24.01002 The Orthopedic and Neurological Center of the Cascades
🇺🇸Bend, Oregon, United States
1160.24.01018 Gill Research Center
🇺🇸Lubbock, Texas, United States
1160.24.01026 James Muntz, MD
🇺🇸Houston, Texas, United States
1160.24.01015 Unlimited Research, LP
🇺🇸San Antonio, Texas, United States
1160.24.01038 James A. Haley VA Hospital
🇺🇸Tampa, Florida, United States
1160.24.02010 Joseph Brant Memorial Hospital
🇨🇦Burlington, Ontario, Canada
1160.24.01036 Orthopaedic Associates of South Broward, PA
🇺🇸Hollywood, Florida, United States
1160.24.01044 Tulsa Bone and Joint Associates
🇺🇸Tulsa, Oklahoma, United States
1160.24.01025 Martin, Bowen, Hefley Knee and Sports
🇺🇸Little Rock, Arkansas, United States
1160.24.01085 Martin, Bowen, Hefley Knee and Sports
🇺🇸Little Rock, Arkansas, United States
1160.24.01034 Glendale Adventist Medical Center
🇺🇸Glendale, California, United States
1160.24.01041 Core Orthopedic Medical Center
🇺🇸Encinitas, California, United States
1160.24.01064 Orthopedic Specialty Institute
🇺🇸Orange, California, United States
1160.24.01020 Bay Pines VA Medical Center
🇺🇸Bay Pines, Florida, United States
1160.24.01023 Orthopedic Physicians of Colorado, PC
🇺🇸Engelwood, Colorado, United States
1160.24.01030 Alliance Research, Inc.
🇺🇸Clearwater, Florida, United States
1160.24.01062 Miami Institute for Joint Reconstruction
🇺🇸Miami, Florida, United States
1160.24.01067 Baptist Clinical Research
🇺🇸Pensacola, Florida, United States
1160.24.01001 Boehringer Ingelheim Investigational Site
🇺🇸Pinellas Park, Florida, United States
1160.24.01029 Coastal Medical Research
🇺🇸Port Orange, Florida, United States
1160.24.01056 Southern Orthopaedic Specialists
🇺🇸Lawrencville, Georgia, United States
1160.24.01028 Intermountain Research Center
🇺🇸Boise, Idaho, United States
1160.24.01022 Iowa Orthopedic Clinic
🇺🇸Des Moines, Iowa, United States
1160.24.01042 Center for Joint Care
🇺🇸Missoula, Montana, United States
1160.24.01032 Seton Medical Center
🇺🇸Austin, Texas, United States
1160.24.01073 Coastal Orthopedic Associates, PA
🇺🇸Conway, South Carolina, United States
1160.24.01003 Texas Orthopedic Associates
🇺🇸Dallas, Texas, United States
1160.24.01069 Correspondence and Pateint vists
🇺🇸Plano, Texas, United States
1160.24.01057 Orthopedic Specialty Clinic of Spokane, PLLC
🇺🇸Spokane, Washington, United States
1160.24.01012 Anderson Orthopedic Clinic
🇺🇸Alexandria, Virginia, United States
1160.24.02024 Red Deer Regional Hospital
🇨🇦Red Deer, Alberta, Canada
1160.24.02036 2B2.37 Walter Mackenizie Centre
🇨🇦Edmonton, Alberta, Canada
1160.24.02031 University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
1160.24.01082 MultiCare Health System
🇺🇸Tacoma, Washington, United States
1160.24.02007 Orthopaedics 4NE
🇨🇦Fredericton, New Brunswick, Canada
1160.24.02032 Kelowna General Hospital
🇨🇦Kelowna, British Columbia, Canada
1160.24.02034 Hematology/Oncology Research
🇨🇦Vancouver, British Columbia, Canada
1160.24.02001 73 Delhi Street
🇨🇦Guelph, Ontario, Canada
1160.24.02021 Rouge Valley Health System
🇨🇦Ajax, Ontario, Canada
1160.24.02008 Orthopaedic Surgery
🇨🇦Barrie, Ontario, Canada
1160.24.02016 Orthopaedic Surgery
🇨🇦Brantford, Ontario, Canada
1160.24.02004 Grand River Hospital
🇨🇦Kitchener, Ontario, Canada
1160.24.02014 565 Sanatorium Road
🇨🇦Hamilton, Ontario, Canada
1160.24.02028 NHS- Greater Niagara General Site
🇨🇦Niagara Falls, Ontario, Canada
1160.24.02017 1053 Carling Avenue
🇨🇦Ottawa, Ontario, Canada
1160.24.02029 Niagara Health System St. Catharine's General Site
🇨🇦St. Catherine's, Ontario, Canada
1160.24.02026 Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada
1160.24.02015 York Central Hospital Research
🇨🇦Richmond Hill, Ontario, Canada
1160.24.02003 46 General Hospital Drive
🇨🇦Stratford, Ontario, Canada
1160.24.02009 2863 Ellesmere Road
🇨🇦Scarborough, Ontario, Canada
1160.24.02033 Thunder Bay Regional Hospital
🇨🇦Thunder Bay, Ontario, Canada
1160.24.02012 Hotel Dieu Grace Hospital
🇨🇦Windsor, Ontario, Canada
1160.24.02006 206-477 King Street
🇨🇦Welland, Ontario, Canada
1160.24.02011 Windsor Regional Hospital
🇨🇦Windsor, Ontario, Canada
1160.24.02035 Humber River Regional Hospital
🇨🇦Weston, Ontario, Canada
1160.24.05004
🇲🇽México, Mexico
1160.24.02013 Queen Elizabeth Hospital
🇨🇦Charlottetown, Prince Edward Island, Canada
1160.24.44001 Ravenscourt Park Hospital
🇬🇧London, United Kingdom
1160.24.01031 Colorodo Orthopedic Consultants, PC
🇺🇸Aurora, Colorado, United States
1160.24.01040 Southern Clinical Research Consultants
🇺🇸Orlando, Florida, United States
1160.24.01059 Rockhill Orthopaedics
🇺🇸Kansas City, Missouri, United States
1160.24.01016
🇺🇸Charleston, South Carolina, United States
1160.24.01047 Tucson Orhtopaedic Institute
🇺🇸Tucson, Arizona, United States