Oral Anticoagulation in Haemodialysis Patients

Kidney Failure, Chronic Clinical Trial

— AVKDIAL  

Official title:

Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02886962
• Other study ID #: 6396
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 12, 2017
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Formal indication to oral anticoagulation beside atrial fibrillation (mechanic heart valves, recurrent thrombophlebitis, antiphospholipid syndrome)
• Life expectancy < 6 months (e.g., terminal cancer)
• Live donor transplantation scheduled within 6 months
• Pregnancy (ß-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)
• Severe liver failure (CI to oral AVK)

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Biological:
• No oral anticoagulation
No oral anticoagulation, and no monitoring of the INR.

Drug:
• Oral anticoagulation with vitamin K antagonists
Vitamin K antagonist prescription with INR target between 2 and 3 as recommended in the guidelines. Administration once daily or at the end of each dialysis session, according to the nephrologist choice. INR monitoring at least once per week

Locations

Country	Name	City	State
France	Service de Néphrologie et médecine interne	Amiens
France	CHRU d'Angers - Service de Néphrologie	Angers
France	Service Néphrologie, Dialyse, Transplantation	Caen
France	Pathologie Rénale	Chambéry
France	Service de Néphrologie	Cherbourg-Octeville
France	Aural Colmar	Colmar
France	Service de néphrologie	Colmar
France	Service de néphrologie	Dijon
France	Aurad Aquitaine	Gradignan
France	AURAL Haguenau	Haguenau
France	Centre Hospitalier de Haguenau - service de Néphrologie	Haguenau
France	Centre Hospitalier Emile Roux	Le Puy-en-Velay
France	Clinique Bouchard	Marseille
France	Service de Néphrologie	Nancy
France	ECHO de Nantes	Nantes
France	Service de Néphrologie	Nantes
France	AURA Paris Plaisance	Paris
France	Hôpital Tenon - Service de Néphrologie	Paris
France	Service de néphrologie	Rennes
France	ECHO CA Laennec	Saint-Herblain
France	NéphroCare Tassin-Charcot	Sainte-Foy-lès-Lyon
France	AURAL st Anne	Strasbourg
France	Service de Néphrologie	Strasbourg
France	Centre Hospitalier Bretagne-Atlantique	Vannes
France	Calydial CH Lucien Hussel	Vienne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation		2 years