Propaten Randomized Investigation on Cost-benefit and Efficacy (PRICE)
|End-stage Renal Disease||Device: Heparin-bonded vascular access graft Device: Conventional ePTFE hemodialysis graft||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
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.|
- Graft Patency Rates [ Time Frame: Participants would be followed for a period of 2 years after graft placement ]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.
- Complication or morbidity rates comparing both types of interventions [ Time Frame: Participants would be followed for a period of 2 years after graft placement ]
- Cost estimation and analysis [ Time Frame: 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 comparison [ Time Frame: Participants would be followed for a period of 2 years after graft placement ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601873
|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, Arkansas|
|University of Arkansas for Medical Sciences (UAMS) & Central Arkansas Veterans Healthcare System (CAVHS)||Recruiting|
|Little Rock, Arkansas, United States, 72205|
|Contact: Matthew R Smeds, MD 501-686-6176|
|Contact: Sandra Brock, RN (501)-257-6906 BrockSandraJ@uams.edu|
|United States, Louisiana|
|John Ochsner Heart & Vascular Institute Ochsner Medical Center||Recruiting|
|New Orleans, Louisiana, United States, 70121|
|Contact: Taylor A Smith, MD 504-842-4053 firstname.lastname@example.org|
|Contact: Shannon Williams, RTR,CRC 504-842-6487 email@example.com|
|United States, Ohio|
|University Hospitals Cleveland Medical Center||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|
|Principal Investigator:||Kristofer M Charlton-Ouw, MD||University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston|