Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06523959

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

Led by Clinical Urology and Epidemiology Working Group · Updated on 2025-05-28

5436

Participants Needed

1

Research Sites

238 weeks

Total Duration

On this page

Sponsors

C

Clinical Urology and Epidemiology Working Group

Lead Sponsor

H

Helsinki University Central Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided informed consent
  • Adults aged 18 years or older
  • Undergoing elective abdominal or pelvic surgery with moderate risk of venous thromboembolism and bleeding
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Active bleeding or hemorrhage in last 6 months not planned for surgery treatment
  • Conditions posing significant risk for major bleeding such as recent gastrointestinal ulcers, malignant neoplasms with high bleeding risk, recent brain or spinal injury or surgery, intracranial hemorrhage, or vascular abnormalities
  • Use of anticoagulants, antiplatelet drugs, or omega-3 supplements within 7 days before surgery or expected use within 30 days after surgery
  • Chemotherapy, radiation, or hormone therapy for cancer within past 6 months or expected within 30 days post-surgery
  • Known thrombophilia or bleeding disorders
  • Severe liver impairment (INR 1.4 or higher in last 60 days)
  • Kidney function with eGFR less than 30 mL/min/1.73 m²
  • Platelet count below 100,000/mcL
  • Hemoglobin below 9 g/dL
  • ALT levels more than twice the upper limit of normal
  • Allergy to apixaban
  • Taking strong CYP3A4 and P-glycoprotein inhibitors or inducers
  • Undergoing procedures with high risk of venous thromboembolism or bleeding
  • Previous venous thromboembolism
  • Pregnant or breastfeeding women
  • Women with menstrual periods in last 12 months not using highly reliable contraception methods
  • Previous participation in this trial
  • Any condition judged by investigators to prevent participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Helsinki University Hospital

Helsinki, Finland, 00029

Actively Recruiting

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Research Team

C

CLUE Working Group

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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