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

25 augusti 2015 uppdaterad av: Boehringer Ingelheim

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

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

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Observationell

Inskrivning (Faktisk)

472

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Moderate renal insufficiency

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Renal Impairment

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Patients With Major Bleeding Events (MBE)
Tidsram: 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
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
Tidsram: 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
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality
Tidsram: 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 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
Percentage of Patients With Major Extra-surgical Site Bleedings
Tidsram: 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)
Tidsram: 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 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Boehringer Ingelheim

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2009

Primärt slutförande (Faktisk)

1 juli 2014

Avslutad studie (Faktisk)

1 juli 2014

Studieregistreringsdatum

Först inskickad

18 februari 2009

Först inskickad som uppfyllde QC-kriterierna

18 februari 2009

Första postat (Uppskatta)

19 februari 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

25 september 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 augusti 2015

Senast verifierad

1 augusti 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1160.84

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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