Evidence map›Paper›PMID 38413147›Full record

ArticleBMJ open2024

Protocol for a randomised controlled trial comparing warfarin with no oral anticoagulation in patients with atrial fibrillation on chronic dialysis: the Danish Warfarin-Dialysis (DANWARD) trial.

Ellen Linnea Freese Ballegaard, Kristine Lindhard, Morten Lindhardt, Christian Daugaard Peters, Finn Thomsen Nielsen, Ida Nørager Tietze, Rikke Borg, Lene Boesby, Marianne Camilla Bertelsen, Julie Maria Bøggild Brøsen and 23 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03862859 (The Danish Warfarin-Dialysis Study), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03862859 phase4recruitingnot on this map

The Danish Warfarin-Dialysis Study: Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis - A Nationwide Parallel-group Open Randomized Clinical Trial

TypeinterventionalSponsorNicholas CarlsonRan2019 to 2027Enrolled718ConditionsAtrial Fibrillation and Flutter, Stroke, Major Bleed, End-stage Renal DiseaseArmsWarfarin
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

33 authors at 13 institutions in 3 countries.

Ellen Linnea Freese BallegaardDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark ellen.linnea.freese.ballegaard@regionh.dk.ORCID 0000-0001-7827-1861
Kristine LindhardDepartment of Nephrology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark.
Morten LindhardtDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0001-6063-1718
Christian Daugaard PetersDept. of Clinical Medicine, Aarhus University, Aarhus N, Denmark.
Finn Thomsen NielsenDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Ida Nørager TietzeDepartment of Medicine, Viborg Regional Hospital, Viborg, Denmark.
Rikke BorgDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Lene BoesbyDepartment of Medicine, Zealand University Hospital, Roskilde, Denmark.
Marianne Camilla BertelsenDepartment of Endocrinology and Nephrology, Copenhagen University Hospital - North Zealand, Hillerød, Denmark.
Julie Maria Bøggild BrøsenDepartment of Endocrinology and Nephrology, Copenhagen University Hospital - North Zealand, Hillerød, Denmark.
Donata Cibulskyte-NinkovicDepartment of Nephrology, Lillebaelt Hospital, Kolding, Denmark.
Jesper Moesgaard RantanenDepartment of Nephrology, Aalborg University Hospital, Aalborg, Denmark.
Frank Holden MoseDepartment of Nephrology, Gødstrup Regional Hospital, Herning, Denmark.
Jan Dominik KampmannInternal medicine, Hospital of Southern Jutland Sonderborg Branch, Sonderborg, Denmark.
Alice Skovhede NielsenDepartment of Medicine, Esbjerg Hospital, University Hospital of Southern Denmark, Esbjerg, Denmark.
Johanne Kodal BreinholtDepartment of Clinical Biochemistry, Esbjerg Hospital, University Hospital of Southern Denmark, Esbjerg, Denmark.
Dea Haagensen KofodDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0003-0173-8456
Iain BressendorffDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Peter Vilhelm ClausenDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Theis LangeSection of Biostatistics, University of Copenhagen, Kobenhavns, Denmark.
Lars KøberDepartment of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Anne-Lise KamperDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Casper Niels Furbo BangDepartment of Cardiology, Copenhagen University Hospital - Frederiksberg and Bispebjerg, Copenhagen, Denmark.
Christian Torp-PedersenDepartment of Cardiology, Copenhagen University Hospital - North Zealand, Hillerød, Denmark.
Ditte HansenDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Erik L GroveDepartment of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Gunnar GislasonDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark.
Jens Dam JensenDepartment of Renal Medicine, Aarhus University Hospital, Aarhus N, Denmark.
Jonas Bjerring OlesenDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark.
Mads HornumDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Marianne RixDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Morten SchouDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Nicholas CarlsonDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Copenhagen University Hospital · DKUniversity of Copenhagen · DKGentofte Hospital · DKAarhus University · DKHospital South West Jutland · DKAalborg University Hospital · DKAarhus University Hospital · DKFrederiksberg Hospital · DKGeneral Department of Preventive Medicine · VNLillebaelt Hospital · DKRegionshospitalet Herning · DKRegionshospitalet Viborg · DKZealand University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAtrial fibrillation is highly prevalent in patients on chronic dialysis. It is unclear whether anticoagulant therapy for stroke prevention is beneficial in these patients. Vitamin K-antagonists (VKA) remain the predominant anticoagulant choice. Importantly, anticoagulation remains inconsistently used and a possible benefit remains untested in randomised clinical trials comparing oral anticoagulation with no treatment in patients on chronic dialysis. The Danish Warfarin-Dialysis (DANWARD) trial aims to investigate the safety and efficacy of VKAs in patients with atrial fibrillation on chronic dialysis. The hypothesis is that VKA treatment compared with no treatment is associated with stroke risk reduction and overall benefit. METHODS AND ANALYSIS: The DANWARD trial is an investigator-initiated trial at 13 Danish dialysis centres. In an open-label randomised clinical trial study design, a total of 718 patients with atrial fibrillation on chronic dialysis will be randomised in a 1:1 ratio to receive either standard dose VKA targeting an international normalised ratio of 2.0-3.0 or no oral anticoagulation. Principal analyses will compare the risk of a primary efficacy endpoint, stroke or transient ischaemic attack and a primary safety endpoint, major bleeding, in patients allocated to VKA treatment and no treatment, respectively. The first patient was randomised in October 2019. Patients will be followed until 1 year after the inclusion of the last patient. ETHICS AND DISSEMINATION: The study protocol was approved by the Regional Research Ethics Committee (journal number H-18050839) and the Danish Medicines Agency (case number 2018101877). The trial is conducted in accordance with the Helsinki declaration and standards of Good Clinical Practice. Study results will be disseminated to participating sites, at research conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: NCT03862859, EUDRA-CT 2018-000484-86 and CTIS ID 2022-502500-75-00.

Indexed as

Atrial FibrillationStrokeAnticoagulantsDenmarkHumansRandomized Controlled Trials as TopicRenal DialysisTreatment OutcomeWarfarinAnticoagulantsWarfarinAnticoagulationClinical TrialDialysisEnd stage renal failureThromboembolism

Identifiers

PMID38413147
PMCPMC10900386
OpenAlexW4392202545

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.