Prevention of venous thromboembolism following primary elective total hip replacement surgery
Conditions
Sponsors
Boehringer Ingelheim Finland Ky
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients scheduled to undergo a primary, unilateral elective total hip replacement 2. Male or female being 18 years or older 3. Patients weighing at least 40 kg 4. Written informed consent for study participation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of bleeding diathesis 2. Constitutional or acquired coagulation disorders that in the investigator’s judgement 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 enrolment (investigator’s judgement) or history of myocardial infarction within the last 3 months 5. Spinal or epidural anaesthesia, for which more than 3 attempts at placement were made (sticks), or the placement was traumatic 6. Any history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm 7. History of VTE still requiring specific treatment 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 year 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 enrolment 12. Known severe renal insufficiency (CrCl 160 mg/day or NSAID with t½ > 12 hours within 7 days prior to hip replacement surgery or anticipated need during the study treatment period (COX-2 selective inihibitors are allowed) 15. Anticipated required use of intermittent pneumatic compression and electric stimulation of lower limb 16. Pre-menopausal women (last menstruation ?1 year prior to signing informed consent) who: are pregnant, nursing or are of child-bearing potential and are NOT practising acceptable methods of birth control, or do NOT plan to continue practising an acceptable method throughout the study 17. Known allergy to radio opaque contrast media 18. History of thrombocytopenia (incl. heparin induced thrombocytopenia) or a platelet count < 100,000 cells/microliter at visit 1 19. Allergy to heparins or dabigatran 20. Active malignant disease or current cytostatic treatment 21. Participation in a clinical trial during the last 30 days 22. Leg amputee 23. Known alcohol or drug abuse which would interfere with completion of the study 24. Contraindications to enoxaparin 25. Previous participation in this study or RE-MODEL or RE-MOBILIZE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the comparative efficacy 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.;Secondary Objective: To determine the comparative 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.;Primary end point(s): Composite of total venous thromboembolic events (VTE) and all-cause mortality during the treatment period. Total VTE includes deep vein thrombosis [DVT] (proximal and distal) as detected by routine venography performed within 24 hours of the last dose of oral study medication; symptomatic DVT, confirmed by venous duplex ultrasound, venography or by autopsy; and pulmonary embolism confirmed by pulmonary ventilation-perfusion (V-Q) scintigraphy and chest X-ray or pulmonary angiography or spiral CT. | — |
Countries
Austria, Czech Republic, Denmark, Finland, Germany, Hungary, Italy, Spain, Sweden
Outcome results
None listed