BACKGROUND: The Dialysis Access Consortium (DAC) was developed to investigate interventions to improve hemodialysis vascular access outcomes. The autogenous arteriovenous @entity292 created by direct connection of native artery to vein is the recommended vascular access for hemodialysis. However, it fails frequently due to clotting after surgery. PURPOSE: The DAC Early AV Fistula @entity715 Trial tests the hypothesis that @entity1397 can prevent early @entity292 failure and increase the number of @entity292 that ultimately become usable for hemodialysis access. This is one of two initial and concurrent trials being performed by the DAC. The companion trial investigates pharmacologic approaches to prevent @entity1211 leading to AV graft failure. METHODS: This is a multicenter, randomized, double-blind, placebo-controlled trial that will enroll 1,284 @entity1 over four years. @entity1 undergoing creation of a new native arteriovenous (AV) @entity292 are randomized to treatment with @entity1397 or placebo for six weeks following @entity292 creation surgery. The primary outcome is @entity292 patency at six weeks. The major secondary outcome is @entity292 suitability for dialysis. RESULTS: This paper examines key aspects of this study that have broad relevance to trial design including: 1) the selection of an intermediate event as the primary outcome, 2) timing of the intervention to balance efficacy and safety concerns, 3) ethical considerations arising from required modifications of concomitant drug therapy, and 4) choosing an efficacy or effectiveness evaluation of the intervention. CONCLUSIONS: This is the first, large, multicenter trial evaluating a pharmacologic approach to prevent early @entity2548 failure and promote more usable @entity292 for hemodialysis. The methodologic challenges identified and addressed during the development of this trial should help to inform the design of future vascular access trials, and are relevant to clinical trials addressing a wide range of questions.

Design of the Dialysis Access Consortium (DAC) @entity1397 Prevention of Early AV Fistula XXXX Trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity1397 :: ('MESH:C055162', 'Chemical') :: ['clopidogrel'] @entity292 :: ('MESH:D005402', 'Disease') :: ['fistula', 'fistulas'] @entity715 :: ('MESH:D013927', 'Disease') :: ['Thrombosis'] @entity2548 :: ('MESH:D001164', 'Disease') :: ['AV fistula'] @entity1211 :: ('MESH:D054556', 'Disease') :: ['venous stenosis']
@entity715 :: (MESH:D013927,Disease) :: ['Thrombosis']
