Propaten Randomized Investigation on Cost-benefit and Efficacy (PRICE)

A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Heparin-bonded Versus Non-heparin-bonded Polytetrafluroethylene Hemodialysis Access Grafts.

Results from futility analysis conducted at planned interim time-point did not meet the study criteria for continuation.

The purpose for this study is to evaluate the patency and outcomes of conventional and heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.

Study Design: This is a prospective, multi-institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing heparin-bonded (Propaten®) versus non-heparin-bonded arteriovenous grafts. Procedure: In patients without usable native vein, prosthetic arteriovenous grafts will be implanted for hemodialysis access. Patients will be randomized intraoperatively to either conventional (Gore® Stretch) or heparin-bonded grafts (Gore® Propaten). Course of Study: The study will accrue patients over the course of 5 years. Enrollment: Enrollment will consist of adult patients who require hemodialysis. If the patient cannot have a native vein arteriovenous fistula, the patient is a candidate for arteriovenous graft. Patients will be screened and consented preoperatively. If the intraoperative decision is made that the patient will require a graft, randomization will occur and the patient will be considered enrolled. Recruitment: The target population comprises of all adult patients aged 18 years and above with end stage renal disease requiring arteriovenous access for hemodialysis. The target for enrollment will be 200 patients. Risks: The standard or known adverse events associated with graft implantation include thrombosis, infection, pseudoaneurysm, hematoma, and venous stenosis. There are case reports of heparin sensitivity. The investigators do not expect any additional physical risks other than an unintentional disclosure of sensitive patient health information. Data Safety Monitoring: As the Principal Investigator of this study, Dr. Charlton-Ouw from the Department of Cardiothoracic and Vascular Surgery at The University of Texas at Houston Medical School will conduct the data safety monitoring of this study. He will annually meet with all other co-investigators to review the patients enrolled in this study. As part of the data safety monitoring plan, all patients enrolled until that point in time would be unblinded in order to review the outcomes. Interim analyses will be conducted at the one-year follow up time. IND#: The devices that will be used are already approved by the FDA and do not have IND#. Proposed Funding Source: The study is internally funded. Communication of Study Results: The communication of study results will occur only between authorized individuals who are listed to take part in the study through our department. The individuals who will take part in the study will acknowledge and adhere to the importance of patient safety and the protection of their private information. The results of this study will be analyzed and published after the approval of the principal investigator, co-investigators, and biostatistician in a peer-reviewed scientific journal and/or presented at an international/national scientific conference or meeting regardless of outcome.

Arteriovenous graft, Propaten, Heparin-bonded, hemodialysis vascular access, Surgical, Arteriovenous Shunt

Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.

Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.

Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.

Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.

Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.

Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.

Will be based on the difference between total cost analysed on the basis of the specific graft price, cost of re-intervention procedures if any, treatment of complications, hospital stay, etc., and compared for each study arm.

Inclusion Criteria: Aged ≥18 years of all ethnicities End-stage Renal Disease stage 4 (GFR 15-29 ml/min 1.73m2) or stage 5 (GFR <15ml/min 1.73m2) per National Kidney Foundation guidelines Currently undergoing hemodialysis with a failure of previous access Expected to undergo hemodialysis within 6 months of presentation Exclusion Criteria: Unable/refuse to abide with follow-up Known hypercoagulability syndrome or a bleeding disorder On a previous anticoagulant treatment Intraoperative decision in favor of fistula instead of graft Pregnant or breast-feeding women A documented history of heparin induced thrombocytopenia or allergy Active infections Evidence or suspicion of central vein stenosis

University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston

University of Arkansas for Medical Sciences (UAMS) & Central Arkansas Veterans Healthcare System (CAVHS)

Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center

Charlton-Ouw KM, Nosrati N, Miller CC 3rd, Coogan SM, Safi HJ, Azizzadeh A. Outcomes of arteriovenous fistulae compared with heparin-bonded and conventional grafts for hemodialysis access. J Vasc Access. 2012 Apr-Jun;13(2):163-7. doi: 10.5301/JVA.2011.8715.