Kidney Failure, Chronic
Conditions
Brief 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.
Interventions
BIOLOGICALNo oral anticoagulation
No oral anticoagulation, and no monitoring of the INR.
DRUGOral 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
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (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) * Severe liver failure (CI to oral AVK)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation | 2 years |
Countries
France
Outcome results
None listed