Clinical trial NCT01601873: Propaten Randomized Investigation on Cost-benefit and Efficacy
Official title: A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Heparin-bonded Versus Non-heparin-bonded Polytetrafluroethylene Hemodialysis Access Grafts.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End-stage Renal Disease
Keywords: Arteriovenous graft
Propaten
Heparin-bonded
hemodialysis vascular access
Surgical
Arteriovenous Shunt
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: University Hospitals Cleveland Medical Center
name: University of Arkansas
name: Ochsner Health System
First posted: 2012-05-18
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary Graft Patency Rate
timeFrame: 12 months
measure: Primary-Assisted Graft Patency Rate
timeFrame: 12 months
measure: Secondary Graft Patency Rate
timeFrame: 12 months
measure: Primary Graft Patency Rate
timeFrame: 24 months after graft placement
measure: Primary-Assisted Graft Patency Rate
timeFrame: 24 months after graft placement
measure: Secondary Graft Patency Rate
timeFrame: 24 months after graft placement
Secondary outcomes:
measure: Number of Participants With Complications or Morbidity Attributable to the Study
timeFrame: at least 1 year but up to two years
measure: Cost Estimation and Analysis
timeFrame: During the study period based on an average participant follow-up of 2 years after graft placement
measure: Quality of Life (QoL) Comparison
timeFrame: Participants would be followed for a period of 2 years after graft placement
measure: Number of Postoperative Re-interventions
timeFrame: at least 1 year but up to two years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences (UAMS) & Central Arkansas Veterans Healthcare System (CAVHS)
state: Arkansas
city: New Orleans
country: United States
facility: John Ochsner Heart & Vascular Institute Ochsner Medical Center
state: Louisiana
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Houston
country: United States
facility: Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
state: Texas
city: Houston
country: United States
facility: Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast
state: Texas
Study officials:
affiliation: University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston
name: Kristofer M Charlton-Ouw, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.