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Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement

Primary Purpose

Arthroplasty, Replacement, Knee, Thromboembolism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dabigatran Dose 1 - day 2 to completion
Dabigatran Dose 1 - day 1
Dabigatran Dose 2 - day 2 to completion
Dabigatran Dose 2 - day 1
Enoxaparin
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthroplasty, Replacement, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria INCLUSION CRITERIA Patients scheduled to undergo a primary, unilateral elective total knee repla cement. Male or female 18 years of age or older. Patients weighing at least 40 kg. Written informed consent prior to the start of study participation. Exclusion criteria EXCLUSION CRITERIA History of bleeding diathesis. Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding. Major surgery or trauma (e.g. hip fracture) within the last 3 months. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months. Spinal or epidural anesthesia, for which more than 3 attempts (sticks) at placement were made, or the placement was traumatic. Please note that patients, who are not excluded under this criterion, are to have the catheter pulled at the completion of surgery. Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm. History of VTE or pre-existing condition requiring anticoagulant therapy. Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months. Gastric or duodenal ulcer within the last 6 months. Liver disease expected to have any potential impact on survival (e.g. hepatitis B or C, cirrhosis, but not Gilbert's syndrome or hepatitis A with complete recovery). Elevated AST or ALT >2x upper limit of normal, based on central lab results or local lab results within 1 month before enrollment. Known severe renal insufficiency (CrCl < 30 mL/min). In order to determine patient inclusion/exclusion, creatinine clearance (CrCl) needs to be calculated only if serum creatinine is elevated or renal insufficiency is suspected.

Sites / Locations

  • 1160.24.01074 Capstone Clinical Trials, Inc.
  • 1160.24.01079 West AL Research, Inc
  • 1160.24.01047 Tucson Orhtopaedic Institute
  • 1160.24.01025 Martin, Bowen, Hefley Knee and Sports
  • 1160.24.01053 OrthoArkansas, PA
  • 1160.24.01085 Martin, Bowen, Hefley Knee and Sports
  • 1160.24.01041 Core Orthopedic Medical Center
  • 1160.24.01034 Glendale Adventist Medical Center
  • 1160.24.01005 Scripps Clinical Ctr for Orthopedic Rsrch & Educ
  • 1160.24.01077 Long Beach VA Healthcare system
  • 1160.24.01064 Orthopedic Specialty Institute
  • 1160.24.01031 Colorodo Orthopedic Consultants, PC
  • 1160.24.01027 Advanced Orthopedic and Sports Medicine Specialists, PC
  • 1160.24.01023 Orthopedic Physicians of Colorado, PC
  • 1160.24.01020 Bay Pines VA Medical Center
  • 1160.24.01024 Pulmonary Associates of Brandon Clinical Research
  • 1160.24.01030 Alliance Research, Inc.
  • 1160.24.01039 Florida Orthopedic Associates
  • 1160.24.01036 Orthopaedic Associates of South Broward, PA
  • 1160.24.01010 MIMA Century Research Associates
  • 1160.24.01062 Miami Institute for Joint Reconstruction
  • 1160.24.01040 Southern Clinical Research Consultants
  • 1160.24.01067 Baptist Clinical Research
  • 1160.24.01001 Boehringer Ingelheim Investigational Site
  • 1160.24.01017 Boehringer Ingelheim Investigational Site
  • 1160.24.01019 Boehringer Ingelheim Investigational Site
  • 1160.24.01029 Coastal Medical Research
  • 1160.24.01038 James A. Haley VA Hospital
  • 1160.24.01063 Resurgens Orthopaedics
  • 1160.24.01072 Resurgeons Orthopedics
  • 1160.24.01056 Southern Orthopaedic Specialists
  • 1160.24.01028 Intermountain Research Center
  • 1160.24.01022 Iowa Orthopedic Clinic
  • 1160.24.01008 Bluegrass Orthopedic/Musculoskeletal Research, LLC
  • 1160.24.01070 Sinai Hospital of Baltimore
  • 1160.24.01007 Ortho Associates
  • 1160.24.01059 Rockhill Orthopaedics
  • 1160.24.01042 Center for Joint Care
  • 1160.24.01014 Charlotte Orthopedic Specialists
  • 1160.24.01035 Wellington Orthopedics and Sports Medicine
  • 1160.24.01006 VA Medical Center
  • 1160.24.01044 Tulsa Bone and Joint Associates
  • 1160.24.01002 The Orthopedic and Neurological Center of the Cascades
  • 1160.24.01046 Boehringer Ingelheim Investigational Site
  • 1160.24.01016
  • 1160.24.01073 Coastal Orthopedic Associates, PA
  • 1160.24.01032 Seton Medical Center
  • 1160.24.01003 Texas Orthopedic Associates
  • 1160.24.01090 VA Medical Center
  • 1160.24.01026 James Muntz, MD
  • 1160.24.01033 Bone and Joint Clinic of Houston
  • 1160.24.01076 Discovery Alliance
  • 1160.24.01018 Gill Research Center
  • 1160.24.01069 Correspondence and Pateint vists
  • 1160.24.01015 Unlimited Research, LP
  • 1160.24.01012 Anderson Orthopedic Clinic
  • 1160.24.01052 Swedish Medical Center
  • 1160.24.01057 Orthopedic Specialty Clinic of Spokane, PLLC
  • 1160.24.01082 MultiCare Health System
  • 1160.24.02031 University of Alberta Hospital
  • 1160.24.02036 2B2.37 Walter Mackenizie Centre
  • 1160.24.02024 Red Deer Regional Hospital
  • 1160.24.02032 Kelowna General Hospital
  • 1160.24.02034 Hematology/Oncology Research
  • 1160.24.02025 Grace General Hospital
  • 1160.24.02007 Orthopaedics 4NE
  • 1160.24.02027 Atlantic Health Sciences Corporation
  • 1160.24.02021 Rouge Valley Health System
  • 1160.24.02008 Orthopaedic Surgery
  • 1160.24.02016 Orthopaedic Surgery
  • 1160.24.02010 Joseph Brant Memorial Hospital
  • 1160.24.02001 73 Delhi Street
  • 1160.24.02014 565 Sanatorium Road
  • 1160.24.02004 Grand River Hospital
  • 1160.24.02028 NHS- Greater Niagara General Site
  • 1160.24.02022 Lakeridge Health Oshawa
  • 1160.24.02017 1053 Carling Avenue
  • 1160.24.02026 Ottawa Hospital - General Campus
  • 1160.24.02015 York Central Hospital Research
  • 1160.24.02009 2863 Ellesmere Road
  • 1160.24.02029 Niagara Health System St. Catharine's General Site
  • 1160.24.02003 46 General Hospital Drive
  • 1160.24.02033 Thunder Bay Regional Hospital
  • 1160.24.02002 Toronto East General Hospital Fracture Clinic
  • 1160.24.02023 North York General Hospital
  • 1160.24.02030 St. Joseph's Health Centre
  • 1160.24.02006 206-477 King Street
  • 1160.24.02035 Humber River Regional Hospital
  • 1160.24.02011 Windsor Regional Hospital
  • 1160.24.02012 Hotel Dieu Grace Hospital
  • 1160.24.02013 Queen Elizabeth Hospital
  • 1160.24.05009 Traumatologia, Planta Baja
  • 1160.24.05004
  • 1160.24.44001 Ravenscourt Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Dabigatran Dose 1

Dabigatran Dose 2

Enoxaparin

Arm Description

low dose regimen taken once daily

high dose regimen taken once daily

30 mg subcutaneously twice daily

Outcomes

Primary Outcome Measures

Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
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

Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
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
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Number of Participants With Pulmonary Embolism During Treatment Period
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
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
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
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.

Full Information

First Posted
September 8, 2005
Last Updated
April 22, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00152971
Brief Title
Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement
Official Title
A Phase III, Randomized, Parallel-group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens (75mg Day 1 Followed by 150 mg Day 2-completion, and 110 mg Day 1 Followed by 220 mg Day 2-completion) of Dabigatran Etexilate Administered Orally (Capsules), Compared to Enoxaparin 30 mg Twice a Day Subcutaneous for 12 - 15 Days in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Knee, Thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2615 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dabigatran Dose 1
Arm Type
Experimental
Arm Description
low dose regimen taken once daily
Arm Title
Dabigatran Dose 2
Arm Type
Experimental
Arm Description
high dose regimen taken once daily
Arm Title
Enoxaparin
Arm Type
Active Comparator
Arm Description
30 mg subcutaneously twice daily
Intervention Type
Drug
Intervention Name(s)
Dabigatran Dose 1 - day 2 to completion
Intervention Description
low dose regimen taken once daily
Intervention Type
Drug
Intervention Name(s)
Dabigatran Dose 1 - day 1
Intervention Description
low dose regimen taken once daily
Intervention Type
Drug
Intervention Name(s)
Dabigatran Dose 2 - day 2 to completion
Intervention Description
high dose regimen taken once daily
Intervention Type
Drug
Intervention Name(s)
Dabigatran Dose 2 - day 1
Intervention Description
high dose regimen taken once daily
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
30 mg subcutaneously twice daily
Primary Outcome Measure Information:
Title
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Description
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.
Time Frame
First administration until 12-15 days
Secondary Outcome Measure Information:
Title
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Description
Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Time Frame
First administration until 12-15 days
Title
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
Description
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Time Frame
First administration until 12-15 days
Title
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
Description
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Time Frame
First administration until 12-15 days
Title
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
Description
Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Time Frame
First administration until 12-15 days
Title
Number of Participants With Pulmonary Embolism During Treatment Period
Description
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
Time Frame
First administration until 12-15 days
Title
Number of Participants Who Died During Treatment Period
Description
All cause death, as adjudicated by the VTE events committee
Time Frame
First administration until 12-15 days
Title
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
Description
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).
Time Frame
3 months
Title
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
Description
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.
Time Frame
First administration until 12-15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria INCLUSION CRITERIA Patients scheduled to undergo a primary, unilateral elective total knee repla cement. Male or female 18 years of age or older. Patients weighing at least 40 kg. Written informed consent prior to the start of study participation. Exclusion criteria EXCLUSION CRITERIA History of bleeding diathesis. Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding. Major surgery or trauma (e.g. hip fracture) within the last 3 months. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months. Spinal or epidural anesthesia, for which more than 3 attempts (sticks) at placement were made, or the placement was traumatic. Please note that patients, who are not excluded under this criterion, are to have the catheter pulled at the completion of surgery. Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm. History of VTE or pre-existing condition requiring anticoagulant therapy. Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months. Gastric or duodenal ulcer within the last 6 months. Liver disease expected to have any potential impact on survival (e.g. hepatitis B or C, cirrhosis, but not Gilbert's syndrome or hepatitis A with complete recovery). Elevated AST or ALT >2x upper limit of normal, based on central lab results or local lab results within 1 month before enrollment. Known severe renal insufficiency (CrCl < 30 mL/min). In order to determine patient inclusion/exclusion, creatinine clearance (CrCl) needs to be calculated only if serum creatinine is elevated or renal insufficiency is suspected.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.24.01074 Capstone Clinical Trials, Inc.
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
1160.24.01079 West AL Research, Inc
City
Northport
State/Province
Alabama
Country
United States
Facility Name
1160.24.01047 Tucson Orhtopaedic Institute
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
1160.24.01025 Martin, Bowen, Hefley Knee and Sports
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
1160.24.01053 OrthoArkansas, PA
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
1160.24.01085 Martin, Bowen, Hefley Knee and Sports
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
1160.24.01041 Core Orthopedic Medical Center
City
Encinitas
State/Province
California
Country
United States
Facility Name
1160.24.01034 Glendale Adventist Medical Center
City
Glendale
State/Province
California
Country
United States
Facility Name
1160.24.01005 Scripps Clinical Ctr for Orthopedic Rsrch & Educ
City
La Jolla
State/Province
California
Country
United States
Facility Name
1160.24.01077 Long Beach VA Healthcare system
City
Long Beach
State/Province
California
Country
United States
Facility Name
1160.24.01064 Orthopedic Specialty Institute
City
Orange
State/Province
California
Country
United States
Facility Name
1160.24.01031 Colorodo Orthopedic Consultants, PC
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
1160.24.01027 Advanced Orthopedic and Sports Medicine Specialists, PC
City
Denver
State/Province
Colorado
Country
United States
Facility Name
1160.24.01023 Orthopedic Physicians of Colorado, PC
City
Engelwood
State/Province
Colorado
Country
United States
Facility Name
1160.24.01020 Bay Pines VA Medical Center
City
Bay Pines
State/Province
Florida
Country
United States
Facility Name
1160.24.01024 Pulmonary Associates of Brandon Clinical Research
City
Brandon
State/Province
Florida
Country
United States
Facility Name
1160.24.01030 Alliance Research, Inc.
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
1160.24.01039 Florida Orthopedic Associates
City
Deland
State/Province
Florida
Country
United States
Facility Name
1160.24.01036 Orthopaedic Associates of South Broward, PA
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
1160.24.01010 MIMA Century Research Associates
City
Melbourne
State/Province
Florida
Country
United States
Facility Name
1160.24.01062 Miami Institute for Joint Reconstruction
City
Miami
State/Province
Florida
Country
United States
Facility Name
1160.24.01040 Southern Clinical Research Consultants
City
Orlando
State/Province
Florida
Country
United States
Facility Name
1160.24.01067 Baptist Clinical Research
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
1160.24.01001 Boehringer Ingelheim Investigational Site
City
Pinellas Park
State/Province
Florida
Country
United States
Facility Name
1160.24.01017 Boehringer Ingelheim Investigational Site
City
Pinellas Park
State/Province
Florida
Country
United States
Facility Name
1160.24.01019 Boehringer Ingelheim Investigational Site
City
Pinellas Park
State/Province
Florida
Country
United States
Facility Name
1160.24.01029 Coastal Medical Research
City
Port Orange
State/Province
Florida
Country
United States
Facility Name
1160.24.01038 James A. Haley VA Hospital
City
Tampa
State/Province
Florida
Country
United States
Facility Name
1160.24.01063 Resurgens Orthopaedics
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
1160.24.01072 Resurgeons Orthopedics
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
1160.24.01056 Southern Orthopaedic Specialists
City
Lawrencville
State/Province
Georgia
Country
United States
Facility Name
1160.24.01028 Intermountain Research Center
City
Boise
State/Province
Idaho
Country
United States
Facility Name
1160.24.01022 Iowa Orthopedic Clinic
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
1160.24.01008 Bluegrass Orthopedic/Musculoskeletal Research, LLC
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
1160.24.01070 Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
1160.24.01007 Ortho Associates
City
Towson
State/Province
Maryland
Country
United States
Facility Name
1160.24.01059 Rockhill Orthopaedics
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
1160.24.01042 Center for Joint Care
City
Missoula
State/Province
Montana
Country
United States
Facility Name
1160.24.01014 Charlotte Orthopedic Specialists
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
1160.24.01035 Wellington Orthopedics and Sports Medicine
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1160.24.01006 VA Medical Center
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
1160.24.01044 Tulsa Bone and Joint Associates
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
1160.24.01002 The Orthopedic and Neurological Center of the Cascades
City
Bend
State/Province
Oregon
Country
United States
Facility Name
1160.24.01046 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1160.24.01016
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1160.24.01073 Coastal Orthopedic Associates, PA
City
Conway
State/Province
South Carolina
Country
United States
Facility Name
1160.24.01032 Seton Medical Center
City
Austin
State/Province
Texas
Country
United States
Facility Name
1160.24.01003 Texas Orthopedic Associates
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1160.24.01090 VA Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1160.24.01026 James Muntz, MD
City
Houston
State/Province
Texas
Country
United States
Facility Name
1160.24.01033 Bone and Joint Clinic of Houston
City
Houston
State/Province
Texas
Country
United States
Facility Name
1160.24.01076 Discovery Alliance
City
Houston
State/Province
Texas
Country
United States
Facility Name
1160.24.01018 Gill Research Center
City
Lubbock
State/Province
Texas
Country
United States
Facility Name
1160.24.01069 Correspondence and Pateint vists
City
Plano
State/Province
Texas
Country
United States
Facility Name
1160.24.01015 Unlimited Research, LP
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1160.24.01012 Anderson Orthopedic Clinic
City
Alexandria
State/Province
Virginia
Country
United States
Facility Name
1160.24.01052 Swedish Medical Center
City
Seattle
State/Province
Washington
Country
United States
Facility Name
1160.24.01057 Orthopedic Specialty Clinic of Spokane, PLLC
City
Spokane
State/Province
Washington
Country
United States
Facility Name
1160.24.01082 MultiCare Health System
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
1160.24.02031 University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1160.24.02036 2B2.37 Walter Mackenizie Centre
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1160.24.02024 Red Deer Regional Hospital
City
Red Deer
State/Province
Alberta
Country
Canada
Facility Name
1160.24.02032 Kelowna General Hospital
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
1160.24.02034 Hematology/Oncology Research
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1160.24.02025 Grace General Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
1160.24.02007 Orthopaedics 4NE
City
Fredericton
State/Province
New Brunswick
Country
Canada
Facility Name
1160.24.02027 Atlantic Health Sciences Corporation
City
Saint John
State/Province
New Brunswick
Country
Canada
Facility Name
1160.24.02021 Rouge Valley Health System
City
Ajax
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02008 Orthopaedic Surgery
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02016 Orthopaedic Surgery
City
Brantford
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02010 Joseph Brant Memorial Hospital
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02001 73 Delhi Street
City
Guelph
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02014 565 Sanatorium Road
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02004 Grand River Hospital
City
Kitchener
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02028 NHS- Greater Niagara General Site
City
Niagara Falls
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02022 Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02017 1053 Carling Avenue
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02026 Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02015 York Central Hospital Research
City
Richmond Hill
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02009 2863 Ellesmere Road
City
Scarborough
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02029 Niagara Health System St. Catharine's General Site
City
St. Catherine's
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02003 46 General Hospital Drive
City
Stratford
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02033 Thunder Bay Regional Hospital
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02002 Toronto East General Hospital Fracture Clinic
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02023 North York General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02030 St. Joseph's Health Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02006 206-477 King Street
City
Welland
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02035 Humber River Regional Hospital
City
Weston
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02011 Windsor Regional Hospital
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02012 Hotel Dieu Grace Hospital
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
1160.24.02013 Queen Elizabeth Hospital
City
Charlottetown
State/Province
Prince Edward Island
Country
Canada
Facility Name
1160.24.05009 Traumatologia, Planta Baja
City
Guadalajara, Jalisco
Country
Mexico
Facility Name
1160.24.05004
City
México
Country
Mexico
Facility Name
1160.24.44001 Ravenscourt Park Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22709460
Citation
Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.24_U06-1616.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.24_literature.pdf
Description
Related Info

Learn more about this trial

Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement

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