Oral Anticoagulation in Haemodialysis Patients

  • STATUS
    Recruiting
  • End date
    Jan 25, 2023
  • participants needed
    855
  • sponsor
    University Hospital, Strasbourg, France
Updated on 25 January 2021
vitamins

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.

Details
Condition Chronic renal failure, end stage renal disease, chronic renal disease, end-stage renal disease, esrd, end-stage renal failure, end stage kidney disease, end stage renal failure
Treatment No oral anticoagulation, Oral anticoagulation with vitamin K antagonists
Clinical Study IdentifierNCT02886962
SponsorUniversity Hospital, Strasbourg, France
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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 (-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)
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