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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborator:
Case Western Reserve University
Information provided by (Responsible Party):
Kristofer Charlton-Ouw, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01601873
First received: May 16, 2012
Last updated: December 4, 2013
Last verified: December 2013

May 16, 2012
December 4, 2013
November 2012
December 2015   (final data collection date for primary outcome measure)
Graft Patency Rates [ Time Frame: Participants would be followed for a period of 2 years after graft placement ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01601873 on ClinicalTrials.gov Archive Site
  • Complication or morbidity rates comparing both types of interventions [ Time Frame: Participants would be followed for a period of 2 years after graft placement ] [ Designated as safety issue: Yes ]
  • Cost estimation and analysis [ Time Frame: During the study period based on an average participant follow-up of 2 years after graft placement ] [ Designated as safety issue: No ]
    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.
  • Quality of life comparison [ Time Frame: Participants would be followed for a period of 2 years after graft placement ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Propaten Randomized Investigation on Cost-benefit and Efficacy
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 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
End-stage Renal Disease
  • Device: Heparin-bonded vascular access graft
    Heparin-bonded graft implantation for hemodialysis vascular access
    Other Name: Heparin-bonded hemodialysis graft
  • Device: Conventional ePTFE hemodialysis graft
    non-heparin bonded conventional hemodialysis vascular access graft
    Other Name: Standard ePTFE graft
  • Experimental: PROPATEN
    patients with heparin-bonded graft implantation
    Intervention: Device: Heparin-bonded vascular access graft
  • Active Comparator: Standard Graft
    patients undergoing ePTFE hemodialysis graft implantation
    Intervention: Device: Conventional ePTFE hemodialysis graft
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2018
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kristofer M Charlton-Ouw, MD 713-486-5100 Kristofer.CharltonOuw@uth.tmc.edu
Contact: Harleen K Sandhu, MD 713-486-5100 Harleen.K.Sandhu@uth.tmc.edu
United States
 
NCT01601873
CTVS-KC01, UTHSCMS-12/0095
Yes
Kristofer Charlton-Ouw, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Case Western Reserve University
Principal Investigator: Kristofer M Charlton-Ouw, MD University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston
The University of Texas Health Science Center, Houston
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP