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

25. august 2015 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

472

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • Basildon, Det Forenede Kongerige
        • 1160.84.04405 Boehringer Ingelheim Investigational Site
      • Bedford, Det Forenede Kongerige
        • 1160.84.04408 Boehringer Ingelheim Investigational Site
      • Luton, Det Forenede Kongerige
        • 1160.84.04403 Boehringer Ingelheim Investigational Site
      • Wigan, Det Forenede Kongerige
        • 1160.84.04401 Boehringer Ingelheim Investigational Site
      • Yeovil, Det Forenede Kongerige
        • 1160.84.04407 Boehringer Ingelheim Investigational Site
  • Frankrig
      • Angers, Frankrig
        • 1160.84.3311 Boehringer Ingelheim Investigational Site
      • Bordeaux, Frankrig
        • 1160.84.3334 Boehringer Ingelheim Investigational Site
      • Caen Cedex 5, Frankrig
        • 1160.84.3303 Boehringer Ingelheim Investigational Site
      • Clermont-Ferrand cedex 1, Frankrig
        • 1160.84.3314 Boehringer Ingelheim Investigational Site
      • Creteil, Frankrig
        • 1160.84.3320 Boehringer Ingelheim Investigational Site
      • DIJON Cédex, Frankrig
        • 1160.84.3307 Boehringer Ingelheim Investigational Site
      • Illkirch, Frankrig
        • 1160.84.3310 Boehringer Ingelheim Investigational Site
      • Le Havre, Frankrig
        • 1160.84.3335 Boehringer Ingelheim Investigational Site
      • Les Lilas, Frankrig
        • 1160.84.3326 Boehringer Ingelheim Investigational Site
      • Lyon, Frankrig
        • 1160.84.3312 Boehringer Ingelheim Investigational Site
      • Marseille, Frankrig
        • 1160.84.3305 Boehringer Ingelheim Investigational Site
      • Nantes Cédex 2, Frankrig
        • 1160.84.3323 Boehringer Ingelheim Investigational Site
      • Paris, Frankrig
        • 1160.84.3302 Boehringer Ingelheim Investigational Site
      • Paris, Frankrig
        • 1160.84.3306 Boehringer Ingelheim Investigational Site
      • Pierre Bénite cedex, Frankrig
        • 1160.84.3313 Boehringer Ingelheim Investigational Site
      • Poitiers Cédex, Frankrig
        • 1160.84.3324 Boehringer Ingelheim Investigational Site
      • Saint Etienne Cédex 2, Frankrig
        • 1160.84.3322 Boehringer Ingelheim Investigational Site
      • Saint Saulve, Frankrig
        • 1160.84.3319 Boehringer Ingelheim Investigational Site
      • Toulouse Cédex 9, Frankrig
        • 1160.84.3316 Boehringer Ingelheim Investigational Site
      • Vannes Cédex, Frankrig
        • 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
  • 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
  • Østrig
      • Wien, Østrig
        • 1160.84.4301 Boehringer Ingelheim Investigational Site
      • Wien, Østrig
        • 1160.84.4310 Boehringer Ingelheim Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Moderate renal insufficiency

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Renal Impairment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Patients With Major Bleeding Events (MBE)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2009

Primær færdiggørelse (Faktiske)

1. juli 2014

Studieafslutning (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først indsendt

18. februar 2009

Først indsendt, der opfyldte QC-kriterier

18. februar 2009

Først opslået (Skøn)

19. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1160.84

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Finland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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