Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery

Thromboembolism Clinical Trial

Official title:

Observational Cohort Study to Evaluate Safety and Efficacy of Pradaxa (Dabigatran Etexilate) in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847301
• Other study ID #: 1160.84
• Status: Completed
• Phase: N/A
• First received: February 18, 2009
• Last updated: August 25, 2015
• Start date: April 2009
• Est. completion date: July 2014

Study information

• Verified date: August 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Medicines and Medical Devices AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: Ethics CommitteeSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

Patients of 18 years of age or above with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing elective total hip replacement surgery who consent in writing to their participation in this observational study

Exclusion criteria:

All patients who should not be treated with Pradaxa 150 mg according to the European Summary of Product Characteristics (SPC):

severe renal impairment (creatinine clearance < 30 ml/min); elevated liver enzymes > 2 upper limit of normal (ULN); Hepatic impairment or liver disease expected to have any impact on survival, anaesthesia with post-operative indwelling epidural catheters, hypersensitivity to dabigatran etexilate or to any of the excipients, active clinically significant bleeding, organic lesion at risk of bleeding, spontaneous or pharmacological impairment of haemostasis, concomitant treatment with quinidine, protehetic heart valve requiring anticoagulant treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthroplasty, Replacement
• Renal Insufficiency
• Thromboembolism

Locations

Country	Name	City	State
Austria	1160.84.4301 Boehringer Ingelheim Investigational Site	Wien
Austria	1160.84.4310 Boehringer Ingelheim Investigational Site	Wien
France	1160.84.3311 Boehringer Ingelheim Investigational Site	Angers
France	1160.84.3334 Boehringer Ingelheim Investigational Site	Bordeaux
France	1160.84.3303 Boehringer Ingelheim Investigational Site	Caen Cedex 5
France	1160.84.3314 Boehringer Ingelheim Investigational Site	Clermont-Ferrand cedex 1
France	1160.84.3320 Boehringer Ingelheim Investigational Site	Creteil
France	1160.84.3307 Boehringer Ingelheim Investigational Site	DIJON Cédex
France	1160.84.3310 Boehringer Ingelheim Investigational Site	Illkirch
France	1160.84.3335 Boehringer Ingelheim Investigational Site	Le Havre
France	1160.84.3326 Boehringer Ingelheim Investigational Site	Les Lilas
France	1160.84.3312 Boehringer Ingelheim Investigational Site	Lyon
France	1160.84.3305 Boehringer Ingelheim Investigational Site	Marseille
France	1160.84.3323 Boehringer Ingelheim Investigational Site	Nantes Cédex 2
France	1160.84.3302 Boehringer Ingelheim Investigational Site	Paris
France	1160.84.3306 Boehringer Ingelheim Investigational Site	Paris
France	1160.84.3313 Boehringer Ingelheim Investigational Site	Pierre Bénite cedex
France	1160.84.3324 Boehringer Ingelheim Investigational Site	Poitiers Cédex
France	1160.84.3322 Boehringer Ingelheim Investigational Site	Saint Etienne Cédex 2
France	1160.84.3319 Boehringer Ingelheim Investigational Site	Saint Saulve
France	1160.84.3316 Boehringer Ingelheim Investigational Site	Toulouse Cédex 9
France	1160.84.3332 Boehringer Ingelheim Investigational Site	Vannes Cédex
Germany	1160.84.04903 Boehringer Ingelheim Investigational Site	Berlin
Germany	1160.84.04947 Boehringer Ingelheim Investigational Site	Erlangen
Germany	1160.84.4922 Boehringer Ingelheim Investigational Site	Gelnhausen
Germany	1160.84.04927 Boehringer Ingelheim Investigational Site	Hachenburg
Germany	1160.84.04929 Boehringer Ingelheim Investigational Site	Koblenz
Germany	1160.84.04902 Boehringer Ingelheim Investigational Site	Marburg
Germany	1160.84.04946 Boehringer Ingelheim Investigational Site	München
Germany	1160.84.04913 Boehringer Ingelheim Investigational Site	Olsberg
Germany	1160.84.04914 Boehringer Ingelheim Investigational Site	Sylt
Germany	1160.84.04938 Boehringer Ingelheim Investigational Site	Wismar
Germany	1160.84.04948 Boehringer Ingelheim Investigational Site	Würzburg
Italy	1160.84.03908 Boehringer Ingelheim Investigational Site	Latina
Italy	1160.84.03902 Boehringer Ingelheim Investigational Site	Milano
Italy	1160.84.03904 Boehringer Ingelheim Investigational Site	Monza
Italy	1160.84.03909 Boehringer Ingelheim Investigational Site	Udine
Spain	1160.84.3409 Boehringer Ingelheim Investigational Site	Badalona (Barcelona)
Spain	1160.84.3410 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1160.84.3403 Boehringer Ingelheim Investigational Site	Madrid
Spain	1160.84.3405 Boehringer Ingelheim Investigational Site	Malaga
Spain	1160.84.3404 Boehringer Ingelheim Investigational Site	Pamplona
Spain	1160.84.3412 Boehringer Ingelheim Investigational Site	Pozuelo de Alarcón - Madrid
Spain	1160.84.3401 Boehringer Ingelheim Investigational Site	Valencia
Spain	1160.84.3402 Boehringer Ingelheim Investigational Site	Zaragoza
Sweden	1160.84.4603 Boehringer Ingelheim Investigational Site	Kungälv
Sweden	1160.84.4601 Boehringer Ingelheim Investigational Site	Motala
Sweden	1160.84.4604 Boehringer Ingelheim Investigational Site	Sollefteå
United Kingdom	1160.84.04405 Boehringer Ingelheim Investigational Site	Basildon
United Kingdom	1160.84.04408 Boehringer Ingelheim Investigational Site	Bedford
United Kingdom	1160.84.04403 Boehringer Ingelheim Investigational Site	Luton
United Kingdom	1160.84.04401 Boehringer Ingelheim Investigational Site	Wigan
United Kingdom	1160.84.04407 Boehringer Ingelheim Investigational Site	Yeovil

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Major Bleeding Events (MBE)	Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation	From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa	Yes
Primary	Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality	The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE) and All Cause Mortality.	From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa	No
Secondary	Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality	Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality	From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa	No
Secondary	Percentage of Patients With Major Extra-surgical Site Bleedings	Percentage of Patients With Major Extra-surgical Site Bleedings	From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa	Yes
Secondary	Volume of Wound Drainage (Post-operative)	Volume of Wound Drainage after surgery	From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa	Yes