Propaten Randomized Investigation on Cost-benefit and Efficacy

End-stage Renal Disease Clinical Trial

— PRICE  

Official title:

A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Heparin-bonded Versus Non-heparin-bonded Polytetrafluroethylene Hemodialysis Access Grafts.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01601873
• Other study ID #: CTVS-KC01
• Secondary ID: UTHSCMS-12/0095
• Status: Terminated
• Phase: N/A
• Start date: November 9, 2012
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2019
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 103
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• PROPATEN
Heparin-bonded graft implantation for hemodialysis vascular access
• Standard Graft
non-heparin bonded conventional hemodialysis vascular access graft

Locations

Country	Name	City	State
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	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

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Ochsner Health System, University Hospitals Cleveland Medical Center, University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Graft Patency Rate	Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.	12 months
Primary	Primary-Assisted Graft Patency Rate	Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.	12 months
Primary	Secondary Graft Patency Rate	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.	12 months
Primary	Primary Graft Patency Rate	Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.	24 months after graft placement
Primary	Primary-Assisted Graft Patency Rate	Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.	24 months after graft placement
Primary	Secondary Graft Patency Rate	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.	24 months after graft placement
Secondary	Number of Participants With Complications or Morbidity Attributable to the Study	Complication/morbidity associated with both types of interventions	at least 1 year but up to two years
Secondary	Cost Estimation and Analysis	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.	During the study period based on an average participant follow-up of 2 years after graft placement
Secondary	Quality of Life (QoL) Comparison	Comparative assessment of quality of life reported by the patients in two arms	Participants would be followed for a period of 2 years after graft placement
Secondary	Number of Postoperative Re-interventions		at least 1 year but up to two years