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
  Purpose

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 Intervention Phase
End-stage Renal Disease
Device: Heparin-bonded vascular access graft
Device: Conventional ePTFE hemodialysis graft
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PROPATEN
patients with heparin-bonded graft implantation
Device: Heparin-bonded vascular access graft
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: Conventional ePTFE hemodialysis graft
non-heparin bonded conventional hemodialysis vascular access graft
Other Name: Standard ePTFE 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601873

Contacts
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

Locations
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Virginia Wong, MD    216-844-3013      
Principal Investigator: Virginia Wong, MD         
United States, Texas
Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Kristofer M Charlton-Ouw, MD    713-486-5100    Kristofer.CharltonOuw@uth.tmc.edu   
Contact: Harleen K Sandhu, MD    713-486-5131    Harleen.K.Sandhu@uth.tmc.edu   
Principal Investigator: Kristofer M Charlton-Ouw, MD         
Sub-Investigator: Ali Azizzadeh, MD         
Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast Recruiting
Houston, Texas, United States, 77089
Contact: Gordon Martin, MD    713-486-1160      
Contact: Naveed Saqib, MD    713-486-1160      
Sub-Investigator: Gordon Martin, MD         
Sub-Investigator: Naveed Saqib, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Case Western Reserve University
Investigators
Principal Investigator: Kristofer M Charlton-Ouw, MD University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston
  More Information

Publications:
Responsible Party: Kristofer Charlton-Ouw, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01601873     History of Changes
Other Study ID Numbers: CTVS-KC01, UTHSCMS-12/0095
Study First Received: May 16, 2012
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Arteriovenous graft
Propaten
Heparin-bonded
hemodialysis vascular access
Surgical
Arteriovenous Shunt

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014