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.

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 Overview

• Status: Terminated
• Conditions: End-stage Renal Disease
• Intervention / Treatment: Device: PROPATEN; Device: Standard Graft

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences (UAMS) & Central Arkansas Veterans Healthcare System (CAVHS)
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • John Ochsner Heart & Vascular Institute Ochsner Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
    • Houston, Texas, United States, 77089
      • Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: University Hospitals Cleveland Medical Center; University of Arkansas; Ochsner Health System
• Investigators: Principal Investigator: Kristofer M Charlton-Ouw, MD, University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2012
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: May 16, 2012
• First Submitted That Met QC Criteria: May 16, 2012
• First Posted (Estimate): May 18, 2012

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Surgical; Arteriovenous graft; hemodialysis vascular access; Propaten; Heparin-bonded; Arteriovenous Shunt
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: CTVS-KC01; UTHSCMS-12/0095 (Other Identifier: UTHSC IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified data will be available following institutional review board approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No