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CompletedNCT00152971Updated May 5, 2014Results posted

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

A Phase 3 interventional study of Dabigatran Dose 1 - day 2 to completion and Dabigatran Dose 1 - day 1 in Arthroplasty, Replacement, Knee and Thromboembolism, sponsored by Boehringer Ingelheim. Completed at 94 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-05.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,615
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Arthroplasty, Replacement, Knee
  • Thromboembolism
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's enrollment of 2,615 is above the median of 196 across 436 interventional studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients scheduled to undergo a primary, unilateral elective total knee repla cement.
  2. Male or female 18 years of age or older.
  3. Patients weighing at least 40 kg.
  4. Written informed consent prior to the start of study participation.

Exclusion criteria

Exclusion criteria EXCLUSION CRITERIA

  1. History of bleeding diathesis.
  2. Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding.
  3. Major surgery or trauma (e.g. hip fracture) within the last 3 months.
  4. 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.

  5. 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.

  6. Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm.
  7. History of VTE or pre-existing condition requiring anticoagulant therapy.
  8. Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months.
  9. Gastric or duodenal ulcer within the last 6 months.
  10. 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).
  11. Elevated AST or ALT >2x upper limit of normal, based on central lab results or local lab results within 1 month before enrollment.
  12. 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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
2,615 participants (actual)

Study arms

  • Experimental
    Dabigatran Dose 1

    low dose regimen taken once daily

    Drug: Dabigatran Dose 1 - day 2 to completion · Drug: Dabigatran Dose 1 - day 1

  • Experimental
    Dabigatran Dose 2

    high dose regimen taken once daily

    Drug: Dabigatran Dose 2 - day 2 to completion · Drug: Dabigatran Dose 2 - day 1

  • Active comparator
    Enoxaparin

    30 mg subcutaneously twice daily

    Drug: Enoxaparin

Interventions

  • DrugDabigatran Dose 1 - day 2 to completion

    low dose regimen taken once daily

  • DrugDabigatran Dose 1 - day 1

    low dose regimen taken once daily

  • DrugDabigatran Dose 2 - day 2 to completion

    high dose regimen taken once daily

  • DrugDabigatran Dose 2 - day 1

    high dose regimen taken once daily

  • DrugEnoxaparin

    30 mg subcutaneously twice daily

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: First administration until 12-15 days

Secondary outcomes

  1. 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

    Time frame: First administration until 12-15 days

  2. Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period

    Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee

    Time frame: First administration until 12-15 days

  3. Number of Participants With Total Deep Vein Thrombosis During Treatment Period

    Total Deep Vein Thrombosis as adjudicated by the VTE events committee

    Time frame: First administration until 12-15 days

  4. 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

    Time frame: First administration until 12-15 days

  5. 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

    Time frame: First administration until 12-15 days

  6. Number of Participants Who Died During Treatment Period

    All cause death, as adjudicated by the VTE events committee

    Time frame: First administration until 12-15 days

  7. 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).

    Time frame: 3 months

  8. 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.

    Time frame: First administration until 12-15 days

07

Results

Posted Dec 17, 2010

Participant flow

The treatment period is from first administration of study medication, until 3 days after last administration of study medication. Treatment duration is planned for 12 - 15 days. The study period is from first administration of study medication until day 84 - 91.

Participant flow — Overall Study
MilestoneDabigatran 220mgDabigatran 150mgEnoxaparin
Started857871868
Completed806823819
Not completed514849
Withdrew: Adverse event12109
Withdrew: Protocol violation10118
Withdrew: Lost to follow-up171413
Withdrew: Withdrawal by subject9814
Withdrew: Other355
Treatment
Participant flow — Treatment
MilestoneDabigatran 220mgDabigatran 150mgEnoxaparin
Started857871868
Completed786808788
Not completed716380
Withdrew: Adverse event494054
Withdrew: Protocol violation8610
Withdrew: Lost to follow-up121
Withdrew: Withdrawal by subject445
Withdrew: Other91110

Outcome measures

PrimaryNumber 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.

Time frame:
First administration until 12-15 days
Reported as:
Number · Participants
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
ParticipantsDabigatran 220mgDabigatran 150mgEnoxaparin
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period188219163
Statistical analysis
  • Dabigatran 220mg vs Enoxaparin · Normal approximation · p = 0.0234 (Hierarchical testing procedure: first non-inferiority, second superiority) · Risk difference (percentage): 5.8 · 95% CI 0.8 to 10.8Normal approximation of independent binomial distribution without stratification
  • Dabigatran 150mg vs Enoxaparin · Normal approximation · p = 0.0009 (Hierarchical testing procedure: first non-inferiority, second superiority) · Risk difference (percentage): 8.4 · 95% CI 3.4 to 13.3Normal approximation of independent binomial distribution without stratification
SecondaryNumber 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

Time frame:
First administration until 12-15 days
Reported as:
Number · Participants
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
ParticipantsDabigatran 220mgDabigatran 150mgEnoxaparin
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period212015
Statistical analysis
  • Dabigatran 220mg vs Enoxaparin · Normal approximation · p = 0.2139 · Risk difference (percentage): 1.2 · 95% CI -0.7 to 3.0Normal approximation of independent binomial distribution without stratification
  • Dabigatran 150mg vs Enoxaparin · Normal approximation · p = 0.3628 · Risk difference (percentage): 0.8 · 95% CI -0.9 to 2.5Normal approximation of independent binomial distribution without stratification
SecondaryNumber of Participants With Proximal Deep Vein Thrombosis During Treatment Period

Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee

Time frame:
First administration until 12-15 days
Reported as:
Number · Participants
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
ParticipantsDabigatran 220mgDabigatran 150mgEnoxaparin
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period152010
Statistical analysis
  • Dabigatran 220mg vs Enoxaparin · Normal approximation · p = 0.2309 · Risk difference (percentage): 0.9 · 95% CI -0.6 to 2.5Normal approximation of independent binomial distribution without stratification
  • Dabigatran 150mg vs Enoxaparin · Normal approximation · p = 0.0602 · Risk difference (percentage): 1.5 · 95% CI -0.1 to 3.2Normal approximation of independent binomial distribution without stratification
SecondaryNumber of Participants With Total Deep Vein Thrombosis During Treatment Period

Total Deep Vein Thrombosis as adjudicated by the VTE events committee

Time frame:
First administration until 12-15 days
Reported as:
Number · Participants
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
ParticipantsDabigatran 220mgDabigatran 150mgEnoxaparin
Number of Participants With Total Deep Vein Thrombosis During Treatment Period184218158
Statistical analysis
  • Dabigatran 220mg vs Enoxaparin · Normal approximation · p = 0.0194 · Risk difference (percentage): 5.9 · 95% CI 1.0 to 10.9Normal approximation of independent binomial distribution without stratification
  • Dabigatran 150mg vs Enoxaparin · Normal approximation · p = 0.0004 · Risk difference (percentage): 8.9 · 95% CI 4.0 to 13.9Normal approximation of independent binomial distribution without stratification
SecondaryNumber 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

Time frame:
First administration until 12-15 days
Reported as:
Number · Participants
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
ParticipantsDabigatran 220mgDabigatran 150mgEnoxaparin
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period765
Statistical analysis
  • Dabigatran 220mg vs Enoxaparin · Fisher Exact · p = 0.5774
  • Dabigatran 150mg vs Enoxaparin · Fisher Exact · p = 1.0000
SecondaryNumber 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

Time frame:
First administration until 12-15 days
Reported as:
Number · Participants
Number of Participants With Pulmonary Embolism During Treatment Period
ParticipantsDabigatran 220mgDabigatran 150mgEnoxaparin
Number of Participants With Pulmonary Embolism During Treatment Period605
Statistical analysis
  • Dabigatran 220mg vs Enoxaparin · Fisher Exact · p = 0.7724
  • Dabigatran 150mg vs Enoxaparin · Fisher Exact · p = 0.0308
SecondaryNumber of Participants Who Died During Treatment Period

All cause death, as adjudicated by the VTE events committee

Time frame:
First administration until 12-15 days
Reported as:
Number · Participants
Number of Participants Who Died During Treatment Period
ParticipantsDabigatran 220mgDabigatran 150mgEnoxaparin
Number of Participants Who Died During Treatment Period110
Statistical analysis
  • Dabigatran 220mg vs Enoxaparin · Fisher Exact · p = 0.4968
  • Dabigatran 150mg vs Enoxaparin · Fisher Exact · p = 1.0000
SecondaryNumber 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).

Time frame:
3 months
Reported as:
Number · Participants
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
ParticipantsDabigatran 220mgDabigatran 150mgEnoxaparin
Total VTE and all-cause mortality7710
asymptotic Deep Vein Thrombosis214
symptotic Deep Vein Thrombosis242
Pulmonary Embolism202
death122
SecondaryNumber 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.

Time frame:
First administration until 12-15 days
Reported as:
Number · Participants
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
ParticipantsDabigatran 220mgDabigatran 150mgEnoxaparin
Major5512
Clinically relevant232221
Minor464551
None783799784
Statistical analysis
  • Dabigatran 220mg vs Enoxaparin · Fisher Exact · p = 0.1416
  • Dabigatran 150mg vs Enoxaparin · Fisher Exact · p = 0.0942

Adverse events

Collected over First administration until (usually) day 21, i.e., treatment period + 3 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dabigatran 220mg—59/857 (6.9%)718/857 (83.8%)
Dabigatran 150mg—57/871 (6.5%)724/871 (83.1%)
Enoxaparin—45/868 (5.2%)711/868 (81.9%)
Most frequent serious events
Showing 10 of 118
Most frequent serious events
EventDabigatran 220mgDabigatran 150mgEnoxaparin
Deep vein thrombosisVascular disorders10/8579/8715/868
Atrial fibrillationCardiac disorders6/8572/8714/868
IleusGastrointestinal disorders5/8573/8710/868
Myocardial infarctionCardiac disorders0/8575/8712/868
Pulmonary embolismRespiratory, thoracic and mediastinal disorders4/8570/8713/868
Confusional statePsychiatric disorders3/8570/8710/868
Haemoglobin decreasedInvestigations1/8572/8713/868
AnaemiaBlood and lymphatic system disorders1/8573/8711/868
PyrexiaGeneral disorders0/8573/8712/868
CellulitisInfections and infestations2/8573/8712/868
Most frequent other events
Showing 10 of 21
Most frequent other events
EventDabigatran 220mgDabigatran 150mgEnoxaparin
Oedema peripheralGeneral disorders244/857275/871254/868
ConstipationGastrointestinal disorders229/857268/871245/868
NauseaGastrointestinal disorders198/857204/871189/868
PyrexiaGeneral disorders154/857157/871167/868
Post procedural painInjury, poisoning and procedural complications110/857114/87184/868
VomitingGastrointestinal disorders105/857110/87195/868
InsomniaPsychiatric disorders100/857105/871109/868
Deep vein thrombosisVascular disorders86/85793/87165/868
Urinary retentionRenal and urinary disorders72/85782/87160/868
DizzinessNervous system disorders56/85759/87179/868

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Dabigatran 220mgDabigatran 150mgEnoxaparinTotal
Mean66.2 ± 9.565.9 ± 9.566.3 ± 9.666.1 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)Dabigatran 220mgDabigatran 150mgEnoxaparinTotal
Female4865075041497
Male3713643641099
Body Mass Index
Body Mass Index(kg/m^2)Dabigatran 220mgDabigatran 150mgEnoxaparinTotal
Mean31.6 ± 6.031.4 ± 6.131.4 ± 6.031.5 ± 6.1
08

Study locations

94 sites
  • 1160.24.01074 Capstone Clinical Trials, Inc.
    Birmingham, Alabama, United States
  • 1160.24.01079 West AL Research, Inc
    Northport, Alabama, United States
  • 1160.24.01047 Tucson Orhtopaedic Institute
    Tucson, Arizona, United States
  • 1160.24.01025 Martin, Bowen, Hefley Knee and Sports
    Little Rock, Arkansas, United States
  • 1160.24.01053 OrthoArkansas, PA
    Little Rock, Arkansas, United States
  • 1160.24.01085 Martin, Bowen, Hefley Knee and Sports
    Little Rock, Arkansas, United States
  • 1160.24.01041 Core Orthopedic Medical Center
    Encinitas, California, United States
  • 1160.24.01034 Glendale Adventist Medical Center
    Glendale, California, United States
  • 1160.24.01005 Scripps Clinical Ctr for Orthopedic Rsrch & Educ
    La Jolla, California, United States
  • 1160.24.01077 Long Beach VA Healthcare system
    Long Beach, California, United States
  • 1160.24.01064 Orthopedic Specialty Institute
    Orange, California, United States
  • 1160.24.01031 Colorodo Orthopedic Consultants, PC
    Aurora, Colorado, United States
  • 1160.24.01027 Advanced Orthopedic and Sports Medicine Specialists, PC
    Denver, Colorado, United States
  • 1160.24.01023 Orthopedic Physicians of Colorado, PC
    Engelwood, Colorado, United States
  • 1160.24.01020 Bay Pines VA Medical Center
    Bay Pines, Florida, United States
  • 1160.24.01024 Pulmonary Associates of Brandon Clinical Research
    Brandon, Florida, United States
  • 1160.24.01030 Alliance Research, Inc.
    Clearwater, Florida, United States
  • 1160.24.01039 Florida Orthopedic Associates
    Deland, Florida, United States
  • 1160.24.01036 Orthopaedic Associates of South Broward, PA
    Hollywood, Florida, United States
  • 1160.24.01010 MIMA Century Research Associates
    Melbourne, Florida, United States
  • 1160.24.01062 Miami Institute for Joint Reconstruction
    Miami, Florida, United States
  • 1160.24.01040 Southern Clinical Research Consultants
    Orlando, 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
  • 1160.24.01017 Boehringer Ingelheim Investigational Site
    Pinellas Park, Florida, United States
  • 1160.24.01019 Boehringer Ingelheim Investigational Site
    Pinellas Park, Florida, United States
  • 1160.24.01029 Coastal Medical Research
    Port Orange, Florida, United States
  • 1160.24.01038 James A. Haley VA Hospital
    Tampa, Florida, United States
  • 1160.24.01063 Resurgens Orthopaedics
    Atlanta, Georgia, United States
  • 1160.24.01072 Resurgeons Orthopedics
    Atlanta, Georgia, 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
  • 1160.24.01008 Bluegrass Orthopedic/Musculoskeletal Research, LLC
    Lexington, Kentucky, United States
  • 1160.24.01070 Sinai Hospital of Baltimore
    Baltimore, Maryland, United States
  • 1160.24.01007 Ortho Associates
    Towson, Maryland, United States
  • 1160.24.01059 Rockhill Orthopaedics
    Kansas City, Missouri, United States
  • 1160.24.01042 Center for Joint Care
    Missoula, Montana, United States
  • 1160.24.01014 Charlotte Orthopedic Specialists
    Charlotte, North Carolina, United States
  • 1160.24.01035 Wellington Orthopedics and Sports Medicine
    Cincinnati, Ohio, United States
  • 1160.24.01006 VA Medical Center
    Oklahoma City, Oklahoma, United States
  • 1160.24.01044 Tulsa Bone and Joint Associates
    Tulsa, Oklahoma, United States
  • 1160.24.01002 The Orthopedic and Neurological Center of the Cascades
    Bend, Oregon, United States
  • 1160.24.01046 Boehringer Ingelheim Investigational Site
    Philadelphia, Pennsylvania, United States
  • 1160.24.01016
    Charleston, South Carolina, United States
  • 1160.24.01073 Coastal Orthopedic Associates, PA
    Conway, South Carolina, United States
  • 1160.24.01032 Seton Medical Center
    Austin, Texas, United States
  • 1160.24.01003 Texas Orthopedic Associates
    Dallas, Texas, United States
  • 1160.24.01090 VA Medical Center
    Dallas, Texas, United States
  • 1160.24.01026 James Muntz, MD
    Houston, Texas, United States
  • 1160.24.01033 Bone and Joint Clinic of Houston
    Houston, Texas, United States
  • 1160.24.01076 Discovery Alliance
    Houston, Texas, United States
  • 1160.24.01018 Gill Research Center
    Lubbock, Texas, United States
  • 1160.24.01069 Correspondence and Pateint vists
    Plano, Texas, United States
  • 1160.24.01015 Unlimited Research, LP
    San Antonio, Texas, United States
  • 1160.24.01012 Anderson Orthopedic Clinic
    Alexandria, Virginia, United States
  • 1160.24.01052 Swedish Medical Center
    Seattle, Washington, United States
  • 1160.24.01057 Orthopedic Specialty Clinic of Spokane, PLLC
    Spokane, Washington, United States
  • 1160.24.01082 MultiCare Health System
    Tacoma, Washington, United States
  • 1160.24.02031 University of Alberta Hospital
    Edmonton, Alberta, Canada
  • 1160.24.02036 2B2.37 Walter Mackenizie Centre
    Edmonton, Alberta, Canada
  • 1160.24.02024 Red Deer Regional Hospital
    Red Deer, Alberta, Canada
  • 1160.24.02032 Kelowna General Hospital
    Kelowna, British Columbia, Canada
  • 1160.24.02034 Hematology/Oncology Research
    Vancouver, British Columbia, Canada
  • 1160.24.02025 Grace General Hospital
    Winnipeg, Manitoba, Canada
  • 1160.24.02007 Orthopaedics 4NE
    Fredericton, New Brunswick, Canada
  • 1160.24.02027 Atlantic Health Sciences Corporation
    Saint John, New Brunswick, 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
  • 1160.24.02010 Joseph Brant Memorial Hospital
    Burlington, Ontario, Canada
  • 1160.24.02001 73 Delhi Street
    Guelph, Ontario, Canada
  • 1160.24.02014 565 Sanatorium Road
    Hamilton, Ontario, Canada
  • 1160.24.02004 Grand River Hospital
    Kitchener, Ontario, Canada
  • 1160.24.02028 NHS- Greater Niagara General Site
    Niagara Falls, Ontario, Canada
  • 1160.24.02022 Lakeridge Health Oshawa
    Oshawa, Ontario, Canada
  • 1160.24.02017 1053 Carling Avenue
    Ottawa, Ontario, Canada
  • 1160.24.02026 Ottawa Hospital - General Campus
    Ottawa, Ontario, Canada
  • 1160.24.02015 York Central Hospital Research
    Richmond Hill, Ontario, Canada
  • 1160.24.02009 2863 Ellesmere Road
    Scarborough, Ontario, Canada
  • 1160.24.02029 Niagara Health System St. Catharine's General Site
    St. Catherine's, Ontario, Canada
  • 1160.24.02003 46 General Hospital Drive
    Stratford, Ontario, Canada
  • 1160.24.02033 Thunder Bay Regional Hospital
    Thunder Bay, Ontario, 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
  • 1160.24.02006 206-477 King Street
    Welland, Ontario, Canada
  • 1160.24.02035 Humber River Regional Hospital
    Weston, Ontario, Canada
  • 1160.24.02011 Windsor Regional Hospital
    Windsor, Ontario, Canada
  • 1160.24.02012 Hotel Dieu Grace Hospital
    Windsor, Ontario, Canada
  • 1160.24.02013 Queen Elizabeth Hospital
    Charlottetown, Prince Edward Island, Canada
  • 1160.24.05009 Traumatologia, Planta Baja
    Guadalajara, Jalisco, Mexico
  • 1160.24.05004
    México, Mexico
  • 1160.24.44001 Ravenscourt Park Hospital
    London, United Kingdom
09

References and documents

Publications

  • 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. PubMed 22709460 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00152971
Lead sponsor
Boehringer Ingelheim
First posted
Sep 12, 2005
Start date
Nov 2004
Primary completion
Jun 2006
Results posted
Dec 17, 2010
Last update
May 5, 2014

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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