Propaten Randomized Investigation on Cost-benefit and Efficacy

Not Applicable

Terminated

Conditions: End-stage Renal Disease

Interventions: Device: PROPATEN
Device: Standard Graft

Registration Number: NCT01601873

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 103

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PROPATEN	PROPATEN	patients with heparin-bonded graft implantation
Standard Graft	Standard Graft	patients undergoing ePTFE hemodialysis graft implantation

Primary Outcome Measures

Name	Time	Method
Primary Graft Patency Rate	24 months after graft placement	Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.
Primary-Assisted Graft Patency Rate	24 months after graft placement	Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.
Secondary Graft Patency Rate	24 months after graft placement	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Complications or Morbidity Attributable to the Study	at least 1 year but up to two years	Complication/morbidity associated with both types of interventions
Cost Estimation and Analysis	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.
Quality of Life (QoL) Comparison	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
Number of Postoperative Re-interventions	at least 1 year but up to two years

Trial Locations

Locations (5): 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; Memorial Hermann Hospital Southeast
🇺🇸
Houston, Texas, United States
Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
🇺🇸
Houston, Texas, United States
University of Arkansas for Medical Sciences (UAMS) & Central Arkansas Veterans Healthcare System (CAVHS)
🇺🇸
Little Rock, Arkansas, United States