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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00168818
Registration number
NCT00168818
Ethics application status
Date submitted
12/09/2005
Date registered
15/09/2005
Date last updated
19/05/2014
Titles & IDs
Public title
Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery
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Scientific 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)
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Secondary ID [1]
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2004-001988-21
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Secondary ID [2]
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1160.48
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Thromboembolism
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Arthroplasty, Replacement, Hip
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - dabigatran etexilate
Treatment: Drugs - dabigatran etexilate
Treatment: Drugs - enoxaparin
Experimental: dabigatran etexilate 75 mg - daily dose 150 mg once daily, half a dose on the day of surgery
Experimental: dabigatran etexilate 110 mg - daily dose 220 mg once daily, half a dose on the day of surgery
Active comparator: enoxaparin - 40 mg once daily
Treatment: Drugs: dabigatran etexilate
daily dose 150 mg once daily, half a dose on the day of surgery
Treatment: Drugs: dabigatran etexilate
daily dose 150 mg once daily, half a dose on the day of surgery
Treatment: Drugs: enoxaparin
40 mg once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
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Assessment method [1]
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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.
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Timepoint [1]
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First administration until 31-38 days
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Secondary outcome [1]
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Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
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Assessment method [1]
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Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
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Timepoint [1]
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First administration until 31-38 days
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Secondary outcome [2]
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Proximal Deep Vein Thrombosis During Treatment Period
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Assessment method [2]
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Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
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Timepoint [2]
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First administration until 31-38 days
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Secondary outcome [3]
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Total Deep Vein Thrombosis During Treatment Period
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Assessment method [3]
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Total Deep Vein Thrombosis as adjudicated by the VTE events committee
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Timepoint [3]
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First administration until 31-38 days
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Secondary outcome [4]
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Symptomatic Deep Vein Thrombosis During Treatment Period
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Assessment method [4]
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Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
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Timepoint [4]
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First administration until 31-38 days
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Secondary outcome [5]
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Pulmonary Embolism During Treatment Period
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Assessment method [5]
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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
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Timepoint [5]
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First administration until 31-38 days
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Secondary outcome [6]
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Death During Treatment Period
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Assessment method [6]
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All cause death, as adjudicated by the VTE events committee
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Timepoint [6]
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First administration until 31-38 days
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Secondary outcome [7]
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Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
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Assessment method [7]
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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).
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Timepoint [7]
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end of treatment to day 91±7
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Secondary outcome [8]
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Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
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Assessment method [8]
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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.
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Timepoint [8]
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First administration until 31-38 days
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Secondary outcome [9]
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Blood Transfusion
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Assessment method [9]
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Blood transfusion for treated and operated patients on Day of surgery.
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Timepoint [9]
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Day 1
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Secondary outcome [10]
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Volume of Blood Loss
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Assessment method [10]
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Volume of blood loss for treated and operated patients during surgery.
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Timepoint [10]
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Day 1
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Secondary outcome [11]
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Laboratory Analyses
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Assessment method [11]
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Frequency of patients with possible clinically significant abnormalities.
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Timepoint [11]
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First administration to end of study
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Eligibility
Key inclusion criteria
Inclusion criteria
Inclusion criteria (selected):
* Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement
* Written Informed Consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
3494
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
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Recruitment hospital [1]
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1160.48.06108 Canberra Hospital - Garren
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Recruitment hospital [2]
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1160.48.06106 St George Public Hospital - Kogarah
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Recruitment hospital [3]
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1160.48.06110 Suite 13 level 4 - Lismore
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Recruitment hospital [4]
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1160.48.06105 Flinders Medical Centre - Bedford Park
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Recruitment hospital [5]
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1160.48.06104 Ecru - Box Hill
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Recruitment hospital [6]
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1160.48.06102 Monash Medical Centre - Clayton
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Recruitment hospital [7]
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1160.48.06101 Emeritus Research - Malvern
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Recruitment hospital [8]
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1160.48.06103 Maroondah Hospital - Ringwood East
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Recruitment hospital [9]
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1160.48.06113 - Windsor
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Recruitment hospital [10]
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1160.48.06111 Haemophillia & Thrombosis Service - Perth
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Recruitment postcode(s) [1]
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- Garren
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Recruitment postcode(s) [2]
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- Kogarah
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Recruitment postcode(s) [3]
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- Lismore
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Recruitment postcode(s) [4]
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- Bedford Park
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Recruitment postcode(s) [5]
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- Box Hill
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Recruitment postcode(s) [6]
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- Clayton
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Recruitment postcode(s) [7]
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- Malvern
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Recruitment postcode(s) [8]
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- Ringwood East
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Recruitment postcode(s) [9]
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- Windsor
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Recruitment postcode(s) [10]
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- Perth
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Linz
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Austria
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Wels
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Austria
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Wien
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Austria
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State/province [4]
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Wr. Neustadt
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Herentals
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Lanaken
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Leuven
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Brno-Bohunice
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Chomutov
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Havlickuv Brod
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Jihlava
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Kladno
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Kolin
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Ostrava
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Czech Republic
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Plzen
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Pradubice
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Prague 8
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Hellerup
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Oulu
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Finland
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Seinäjoki
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Tampere
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France
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Amiens cedex 1
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France
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France
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Bad Mergentheim
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Erlangen
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Frankfurt
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Garmisch-Partenkirchen
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Kamp-Lintfort
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Germany
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Mainz
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Germany
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Markgröningen
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Germany
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Rheinfelden
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Germany
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Schwandorf
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Wiesbaden
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Békéscsaba
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Hungary
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Gyula
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Hungary
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Kecskemét
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Hungary
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Szeged
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Hungary
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Székesfehérvár
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Milano
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Italy
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Pavia
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Netherlands
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Amsterdam
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Heemstede
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Helmond
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Hilversum
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Netherlands
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Nijmegen
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Netherlands
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Sittard
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Norway
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Bodø
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Norway
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Bærum Postterminal
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Norway
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Elverum
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Norway
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Skien
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Norway
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Ålesund
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Poland
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Bialystok
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Kielce
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Krakow
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Lodz
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Mielec
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Piekary Slaskie
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Rzeszow
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Warsaw
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South Africa
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Bryanston
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South Africa
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Johannesburg
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South Africa
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Randburg
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South Africa
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Sandton
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Spain
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Alcorcón (Madrid)
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Spain
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Barcelona
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Spain
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Hospitalet (Barcelona)
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Spain
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Jaén
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Spain
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Madrid
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Spain
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Móstoles (Madrid)
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Spain
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Valencia
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Sweden
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Falköping
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Göteborg
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Halmstad
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Sweden
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Kalmar
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Sweden
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Kungälv
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Sweden
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Lidköping
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Sweden
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Linköping
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Sweden
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Mölndal
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Sweden
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Stockholm
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Sweden
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State/province [95]
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Varberg
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00168818
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Trial related presentations / publications
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. 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. 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. 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.
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Results are available at
https://clinicaltrials.gov/study/NCT00168818
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