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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01601873
Recruitment Status : Active, not recruiting
First Posted : May 18, 2012
Last Update Posted : November 21, 2017
University Hospitals Cleveland Medical Center
University of Arkansas
Ochsner Health System
Information provided by (Responsible Party):
Kristofer Charlton-Ouw, The University of Texas Health Science Center, Houston

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Device: PROPATEN Device: Standard Graft Not Applicable

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  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Heparin-bonded Versus Non-heparin-bonded Polytetrafluroethylene Hemodialysis Access Grafts.
Actual Study Start Date : November 9, 2012
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PROPATEN
patients with heparin-bonded graft implantation
Heparin-bonded graft implantation for hemodialysis vascular access
Other Name: 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 Name: Conventional ePTFE hemodialysis graft

Primary Outcome Measures :
  1. Graft Patency Rates [ Time Frame: Participants would be followed for a period of 2 years after graft placement ]
    The primary graft patency, along with primary-assisted and secondary patency rates would be measured based on an average follow-up of patients for 2 years during the course of the study.

Secondary Outcome Measures :
  1. Complication or morbidity [ Time Frame: Participants would be followed for a period of 2 years after graft placement ]
    Complication/morbidity rates and need for reintervention comparing both types of interventions

  2. Cost estimation and analysis [ Time Frame: During the study period based on an average participant follow-up of 2 years after graft placement ]
    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.

  3. Quality of life comparison [ Time Frame: Participants would be followed for a period of 2 years after graft placement ]
    Comparative assessment of quality of life reported by the patients in two arms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01601873

United States, Arkansas
University of Arkansas for Medical Sciences (UAMS) & Central Arkansas Veterans Healthcare System (CAVHS)
Little Rock, Arkansas, United States, 72205
United States, Louisiana
John Ochsner Heart & Vascular Institute Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Texas
Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
Houston, Texas, United States, 77030
Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast
Houston, Texas, United States, 77089
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
University Hospitals Cleveland Medical Center
University of Arkansas
Ochsner Health System
Principal Investigator: Kristofer M Charlton-Ouw, MD University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston

Responsible Party: Kristofer Charlton-Ouw, Associate Professor, Department of Cardiothoracic and Vascular Surgery, The University of Texas Health Science Center, Houston Identifier: NCT01601873     History of Changes
Other Study ID Numbers: CTVS-KC01
UTHSCMS-12/0095 ( Other Identifier: UTHSC IRB )
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified data will be available following institutional review board approval

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Kristofer Charlton-Ouw, The University of Texas Health Science Center, Houston:
Arteriovenous graft
hemodialysis vascular access
Arteriovenous Shunt

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action