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Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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

NCT01184989•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 (CrCl 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 (e.g. vitamin K antagonists; e.g. patients with atrial fibrillation, patients with artificial heart valves, etc.).
•3. Patients who in the investigator's judgment were perceived as having an excessive risk of bleeding, for example:
•Constitutional or acquired coagulation disorders
•History of bleeding diathesis
•Clinically relevant bleeding (gastrointestinal, pulmonary, intraocular or urogenital bleeding) within 3 months of enrolment
•Major surgery or trauma (e.g. hip fracture) within 3 months of enrolment
•History of thrombocytopenia, including heparin-induced thrombocytopenia, or a platelet count \<100 000 cells/microliter at randomization
•Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm
•Any arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
+17 more criteria

Locations (10)

1160.86.43001 Boehringer Ingelheim Investigational Site

Graz, Austria

1160.86.43003 Boehringer Ingelheim Investigational Site

Vienna, Austria

1160.86.01001 Boehringer Ingelheim Investigational Site

Red Deer, Alberta, Canada

1160.86.01002 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

1160.86.01003 Boehringer Ingelheim Investigational Site

Charlottetown, Prince Edward Island, Canada

1160.86.42002 Boehringer Ingelheim Investigational Site

Prague, Czechia

1160.86.35801 Boehringer Ingelheim Investigational Site

Jyväskylä, Finland

1160.86.31002 Boehringer Ingelheim Investigational Site

Hilversum, Netherlands

1160.86.46002 Boehringer Ingelheim Investigational Site

Hässleholm, Sweden

1160.86.46001 Boehringer Ingelheim Investigational Site

Mölndal, Sweden

Key Dates

Start Date

August 1, 2010

Primary Completion Date

April 1, 2013

Completion Date

April 1, 2013

Last Updated

September 25, 2018

Enrollment

142

ACTUAL participants

Conditions

Arthroplasty, ReplacementPrevention of Venous ThromboembolismModerate Renal Impairment (CrCl 30-50 mL/Min)

Interventions

Dabigatran etexilate

DRUG

Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement

NCT07058623

Arthroplasty, Replacement, KneeOsteoarthritis, Knee

View study

RECRUITINGPHASE2/PHASE3

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

NCT05169229

Arthroplasty, Replacement, HipOsteoarthritis, Hip+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

Low Concentration Local Anesthesia Fascia Iliaca Block for Total Hip Arthroplasty

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