Propaten Randomized Investigation on Cost-benefit and Efficacy (PRICE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01601873|
Recruitment Status : Terminated (Results from futility analysis conducted at planned interim time-point did not meet the study criteria for continuation.)
First Posted : May 18, 2012
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|End-stage Renal Disease||Device: PROPATEN Device: Standard Graft||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Heparin-bonded Versus Non-heparin-bonded Polytetrafluroethylene Hemodialysis Access Grafts.|
|Actual Study Start Date :||November 9, 2012|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||June 30, 2018|
patients with heparin-bonded graft implantation
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: Standard Graft
non-heparin bonded conventional hemodialysis vascular access graft
Other Name: Conventional ePTFE hemodialysis graft
- Primary Graft Patency Rate [ Time Frame: 12 months ]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 [ Time Frame: 12 months ]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 [ Time Frame: 12 months ]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.
- Primary Graft Patency Rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Number of Participants With Complications or Morbidity Attributable to the Study [ Time Frame: at least 1 year but up to two years ]Complication/morbidity associated with both types of interventions
- 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 (QoL) Comparison [ Time Frame: 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 [ Time Frame: at least 1 year but up to two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601873
|United States, Arkansas|
|University of Arkansas for Medical Sciences (UAMS) & Central Arkansas Veterans Healthcare System (CAVHS)|
|Little Rock, Arkansas, United States, 72205|
|United States, Louisiana|
|John Ochsner Heart & Vascular Institute Ochsner Medical Center|
|New Orleans, Louisiana, United States, 70121|
|United States, Ohio|
|University Hospitals Cleveland Medical Center|
|Cleveland, Ohio, United States, 44106|
|United States, Texas|
|Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center|
|Houston, Texas, United States, 77030|
|Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast|
|Houston, Texas, United States, 77089|
|Principal Investigator:||Kristofer M Charlton-Ouw, MD||University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston|