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Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

Primary Purpose

Thromboembolism, Arthroplasty, Replacement, Hip

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dabigatran etexilate
dabigatran etexilate
enoxaparin
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thromboembolism

Eligibility Criteria

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

Inclusion criteria Inclusion criteria (selected): Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement Written Informed Consent Exclusion criteria Exclusion criteria (selected): Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia. Active malignant disease or current cytostatic treatment Known severe renal insufficiency Liver disease expected to have any potential impact on survival, or elevated AST or ALT > 2x upper limit of normal Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practising or do not plan to continue practising acceptable methods of birth control Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced thrombocytopenia) or dabigatran Contraindications to enoxaparin Participation in a clinical trial during the last 30 days

Sites / Locations

  • 1160.48.06108 Canberra Hospital
  • 1160.48.06106 St George Public Hospital
  • 1160.48.06110 Suite 13 level 4
  • 1160.48.06105 Flinders Medical Centre
  • 1160.48.06104 Ecru
  • 1160.48.06102 Monash Medical Centre
  • 1160.48.06101 Emeritus Research
  • 1160.48.06103 Maroondah Hospital
  • 1160.48.06113
  • 1160.48.06111 Haemophillia & Thrombosis Service
  • 1160.48.04304 Boehringer Ingelheim Investigational Site
  • 1160.48.04303 Boehringer Ingelheim Investigational Site
  • 1160.48.04302 Boehringer Ingelheim Investigational Site
  • 1160.48.04301 Boehringer Ingelheim Investigational Site
  • 1160.48.03207 UVC Brugmann
  • 1160.48.03206 Campus Sint-Lucas
  • 1160.48.03208 UZ Gent
  • 1160.48.03202 Boehringer Ingelheim Investigational Site
  • 1160.48.03203 AZ Sint Elisabeth
  • 1160.48.03205 Ziekenhuis Oost-Limburg
  • 1160.48.03201 UZ Gasthuisberg
  • 1160.48.42004 Boehringer Ingelheim Investigational Site
  • 1160.48.42010 Boehringer Ingelheim Investigational Site
  • 1160.48.42009 Boehringer Ingelheim Investigational Site
  • 1160.48.42008 Boehringer Ingelheim Investigational Site
  • 1160.48.42002 Boehringer Ingelheim Investigational Site
  • 1160.48.42006 Boehringer Ingelheim Investigational Site
  • 1160.48.42003 Boehringer Ingelheim Investigational Site
  • 1160.48.42001 Boehringer Ingelheim Investigational Site
  • 1160.48.42007 Boehringer Ingelheim Investigational Site
  • 1160.48.42005 Boehringer Ingelheim Investigational Site
  • 1160.48.04571 Boehringer Ingelheim Investigational Site
  • 1160.48.04570 Boehringer Ingelheim Investigational Site
  • 1160.48.04573 Boehringer Ingelheim Investigational Site
  • 1160.48.04574 Boehringer Ingelheim Investigational Site
  • 1160.48.04575 Boehringer Ingelheim Investigational Site
  • 1160.48.35803 Boehringer Ingelheim Investigational Site
  • 1160.48.35802 Boehringer Ingelheim Investigational Site
  • 1160.48.35801 Boehringer Ingelheim Investigational Site
  • 1160.48.35804 Boehringer Ingelheim Investigational Site
  • 1160.48.35805 Boehringer Ingelheim Investigational Site
  • 1160.48.03304 Boehringer Ingelheim Investigational Site
  • 1160.48.03303 Boehringer Ingelheim Investigational Site
  • 1160.48.03302 Boehringer Ingelheim Investigational Site
  • 1160.48.03308 Boehringer Ingelheim Investigational Site
  • 1160.48.04906 Caritaskrankenhaus
  • 1160.48.04910 F.-A.-Universität Erlangen-Nürnberg
  • 1160.48.04904 Orthopädische Universitätsklinik
  • 1160.48.04902 Klinikum Garmisch-Partenkirchen
  • 1160.48.04914 St. Bernhard-Hospital
  • 1160.48.04907 Johannes Gutenberg-Universität Mainz
  • 1160.48.04912 Orthopädische Klinik Markgröningen gGmbH
  • 1160.48.04901 Kreiskrankenhaus
  • 1160.48.04915 Orthopädische Klinik Lindenlohe
  • 1160.48.04903 Hellmuth-Ulrici-Kliniken
  • 1160.48.04905 Aukammklinik
  • 1160.48.03603 Boehringer Ingelheim Investigational Site
  • 1160.48.03606 Boehringer Ingelheim Investigational Site
  • 1160.48.03607 Boehringer Ingelheim Investigational Site
  • 1160.48.03601 Boehringer Ingelheim Investigational Site
  • 1160.48.03604 Boehringer Ingelheim Investigational Site
  • 1160.48.03602 Boehringer Ingelheim Investigational Site
  • 1160.48.03605 Boehringer Ingelheim Investigational Site
  • 1160.48.03903 Boehringer Ingelheim Investigational Site
  • 1160.48.03904 Boehringer Ingelheim Investigational Site
  • 1160.48.03902 Boehringer Ingelheim Investigational Site
  • 1160.48.03901 Boehringer Ingelheim Investigational Site
  • 1160.48.03102 Boehringer Ingelheim Investigational Site
  • 1160.48.03101 Boehringer Ingelheim Investigational Site
  • 1160.48.03107 Boehringer Ingelheim Investigational Site
  • 1160.48.03103 Boehringer Ingelheim Investigational Site
  • 1160.48.03104 Boehringer Ingelheim Investigational Site
  • 1160.48.03105 Boehringer Ingelheim Investigational Site
  • 1160.48.04701 Boehringer Ingelheim Investigational Site
  • 1160.48.04704 Boehringer Ingelheim Investigational Site
  • 1160.48.04707 Boehringer Ingelheim Investigational Site
  • 1160.48.04706 Boehringer Ingelheim Investigational Site
  • 1160.48.04702 Boehringer Ingelheim Investigational Site
  • 1160.48.04703 Boehringer Ingelheim Investigational Site
  • 1160.48.04810 Boehringer Ingelheim Investigational Site
  • 1160.48.04804 Boehringer Ingelheim Investigational Site
  • 1160.48.04806 Boehringer Ingelheim Investigational Site
  • 1160.48.04807 Boehringer Ingelheim Investigational Site
  • 1160.48.04812 Boehringer Ingelheim Investigational Site
  • 1160.48.04820 Boehringer Ingelheim Investigational Site
  • 1160.48.04814 Boehringer Ingelheim Investigational Site
  • 1160.48.04808 Boehringer Ingelheim Investigational Site
  • 1160.48.04817 Boehringer Ingelheim Investigational Site
  • 1160.48.04801 Boehringer Ingelheim Investigational Site
  • 1160.48.04802 Boehringer Ingelheim Investigational Site
  • 1160.48.04803 Boehringer Ingelheim Investigational Site
  • 1160.48.02701 Boehringer Ingelheim Investigational Site
  • 1160.48.02704 Boehringer Ingelheim Investigational Site
  • 1160.48.02703 Boehringer Ingelheim Investigational Site
  • 1160.48.02702 Boehringer Ingelheim Investigational Site
  • 1160.48.03405 Boehringer Ingelheim Investigational Site
  • 1160.48.03403 Boehringer Ingelheim Investigational Site
  • 1160.48.03411 Boehringer Ingelheim Investigational Site
  • 1160.48.03407 Boehringer Ingelheim Investigational Site
  • 1160.48.03409 Boehringer Ingelheim Investigational Site
  • 1160.48.03401 Boehringer Ingelheim Investigational Site
  • 1160.48.03402 Boehringer Ingelheim Investigational Site
  • 1160.48.03404 Boehringer Ingelheim Investigational Site
  • 1160.48.03406 Boehringer Ingelheim Investigational Site
  • 1160.48.03408 Boehringer Ingelheim Investigational Site
  • 1160.48.03410 Boehringer Ingelheim Investigational Site
  • 1160.48.04602 Boehringer Ingelheim Investigational Site
  • 1160.48.04601 Boehringer Ingelheim Investigational Site
  • 1160.48.04607 Boehringer Ingelheim Investigational Site
  • 1160.48.04606 Boehringer Ingelheim Investigational Site
  • 1160.48.04603 Boehringer Ingelheim Investigational Site
  • 1160.48.04608 Boehringer Ingelheim Investigational Site
  • 1160.48.04605 Boehringer Ingelheim Investigational Site
  • 1160.48.04604 Boehringer Ingelheim Investigational Site
  • 1160.48.04610 Boehringer Ingelheim Investigational Site
  • 1160.48.04609 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

dabigatran etexilate 75 mg

dabigatran etexilate 110 mg

enoxaparin

Arm Description

daily dose 150 mg once daily, half a dose on the day of surgery

daily dose 220 mg once daily, half a dose on the day of surgery

40 mg once daily

Outcomes

Primary Outcome Measures

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

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
Proximal Deep Vein Thrombosis During Treatment Period
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Total Deep Vein Thrombosis During Treatment Period
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
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
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
Death During Treatment Period
All cause death, as adjudicated by the VTE events committee
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.
Blood Transfusion
Blood transfusion for treated and operated patients on Day of surgery.
Volume of Blood Loss
Volume of blood loss for treated and operated patients during surgery.
Laboratory Analyses
Frequency of patients with possible clinically significant abnormalities.

Full Information

First Posted
September 12, 2005
Last Updated
May 8, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00168818
Brief Title
Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery
Official Title
A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
3494 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dabigatran etexilate 75 mg
Arm Type
Experimental
Arm Description
daily dose 150 mg once daily, half a dose on the day of surgery
Arm Title
dabigatran etexilate 110 mg
Arm Type
Experimental
Arm Description
daily dose 220 mg once daily, half a dose on the day of surgery
Arm Title
enoxaparin
Arm Type
Active Comparator
Arm Description
40 mg once daily
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate
Intervention Description
daily dose 150 mg once daily, half a dose on the day of surgery
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate
Intervention Description
daily dose 150 mg once daily, half a dose on the day of surgery
Intervention Type
Drug
Intervention Name(s)
enoxaparin
Intervention Description
40 mg once daily
Primary Outcome Measure Information:
Title
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 31-38 days
Secondary Outcome Measure Information:
Title
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 31-38 days
Title
Proximal Deep Vein Thrombosis During Treatment Period
Description
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Time Frame
First administration until 31-38 days
Title
Total Deep Vein Thrombosis During Treatment Period
Description
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Time Frame
First administration until 31-38 days
Title
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 31-38 days
Title
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 31-38 days
Title
Death During Treatment Period
Description
All cause death, as adjudicated by the VTE events committee
Time Frame
First administration until 31-38 days
Title
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
end of treatment to day 91±7
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 31-38 days
Title
Blood Transfusion
Description
Blood transfusion for treated and operated patients on Day of surgery.
Time Frame
Day 1
Title
Volume of Blood Loss
Description
Volume of blood loss for treated and operated patients during surgery.
Time Frame
Day 1
Title
Laboratory Analyses
Description
Frequency of patients with possible clinically significant abnormalities.
Time Frame
First administration to end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Inclusion criteria (selected): Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement Written Informed Consent Exclusion criteria Exclusion criteria (selected): Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia. Active malignant disease or current cytostatic treatment Known severe renal insufficiency Liver disease expected to have any potential impact on survival, or elevated AST or ALT > 2x upper limit of normal Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practising or do not plan to continue practising acceptable methods of birth control Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced thrombocytopenia) or dabigatran Contraindications to enoxaparin Participation in a clinical trial during the last 30 days
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
1160.48.06108 Canberra Hospital
City
Garren
State/Province
Australian Capital Territory
Country
Australia
Facility Name
1160.48.06106 St George Public Hospital
City
Kogarah
State/Province
New South Wales
Country
Australia
Facility Name
1160.48.06110 Suite 13 level 4
City
Lismore
State/Province
New South Wales
Country
Australia
Facility Name
1160.48.06105 Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
Country
Australia
Facility Name
1160.48.06104 Ecru
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
1160.48.06102 Monash Medical Centre
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
1160.48.06101 Emeritus Research
City
Malvern
State/Province
Victoria
Country
Australia
Facility Name
1160.48.06103 Maroondah Hospital
City
Ringwood East
State/Province
Victoria
Country
Australia
Facility Name
1160.48.06113
City
Windsor
State/Province
Victoria
Country
Australia
Facility Name
1160.48.06111 Haemophillia & Thrombosis Service
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
1160.48.04304 Boehringer Ingelheim Investigational Site
City
Linz
Country
Austria
Facility Name
1160.48.04303 Boehringer Ingelheim Investigational Site
City
Wels
Country
Austria
Facility Name
1160.48.04302 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1160.48.04301 Boehringer Ingelheim Investigational Site
City
Wr. Neustadt
Country
Austria
Facility Name
1160.48.03207 UVC Brugmann
City
Brussels
Country
Belgium
Facility Name
1160.48.03206 Campus Sint-Lucas
City
Gent
Country
Belgium
Facility Name
1160.48.03208 UZ Gent
City
Gent
Country
Belgium
Facility Name
1160.48.03202 Boehringer Ingelheim Investigational Site
City
Hasselt
Country
Belgium
Facility Name
1160.48.03203 AZ Sint Elisabeth
City
Herentals
Country
Belgium
Facility Name
1160.48.03205 Ziekenhuis Oost-Limburg
City
Lanaken
Country
Belgium
Facility Name
1160.48.03201 UZ Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
1160.48.42004 Boehringer Ingelheim Investigational Site
City
Brno-Bohunice
Country
Czech Republic
Facility Name
1160.48.42010 Boehringer Ingelheim Investigational Site
City
Chomutov
Country
Czech Republic
Facility Name
1160.48.42009 Boehringer Ingelheim Investigational Site
City
Havlickuv Brod
Country
Czech Republic
Facility Name
1160.48.42008 Boehringer Ingelheim Investigational Site
City
Jihlava
Country
Czech Republic
Facility Name
1160.48.42002 Boehringer Ingelheim Investigational Site
City
Kladno
Country
Czech Republic
Facility Name
1160.48.42006 Boehringer Ingelheim Investigational Site
City
Kolin
Country
Czech Republic
Facility Name
1160.48.42003 Boehringer Ingelheim Investigational Site
City
Ostrava
Country
Czech Republic
Facility Name
1160.48.42001 Boehringer Ingelheim Investigational Site
City
Plzen
Country
Czech Republic
Facility Name
1160.48.42007 Boehringer Ingelheim Investigational Site
City
Pradubice
Country
Czech Republic
Facility Name
1160.48.42005 Boehringer Ingelheim Investigational Site
City
Prague 8
Country
Czech Republic
Facility Name
1160.48.04571 Boehringer Ingelheim Investigational Site
City
Hellerup
Country
Denmark
Facility Name
1160.48.04570 Boehringer Ingelheim Investigational Site
City
Hørsholm
Country
Denmark
Facility Name
1160.48.04573 Boehringer Ingelheim Investigational Site
City
København NV
Country
Denmark
Facility Name
1160.48.04574 Boehringer Ingelheim Investigational Site
City
København S
Country
Denmark
Facility Name
1160.48.04575 Boehringer Ingelheim Investigational Site
City
Silkeborg
Country
Denmark
Facility Name
1160.48.35803 Boehringer Ingelheim Investigational Site
City
Helsinki
Country
Finland
Facility Name
1160.48.35802 Boehringer Ingelheim Investigational Site
City
Jyväskylä
Country
Finland
Facility Name
1160.48.35801 Boehringer Ingelheim Investigational Site
City
Oulu
Country
Finland
Facility Name
1160.48.35804 Boehringer Ingelheim Investigational Site
City
Seinäjoki
Country
Finland
Facility Name
1160.48.35805 Boehringer Ingelheim Investigational Site
City
Tampere
Country
Finland
Facility Name
1160.48.03304 Boehringer Ingelheim Investigational Site
City
Amiens cedex 1
Country
France
Facility Name
1160.48.03303 Boehringer Ingelheim Investigational Site
City
Roubaix cedex
Country
France
Facility Name
1160.48.03302 Boehringer Ingelheim Investigational Site
City
Soyaux
Country
France
Facility Name
1160.48.03308 Boehringer Ingelheim Investigational Site
City
Strasbourg
Country
France
Facility Name
1160.48.04906 Caritaskrankenhaus
City
Bad Mergentheim
Country
Germany
Facility Name
1160.48.04910 F.-A.-Universität Erlangen-Nürnberg
City
Erlangen
Country
Germany
Facility Name
1160.48.04904 Orthopädische Universitätsklinik
City
Frankfurt
Country
Germany
Facility Name
1160.48.04902 Klinikum Garmisch-Partenkirchen
City
Garmisch-Partenkirchen
Country
Germany
Facility Name
1160.48.04914 St. Bernhard-Hospital
City
Kamp-Lintfort
Country
Germany
Facility Name
1160.48.04907 Johannes Gutenberg-Universität Mainz
City
Mainz
Country
Germany
Facility Name
1160.48.04912 Orthopädische Klinik Markgröningen gGmbH
City
Markgröningen
Country
Germany
Facility Name
1160.48.04901 Kreiskrankenhaus
City
Rheinfelden
Country
Germany
Facility Name
1160.48.04915 Orthopädische Klinik Lindenlohe
City
Schwandorf
Country
Germany
Facility Name
1160.48.04903 Hellmuth-Ulrici-Kliniken
City
Sommerfeld
Country
Germany
Facility Name
1160.48.04905 Aukammklinik
City
Wiesbaden
Country
Germany
Facility Name
1160.48.03603 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1160.48.03606 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1160.48.03607 Boehringer Ingelheim Investigational Site
City
Békéscsaba
Country
Hungary
Facility Name
1160.48.03601 Boehringer Ingelheim Investigational Site
City
Gyula
Country
Hungary
Facility Name
1160.48.03604 Boehringer Ingelheim Investigational Site
City
Kecskemét
Country
Hungary
Facility Name
1160.48.03602 Boehringer Ingelheim Investigational Site
City
Szeged
Country
Hungary
Facility Name
1160.48.03605 Boehringer Ingelheim Investigational Site
City
Székesfehérvár
Country
Hungary
Facility Name
1160.48.03903 Boehringer Ingelheim Investigational Site
City
Bergamo
Country
Italy
Facility Name
1160.48.03904 Boehringer Ingelheim Investigational Site
City
Bologna
Country
Italy
Facility Name
1160.48.03902 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1160.48.03901 Boehringer Ingelheim Investigational Site
City
Pavia
Country
Italy
Facility Name
1160.48.03102 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1160.48.03101 Boehringer Ingelheim Investigational Site
City
Heemstede
Country
Netherlands
Facility Name
1160.48.03107 Boehringer Ingelheim Investigational Site
City
Helmond
Country
Netherlands
Facility Name
1160.48.03103 Boehringer Ingelheim Investigational Site
City
Hilversum
Country
Netherlands
Facility Name
1160.48.03104 Boehringer Ingelheim Investigational Site
City
Nijmegen
Country
Netherlands
Facility Name
1160.48.03105 Boehringer Ingelheim Investigational Site
City
Sittard
Country
Netherlands
Facility Name
1160.48.04701 Boehringer Ingelheim Investigational Site
City
Bodø
Country
Norway
Facility Name
1160.48.04704 Boehringer Ingelheim Investigational Site
City
Bærum Postterminal
Country
Norway
Facility Name
1160.48.04707 Boehringer Ingelheim Investigational Site
City
Bærum Postterminal
Country
Norway
Facility Name
1160.48.04706 Boehringer Ingelheim Investigational Site
City
Elverum
Country
Norway
Facility Name
1160.48.04702 Boehringer Ingelheim Investigational Site
City
Skien
Country
Norway
Facility Name
1160.48.04703 Boehringer Ingelheim Investigational Site
City
Ålesund
Country
Norway
Facility Name
1160.48.04810 Boehringer Ingelheim Investigational Site
City
Bialystok
Country
Poland
Facility Name
1160.48.04804 Boehringer Ingelheim Investigational Site
City
Kielce
Country
Poland
Facility Name
1160.48.04806 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
1160.48.04807 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
1160.48.04812 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
1160.48.04820 Boehringer Ingelheim Investigational Site
City
Lodz
Country
Poland
Facility Name
1160.48.04814 Boehringer Ingelheim Investigational Site
City
Mielec
Country
Poland
Facility Name
1160.48.04808 Boehringer Ingelheim Investigational Site
City
Piekary Slaskie
Country
Poland
Facility Name
1160.48.04817 Boehringer Ingelheim Investigational Site
City
Rzeszow
Country
Poland
Facility Name
1160.48.04801 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.48.04802 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.48.04803 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.48.02701 Boehringer Ingelheim Investigational Site
City
Bryanston
Country
South Africa
Facility Name
1160.48.02704 Boehringer Ingelheim Investigational Site
City
Johannesburg
Country
South Africa
Facility Name
1160.48.02703 Boehringer Ingelheim Investigational Site
City
Randburg
Country
South Africa
Facility Name
1160.48.02702 Boehringer Ingelheim Investigational Site
City
Sandton
Country
South Africa
Facility Name
1160.48.03405 Boehringer Ingelheim Investigational Site
City
Alcorcón (Madrid)
Country
Spain
Facility Name
1160.48.03403 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1160.48.03411 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1160.48.03407 Boehringer Ingelheim Investigational Site
City
Hospitalet (Barcelona)
Country
Spain
Facility Name
1160.48.03409 Boehringer Ingelheim Investigational Site
City
Jaén
Country
Spain
Facility Name
1160.48.03401 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1160.48.03402 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1160.48.03404 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1160.48.03406 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1160.48.03408 Boehringer Ingelheim Investigational Site
City
Móstoles (Madrid)
Country
Spain
Facility Name
1160.48.03410 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1160.48.04602 Boehringer Ingelheim Investigational Site
City
Falköping
Country
Sweden
Facility Name
1160.48.04601 Boehringer Ingelheim Investigational Site
City
Göteborg
Country
Sweden
Facility Name
1160.48.04607 Boehringer Ingelheim Investigational Site
City
Halmstad
Country
Sweden
Facility Name
1160.48.04606 Boehringer Ingelheim Investigational Site
City
Kalmar
Country
Sweden
Facility Name
1160.48.04603 Boehringer Ingelheim Investigational Site
City
Kungälv
Country
Sweden
Facility Name
1160.48.04608 Boehringer Ingelheim Investigational Site
City
Lidköping
Country
Sweden
Facility Name
1160.48.04605 Boehringer Ingelheim Investigational Site
City
Linköping
Country
Sweden
Facility Name
1160.48.04604 Boehringer Ingelheim Investigational Site
City
Mölndal
Country
Sweden
Facility Name
1160.48.04610 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1160.48.04609 Boehringer Ingelheim Investigational Site
City
Varberg
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26578849
Citation
Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Feuring M, Kreuzer J, Huo M, Friedman RJ. Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials. Thromb J. 2015 Nov 17;13:36. doi: 10.1186/s12959-015-0067-8. eCollection 2015.
Results Reference
derived
PubMed Identifier
22995531
Citation
Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Kurth AA. Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis. Thromb Res. 2012 Dec;130(6):871-6. doi: 10.1016/j.thromres.2012.08.315. Epub 2012 Sep 17.
Results Reference
derived
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
PubMed Identifier
17869635
Citation
Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, Buller HR; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007 Sep 15;370(9591):949-56. doi: 10.1016/S0140-6736(07)61445-7. Erratum In: Lancet. 2007 Dec 15;370(9604):2004.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.48_U06-1618-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.48_literature.pdf
Description
Related Info

Learn more about this trial

Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

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