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Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial

NCT06523959 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5436

Last updated 2025-05-28

No results posted yet for this study

Summary

Avoiding Risks of Thrombosis and bleeding in Surgery (ARTS) trial is a pragmatic, international, multicenter, randomized controlled open label trial comparing a direct oral anticoagulant (DOAC) - oral factor Xa inhibitor apixaban - to no anticoagulant among 5,436 patients undergoing abdominal or pelvic surgery at sufficiently similar (and not high) risk of venous thromboembolism (VTE) and bleeding that the net impact - benefit or harm - of thromboprophylaxis remains in doubt.

Conditions

Interventions

DRUG

Apixaban 2.5 MG

To evaluate the benefits and risks of thromboprophylaxis with oral factor Xa inhibitor Apixaban compared to No anticoagulation

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • University of Helsinki

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • Population Health Research Institute

    collaborator OTHER

  • Tabriz University of Medical Sciences

    collaborator OTHER

  • Tampere University Hospital

    collaborator OTHER

  • Turku University Hospital

    collaborator OTHER_GOV

  • Oulu University Hospital

    collaborator OTHER

  • North Karelia Central Hospital

    collaborator OTHER

  • Albany Medical College

    collaborator OTHER

  • PaijatHame Central Hospital

    collaborator OTHER

  • Clinical Urology and Epidemiology Working Group

    lead OTHER_GOV

Principal Investigators

  • Kari AO Tikkinen, Professor · University of Helsinki and Helsinki University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-06
Primary Completion
2028-09-30
Completion
2028-12-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06523959 on ClinicalTrials.gov