Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial (NCT06523959) | Clinical Trial Compass
RecruitingPhase 4
Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial
Finland5,436 participantsStarted 2024-06-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed consent provided
* Adult patients (≥18 years);
* Undergoing elective abdominal or pelvic surgery at similar (and not high) risk of VTE and bleeding
Exclusion Criteria:
* Inability to provide informed consent
* Patient with active bleeding/hemorrhage during the last 6 months if not expected to be treated by surgery planned
* Lesion or condition if considered a significant risk factor for major bleeding
a. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
* Anticoagulant treatment, antiplatelet treatment or omega-3 dietary supplement during previous 7 days preceding surgery and/or requiring within 30 days post-surgery
* Patient who had during previous 6 months or are expected require within 30 days post-surgery chemotherapy/radiation or hormone therapy for cancer
* Known thrombophilia
* Known bleeding disorder
* Substantial liver impairment (for instance INR 1.4 or more during last 60 days)
* eGRF \<30 mL/min/1.73 m2
* Platelet count \<100 × 109/L (that is, 100 000 mg/L)
* Hb \<90 g/L (that is, \<9 g/dL)
* ALT \>2 × upper limit of normal
* Known allergy to apixaban
* Taking strong inhibitors or inductors of both CYP 3A…
What they're measuring
1
Incidence composite outcome of venous thromboembolism (VTE)
Timeframe: 90 days
Trial details
NCT IDNCT06523959
SponsorClinical Urology and Epidemiology Working Group