Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate

Phase 4

Completed

• Conditions: Arthroplasty, Replacement; Prevention of Venous Thromboembolism; Moderate Renal Impairment (CrCl 30-50 mL/Min)
• Interventions: Drug: Dabigatran etexilate

• Registration Number: NCT01184989
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on coagulation parameters, including a calibrated thrombin time test, in patients with moderate renal impairment undergoing elective total hip- or knee-replacement surgery, this PK/PD study will be conducted.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-03-03
• Results First Submitted QC: 2014-04-25
• Results First Posted: 2014-05-23
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dabigatran etexilate	Dabigatran etexilate	open label, once daily dose approved by EMEA and Health Canada

Primary Outcome Measures

Name	Time	Method
Dabigatran Concentration in Plasma, Measured With HPLC-MS/MS	At day 6 before drug intake (di), at 1h, 2h, 4h, 8h and 24h after di	Dabigatran Concentration in Plasma, measured with HPLC-MS/MS - Most relevant timepoints are reported here, ie timepoints of day 6
Dabigatran Concentration in Plasma, Estimated From Local Hemoclot®	Screening, day of surgery 1 hour (h) and 2h after drug intake (di) for late finalization of surgery, 4h and 8h after di for early finalization of surgery, 15 minutes (min) before di at days 2, 3, 4, 5 and 6, at day 6 also 1h, 2h, 4h, 8h and 24 after di	The Hemoclot® test kit measures the dTT (diluted Thrombin time). In the present trial, as a first step, the dTT in calibration samples that had known Dabigatran concentrations was measured locally with the Hemoclot® test kit, and a linear calibration curve was fitted to the data from the calibration samples. Thereafter, for each patient at each time-point, the dTT was measured with the Hemoclot® kit and the Dabigatran concentration was read off from the calibration curve.; These estimated concentrations are compared with concentrations measured in parallel with HPLC-MS/MS.; As the trial objective is the method comparison and not the detection of the absolute concentrations of either of the methods, the result is reported as a relative bioavailability \[%\], see "Statistical Analysis 1" below. Only concentrations \>= LLOQ (Lower Limit of concentration) are included in the quantitative comparison.
Dabigatran Concentration in Plasma, Estimated From Central Hemoclot®	Screening, day of surgery 1 hour (h) and 2h after drug intake (di) for late finalization of surgery, 4h and 8h after di for early finalization of surgery, 15 minutes (min) before di at days 2, 3, 4, 5 and 6, at day 6 also 1h, 2h, 4h, 8h and 24 after di	The Hemoclot® test kit measures the dTT (diluted Thrombin time). In the present trial, as a first step, the dTT in calibration samples that had known Dabigatran concentrations was measured centrally with the Hemoclot® test kit, and a linear calibration curve was fitted to the data from the calibration samples. Thereafter, for each patient at each time-point, the dTT was measured with the Hemoclot® kit and the Dabigatran concentration was read off from the calibration curve.; These estimated concentrations are compared with concentrations measured in parallel with HPLC-MS/MS.; As the trial objective is the method comparison and not the detection of the absolute concentrations of either of the methods, the result is reported as a relative bioavailability \[%\], see "Statistical Analysis 1" below. Only concentrations \>= LLOQ (Lower Limit of concentration) are included in the quantitative comparison.

Trial Locations

Locations (10)

1160.86.35801 Boehringer Ingelheim Investigational Site; 🇫🇮 Jyväskylä, Finland

1160.86.01001 Boehringer Ingelheim Investigational Site; 🇨🇦 Red Deer, Alberta, Canada

1160.86.01002 Boehringer Ingelheim Investigational Site; 🇨🇦 Halifax, Nova Scotia, Canada

1160.86.31002 Boehringer Ingelheim Investigational Site; 🇳🇱 Hilversum, Netherlands

1160.86.01003 Boehringer Ingelheim Investigational Site; 🇨🇦 Charlottetown, Prince Edward Island, Canada

1160.86.43001 Boehringer Ingelheim Investigational Site; 🇦🇹 Graz, Austria

1160.86.43003 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1160.86.46001 Boehringer Ingelheim Investigational Site; 🇸🇪 Mölndal, Sweden

1160.86.42002 Boehringer Ingelheim Investigational Site; 🇨🇿 Prague 5, Czechia

1160.86.46002 Boehringer Ingelheim Investigational Site; 🇸🇪 Hässleholm, Sweden