Actively Recruiting
Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial: An International Randomised Controlled Trial Evaluating Apixaban Versus No Anticoagulation in Patients Undergoing General Abdominal, Gynecologic and Urologic Surgery
Led by Clinical Urology and Epidemiology Working Group · Updated on 2025-05-28
5436
Participants Needed
1
Research Sites
13 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
Researchers are evaluating the use of a direct oral anticoagulant (DOAC) called apixaban compared to no anticoagulant in patients undergoing abdominal or pelvic surgery. This international, multicenter, randomized controlled trial focuses on patients with a moderate risk of venous thromboembolism (VTE) and bleeding where the benefits and harms of thromboprophylaxis are unclear. The study aims to clarify whether apixaban provides a net benefit or if avoiding anticoagulation is preferable in this population. The trial enrolls 5,436 patients who will be randomly assigned to receive either apixaban 2.5 mg orally twice daily for 28 days alongside standard mechanical prevention or no anticoagulant with standard mechanical prevention alone. Mechanical prophylaxis is provided as standard care in both groups. The study is open-label and compares the outcomes of using apixaban versus no anticoagulation after surgery. Participants will be monitored for 90 days to assess the incidence of VTE, including deep vein thrombosis and pulmonary embolism. Researchers will collect data on symptomatic events and major bleeding. Follow-up visits and assessments will track safety and effectiveness outcomes. The study’s results will help guide decisions about thromboprophylaxis after abdominal and pelvic surgeries in patients at moderate risk.
CONDITIONS
Brief Title
Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent provided
- Adult patients (18 years or older)
- Undergoing elective abdominal or pelvic surgery at similar (and not high) risk of venous thromboembolism and bleeding
You will not qualify if you...
- Inability to provide informed consent
- Active bleeding or hemorrhage within the last 6 months unless expected to be treated by planned surgery
- Lesion or condition posing significant risk of major bleeding, such as recent gastrointestinal ulceration, malignant neoplasms at high bleeding risk, recent brain or spinal injury or surgery, intracranial hemorrhage, or vascular abnormalities
- Use of anticoagulant, antiplatelet, or omega-3 supplements within 7 days before surgery or requiring within 30 days after surgery
- Chemotherapy, radiation, or hormone therapy for cancer within 6 months prior or expected within 30 days post-surgery
- Known thrombophilia or bleeding disorder
- Significant liver impairment (INR 1.4 or more within last 60 days)
- Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2
- Platelet count below 100,000 per microliter
- Hemoglobin below 9 g/dL
- Alanine aminotransferase (ALT) greater than twice the upper limit of normal
- Allergy to apixaban
- Use of strong CYP 3A4 and P-glycoprotein inhibitors or inducers
- Undergoing procedures with high risk of venous thromboembolism or bleeding
- Previous venous thromboembolism
- Pregnant or breastfeeding females
- Females with menstrual periods in last 12 months not using highly reliable contraception
- Previous randomization in this trial
- Any other reason investigator judges patient should not participate
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive either apixaban orally twice daily for 28 days with standard mechanical prophylaxis or no anticoagulation with standard mechanical prophylaxis after surgery.
1 baseline visit and approximately 1 follow-up visit during treatment
Duration - Up to 90 days after surgery
Participants are monitored for venous thromboembolism and bleeding events after treatment ends.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Helsinki University Hospital
Helsinki, Finland, 00029
Actively Recruiting
Research Team
C
CLUE Working Group
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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