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

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 - BI trial no.: 1160.86

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34322

Enrollment

Registered

2010-06-04

Start date

2010-06-30

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prevention of venous thromboembolism

Interventions

All patients will receive 150 mg dabigatran etexilate (Pradaxa) taken once daily as 2 capsules of 75 mg, at the day of surgery the treatment will be initiated 1-4 hours post surgery with half a dose

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Pharmacodynamic parameters: - clotting time and calculated dabigatran plasma concentration - aPTT - ECT Pharmacokinetic parameters: - total dabigatran plasma concentrations in serial samples - Cmax, AUC on day 6 (+/-1) and Cmin	—

Secondary

Measure	Time frame
Safety: - adverse events	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)