Oral Anticoagulation in Haemodialysis Patients
Reason given: not enough patients
Key facts
- Where
- Amiens, Angers, Caen, Chambéry, Cherbourg-Octeville, Colmar, Dijon, Gradignan, Haguenau, Le Puy-en-Velay, Marseille, Nancy, Nantes, Paris, Rennes, Saint-Herblain, Sainte-Foy-lès-Lyon, Strasbourg, Vannes, and Vienne, FranceSee the 25 sites
- Phase
- Phase 4
Where in France
- Service de Néphrologie et médecine interneAmiens, FranceNo longer taking part
- CHRU d'Angers - Service de NéphrologieAngers, FranceNo longer taking part
- Service Néphrologie, Dialyse, TransplantationCaen, FranceNo longer taking part
- Pathologie RénaleChambéry, FranceNo longer taking part
- Service de NéphrologieCherbourg-Octeville, FranceNo longer taking part
- Aural ColmarColmar, FranceNo longer taking part
- Service de néphrologieColmar, FranceNo longer taking part
- Service de néphrologieDijon, FranceNo longer taking part
- AURAD AquitaineGradignan, FranceNo longer taking part
- AURAL HaguenauHaguenau, FranceNo longer taking part
- Centre Hospitalier de Haguenau - service de NéphrologieHaguenau, FranceNo longer taking part
- Centre Hospitalier Emile RouxLe Puy-en-Velay, FranceNo longer taking part
- Clinique BouchardMarseille, FranceNo longer taking part
- Service de NéphrologieNancy, FranceNo longer taking part
- ECHO de NantesNantes, FranceNo longer taking part
- Service de NéphrologieNantes, FranceNo longer taking part
- AURA Paris - PlaisanceParis, FranceNo longer taking part
- Hôpital Tenon - Service de NéphrologieParis, FranceNo longer taking part
- Service de néphrologieRennes, FranceNo longer taking part
- ECHO CA LaennecSaint-Herblain, FranceNo longer taking part
- NéphroCare Tassin-CharcotSainte-Foy-lès-Lyon, FranceNo longer taking part
- AURAL st AnneStrasbourg, FranceNo longer taking part
- Service de néphrologieStrasbourg, FranceNo longer taking part
- Centre Hospitalier Bretagne AtlantiqueVannes, FranceNo longer taking part
- Calydial CH Lucien HusselVienne, FranceNo longer taking part
Trial details
- Who runs it
- University Hospital, Strasbourg, France
- Trial code
- NCT02886962
- Record updated
- 20 August 2024
- Original description
Guidelines recommend oral anticoagulation with vitamin K antagonists for atrial fibrillation whenever the CHADS2VASC score is superior or equal to 2. As there are no specific guidelines for the hemodialysis patients with atrial fibrillation, the general guidelines apply. However, several retrospective studies suggest that these patients do not benefit from the oral anticoagulation regarding the risk of stroke and may even experience more bleedings and deaths.Read full original descriptionShow less
Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation
Guidelines recommend oral anticoagulation with vitamin K antagonists for atrial fibrillation whenever the CHADS2VASC score is superior or equal to 2. As there are no specific guidelines for the hemodialysis patients with atrial fibrillation, the general guidelines apply. However, several retrospective studies suggest that these patients do not benefit from the oral anticoagulation regarding the risk of stroke and may even experience more bleedings and deaths.
The aim of this prospective study is to prospectively compare the hemorrhagic and thrombotic risks of oral anticoagulation in comparison with no anticoagulation in hemodialysis patients with atrial fibrillation.
Inclusion: Adult patients (≥ 18 years); Patient on hemodialysis treatment for at least 1 month; Patient with a history of, or presenting a new episode of atrial fibrillation (either permanent or paroxysmal); Patient with a CHADS2VASC score ≥2; Patient with high risk of bleeding as defined by (1) HASBLED score ≥3 OR (2) HASBLED ≥ CHADS2VASC score, OR (3) recent history of severe bleeding (type 3a, 3b, 3c), particularly cerebral or gastrointestinal, OR (4) prior recurrent (>2) history of falls; Patient capable of understanding information about the study and of giving his/her consent; Patient informed of the preliminary medical exam results; Patient with healthcare insurance; Written consent signed.
Exclusion: Live donor transplantation scheduled within 6 months; Formal indication to oral anticoagulation beside atrial fibrillation (mechanic heart valves, recurrent thrombophlebitis, antiphospholipid syndrome); Life expectancy < 6 months (e.g., terminal cancer); Severe liver failure (CI to oral AVK); Pregnancy (β-HCG blood-based assay)or nursing (lactating) women; Women of child bearing potential, unless they are using an effective method of birth control; Patient under legal guardianship; Patients under law protection; Known hypersensibility to coumadin or indoine derivatives or to any excipients (CI to oral AVK).