Propaten Randomized Investigation on Cost-benefit and Efficacy

NCT ID: NCT01601873

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-09
• Study Completion Date: 2018-06-30

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.

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.

Conditions

End-stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PROPATEN

patients with heparin-bonded graft implantation

Group Type: EXPERIMENTAL

PROPATEN

Intervention Type: DEVICE

Heparin-bonded graft implantation for hemodialysis vascular access

Standard Graft

patients undergoing ePTFE hemodialysis graft implantation

Group Type: ACTIVE_COMPARATOR

Standard Graft

Intervention Type: DEVICE

non-heparin bonded conventional hemodialysis vascular access graft

Interventions

PROPATEN

Heparin-bonded graft implantation for hemodialysis vascular access

Intervention Type: DEVICE

Standard Graft

non-heparin bonded conventional hemodialysis vascular access graft

Intervention Type: DEVICE

Other Intervention Names

Heparin-bonded hemodialysis graft; Conventional ePTFE hemodialysis graft

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: collaborator

Ochsner Health System

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Kristofer Charlton-Ouw

Associate Professor, Department of Cardiothoracic and Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristofer M Charlton-Ouw, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston

Locations

University of Arkansas for Medical Sciences (UAMS) & Central Arkansas Veterans Healthcare System (CAVHS)

Little Rock, Arkansas, United States

John Ochsner Heart & Vascular Institute Ochsner Medical Center

New Orleans, Louisiana, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center

Houston, Texas, United States

Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21983827 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UTHSCMS-12/0095

Identifier Type: OTHER

Identifier Source: secondary_id

CTVS-KC01

Identifier Type: -

Identifier Source: org_study_id