Propaten Randomized Investigation on Cost-benefit and Efficacy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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End-stage Renal Disease

Intervention / Treatment
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* Device: PROPATEN
* Device: Standard Graft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PROPATEN<br>patients with heparin-bonded graft implantation | Device: PROPATEN<br>* Heparin-bonded graft implantation for hemodialysis vascular access<br>* Other names: Heparin-bonded hemodialysis graft;|
| Active Comparator: Standard Graft<br>patients undergoing ePTFE hemodialysis graft implantation | Device: Standard Graft<br>* non-heparin bonded conventional hemodialysis vascular access graft<br>* Other names: Conventional ePTFE hemodialysis graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Graft Patency Rate | Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention. | 12 months | 
| Primary-Assisted Graft Patency Rate | Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention. | 12 months | 
| Secondary Graft Patency Rate | 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. | 12 months | 
| Primary Graft Patency Rate | Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention. | 24 months after graft placement | 
| Primary-Assisted Graft Patency Rate | Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention. | 24 months after graft placement | 
| Secondary Graft Patency Rate | 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. | 24 months after graft placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complications or Morbidity Attributable to the Study | Complication/morbidity associated with both types of interventions | at least 1 year but up to two years | 
| Cost Estimation and Analysis | 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. | During the study period based on an average participant follow-up of 2 years after graft placement | 
| Quality of Life (QoL) Comparison | Comparative assessment of quality of life reported by the patients in two arms | Participants would be followed for a period of 2 years after graft placement | 
| Number of Postoperative Re-interventions |  | at least 1 year but up to two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arteriovenous graft, Propaten, Heparin-bonded, hemodialysis vascular access, Surgical, Arteriovenous Shunt