An open label, non-comparative, pharmacokinetic and pharmacodynamic study to evaluate the effect of Dabigatran Etexilate on coagulation parameters including a calibrated thrombin time test in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing primary unilateral elective total knee or hip replacement surgery
Phase 4
Completed
- Conditions
- prevention of venous thromboembolism1000594410014523
- Registration Number
- NL-OMON34322
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1) patients scheduled for primary unilateral elective total knee or hip replacement, male or
female being 18 years or older
2) moderate renal impairment (creatine clearance 30 - 50 ml/min)
3) written informed consent
4) caucasian patients
Exclusion Criteria
1) Patients weighing less than 40 kg
2) patients requiring chronic treatment with anticoagulants
3) patients who in the investigators judgement are perceived as having an excessive risk of
bleeding
4) recent unstable cardiovasculair disease
5) ongoing treatment for VTE;See page 19 - 21 of the study protocol for all exclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacodynamic parameters:<br /><br>- clotting time and calculated dabigatran plasma concentration<br /><br>- aPTT<br /><br>- ECT<br /><br><br /><br>Pharmacokinetic parameters:<br /><br>- total dabigatran plasma concentrations in serial samples<br /><br>- Cmax, AUC on day 6 (+/-1) and Cmin</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety:<br /><br>- adverse events </p><br>