Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523959
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
Avoiding Risks of Thrombosis and Bleeding in Surgery ARTS Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARTS
Brief 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 5436 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
Detailed Description:
Deep vein thrombosis and pulmonary embolism - collectively known as venous thromboembolism VTE - and major bleeding are serious surgical complications leading to poorer patient-reported quality of life and mortality Pharmacological thromboprophylaxis is an established strategy for reducing VTE risk but balancing it with increased bleeding particularly after major surgery poses challenges Guidelines typically recommend pharmacological thromboprophylaxis for patients at higher but not lower risk of VTE without clearly defining procedure or patient selection There is particular uncertainty regarding the balance of potential benefits and harms of pharmacological thromboprophylaxis in patients who are at a lower estimated risk of VTE postoperatively in patients with a baseline VTE risk in the range of 2 In these patients the risk of major bleeding may be similar to or could potentially outweigh the relatively lower risk of VTE complications such that the net clinical benefit of routine pharmacological thromboprophylaxis remains unclear
Avoiding Risks of Thrombosis and Bleeding in Surgery ARTS is a large randomized multicenter study comparing a direct oral anticoagulant DOAC called apixaban in patients undergoing abdominal and pelvic surgeries Half of the 5436 patients will be randomized to receive apixaban after surgery for 28 days with standard of care mechanical prophylaxis - to a control group with no anticoagulation but with standard of care mechanical prophylaxis
ARTS trial will be the first to compare anticoagulation with DOACs apixaban versus no anticoagulation in a population of urologic gynecologic and abdominal surgical patients Any of the possible outcomes of 1 A clear net benefit in favor of apixaban or 2 A clear net benefit to not using prophylaxis or 3 a sufficiently close tradeoff that predictive factors and patients values and preferences regarding bleeding versus thrombosis determines the decision will substantially enhance evidence-based peri-operative care
Avoiding Risks of Thrombosis and Bleeding in Surgery ARTS is a large randomized multicenter study comparing a direct oral anticoagulant DOAC called apixaban in patients undergoing abdominal and pelvic surgeries Half of the 5436 patients will be randomized to receive apixaban after surgery for 28 days with standard of care mechanical prophylaxis - to a control group with no anticoagulation but with standard of care mechanical prophylaxis
ARTS trial will be the first to compare anticoagulation with DOACs apixaban versus no anticoagulation in a population of urologic gynecologic and abdominal surgical patients Any of the possible outcomes of 1 A clear net benefit in favor of apixaban or 2 A clear net benefit to not using prophylaxis or 3 a sufficiently close tradeoff that predictive factors and patients values and preferences regarding bleeding versus thrombosis determines the decision will substantially enhance evidence-based peri-operative care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None