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

NCT00847301 | Completed Results

• 1 other identifier: 1160.84
• Study Type: observational
• Target: 472
• Locations: 7 countries
• Sites: 53

Brief 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

Conditions

Arthroplasty, Replacement; Thromboembolism

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Documented Symptomatic Proximal DVT, 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

• 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

• Volume of Wound Drainage (Post-operative)

  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

Study Arms (1)

Renal Impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate renal insufficiency

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (53)

1160.84.4301 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.84.4310 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.84.3311 Boehringer Ingelheim Investigational Site

Angers, France

Location

1160.84.3334 Boehringer Ingelheim Investigational Site

Bordeaux, France

Location

1160.84.3303 Boehringer Ingelheim Investigational Site

Caen, France

Location

1160.84.3314 Boehringer Ingelheim Investigational Site

Clermont-Ferrand, France

Location

1160.84.3320 Boehringer Ingelheim Investigational Site

Créteil, France

Location

1160.84.3307 Boehringer Ingelheim Investigational Site

Dijon Cédex, France

Location

1160.84.3310 Boehringer Ingelheim Investigational Site

Illkirch-Graffenstaden, France

Location

1160.84.3335 Boehringer Ingelheim Investigational Site

Le Havre, France

Location

1160.84.3326 Boehringer Ingelheim Investigational Site

Les Lilas, France

Location

1160.84.3312 Boehringer Ingelheim Investigational Site

Lyon, France

Location

1160.84.3305 Boehringer Ingelheim Investigational Site

Marseille, France

Location

1160.84.3323 Boehringer Ingelheim Investigational Site

Nantes Cédex 2, France

Location

1160.84.3302 Boehringer Ingelheim Investigational Site

Paris, France

Location

1160.84.3306 Boehringer Ingelheim Investigational Site

Paris, France

Location

1160.84.3313 Boehringer Ingelheim Investigational Site

Pierre-Bénite, France

Location

1160.84.3324 Boehringer Ingelheim Investigational Site

Poitiers Cédex, France

Location

1160.84.3322 Boehringer Ingelheim Investigational Site

Saint Etienne Cédex 2, France

Location

1160.84.3319 Boehringer Ingelheim Investigational Site

Saint-Saulve, France

Location

1160.84.3316 Boehringer Ingelheim Investigational Site

Toulouse Cédex 9, France

Location

1160.84.3332 Boehringer Ingelheim Investigational Site

Vannes Cédex, France

Location

1160.84.04903 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1160.84.04947 Boehringer Ingelheim Investigational Site

Erlangen, Germany

Location

1160.84.4922 Boehringer Ingelheim Investigational Site

Gelnhausen, Germany

Location

1160.84.04927 Boehringer Ingelheim Investigational Site

Hachenburg, Germany

Location

1160.84.04929 Boehringer Ingelheim Investigational Site

Koblenz, Germany

Location

1160.84.04902 Boehringer Ingelheim Investigational Site

Marburg, Germany

Location

1160.84.04946 Boehringer Ingelheim Investigational Site

München, Germany

Location

1160.84.04913 Boehringer Ingelheim Investigational Site

Olsberg, Germany

Location

1160.84.04914 Boehringer Ingelheim Investigational Site

Sylt, Germany

Location

1160.84.04938 Boehringer Ingelheim Investigational Site

Wismar, Germany

Location

1160.84.04948 Boehringer Ingelheim Investigational Site

Würzburg, Germany

Location

1160.84.03908 Boehringer Ingelheim Investigational Site

Latina, Italy

Location

1160.84.03902 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1160.84.03904 Boehringer Ingelheim Investigational Site

Monza, Italy

Location

1160.84.03909 Boehringer Ingelheim Investigational Site

Udine, Italy

Location

1160.84.3409 Boehringer Ingelheim Investigational Site

Badalona (Barcelona), Spain

Location

1160.84.3410 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1160.84.3403 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.84.3405 Boehringer Ingelheim Investigational Site

Málaga, Spain

Location

1160.84.3404 Boehringer Ingelheim Investigational Site

Pamplona, Spain

Location

1160.84.3412 Boehringer Ingelheim Investigational Site

Pozuelo de Alarcón - Madrid, Spain

Location

1160.84.3401 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1160.84.3402 Boehringer Ingelheim Investigational Site

Zaragoza, Spain

Location

1160.84.4603 Boehringer Ingelheim Investigational Site

Kungälv, Sweden

Location

1160.84.4601 Boehringer Ingelheim Investigational Site

Motala, Sweden

Location

1160.84.4604 Boehringer Ingelheim Investigational Site

Sollefteå, Sweden

Location

1160.84.04405 Boehringer Ingelheim Investigational Site

Basildon, United Kingdom

Location

1160.84.04408 Boehringer Ingelheim Investigational Site

Bedford, United Kingdom

Location

1160.84.04403 Boehringer Ingelheim Investigational Site

Luton, United Kingdom

Location

1160.84.04401 Boehringer Ingelheim Investigational Site

Wigan, United Kingdom

Location

1160.84.04407 Boehringer Ingelheim Investigational Site

Yeovil, United Kingdom

Location

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 25, 2015
• Results First Posted: September 25, 2015

Record last verified: 2015-08

Locations

SE (3); GB (5); AU (2); IT (4); ES (8); FR (20); DE (11)