Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial
NCT Number: NCT06523959
Acronym: ARTS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Venous Thromboembolism|Bleeding
Interventions: DRUG: Apixaban 2.5 MG
Sponsor: Clinical Urology and Epidemiology Working Group
Collaborators: Helsinki University Central Hospital|University of Helsinki|University College, London|Population Health Research Institute|Tabriz University of Medical Sciences|Tampere University Hospital|Turku University Hospital|Oulu University Hospital|North Karelia Central Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5436
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-06
Completion Date: 2028-12-31
Locations: Helsinki University Hospital, Helsinki, 00029, Finland

Summary:
The ARTS trial is a pragmatic, international, multicenter, randomized controlled open label trial comparing a 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 VTE and bleeding that the net impact - benefit or harm - of thromboprophylaxis remains in doubt.

Primary Outcome Measures: Incidence composite outcome of venous thromboembolism (VTE), Defined as symptomatic deep vein thrombosis (DVT), or symptomatic non-fatal or fatal pulmonary embolism (PE), 90 days
Secondary Outcome Measures: Incidence of symptomatic DVT, Defined as symptomatic deep vein thrombosis, 90 days|Incidence of symptomatic PE, Defined as symptomatic non-fatal of fatal pulmonary embolism (PE), 90 days
Other Outcome Measures: Incidence of composite endpoint for major bleeding, Defined as composite endpoint of bleeding leading to a postoperative hemoglobin \<70 g/L, transfusion of ≥1 unit of red blood cells, or bleeding that was judged to be the immediate cause of death, 90 days|Incidence of re-intervention or endovascular embolization to stop bleeding, Defined as bleeding requiring re-intervention or endovascular embolization to stop bleeding, 90 days|Incidence of composite outcome of VTE, Defined as symptomatic DVT, or symptomatic non-fatal or fatal PE, 30 days|Incidence of composite endpoint for major bleeding, Defined as composite endpoint of bleeding leading to a postoperative hemoglobin \<70 g/L, transfusion of ≥1 unit of red blood cells, or bleeding that was judged to be the immediate cause of death, 30 days|Incidence of re-intervention or endovascular embolization to stop bleeding, Defined as bleeding requiring re-intervention or endovascular embolization to stop bleeding, 30 days|Incidence of symptomatic non-fatal PE, Defined as symptomatic non-fatal pulmonary embolism, 90 days|Incidence of symptomatic fatal PE, Defined as fatal pulmonary embolism, 90 days|Incidence of bleeding leading to a postoperative hemoglobin <70 g/L, 90 days|Incidence of transfusion of ≥1 unit of red blood cells, 90 days|Incidence of bleeding that was judged to be the immediate cause of death, 90 days|Incidence of bleeding requiring re-intervention to stop bleeding, 90 days|Incidence of bleeding requiring endovascular embolization to stop bleeding, 90 days|Overall mortality, 90 days|Incidence of SUSARs potentially related to the study drug (apixaban), 90 days|Incidence of Serious Adverse Events (SAEs), any, 90 days|Incidence of any potentially drug-related SAEs (serious), cardiac complications, cerebral complications, infectious complications, admittance to intensive care, reoperation or other intervention for other reason than bleeding and other complication, 90 days|Incidence of critical organ bleeding, 90 days|Cost-effectiveness of DOAC administration, The trial will also assess the cost-effectiveness of apixaban administration compared to no pharmacological thromboprophylaxis. An extended time horizon decision analytic model will evaluate the costs associated with VTE and bleeding events in both trial arms. Based on these analyses, the additional or saved costs per quality- adjusted life-year (QALY) will be determined for various trial outcomes, including scenarios where apixaban is superior to no pharmacological thromboprophylaxis or vice versa. Costs will be evaluated from the perspective of national health service in selected countries. This assessment will consider patient healthcare resource utilisation, staff training costs (e.g., administering subcutaneous injections), and medication costs. The benefits of the interventions will be measured in terms of clinical outcomes, such as the reduction in VTE events and complications (including VTE and bleeding events). Additionally, QoL information will be used to calculate QALYs., 90 days