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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
Sponsor:
Collaborators:
University Hospitals Cleveland Medical Center
University of Arkansas
Ochsner Health System
Information provided by (Responsible Party):
Kristofer Charlton-Ouw, 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.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Device: PROPATEN Device: Standard Graft Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
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.
Actual Study Start Date : November 9, 2012
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PROPATEN
patients with heparin-bonded graft implantation
Device: PROPATEN
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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. Number of Postoperative Re-interventions [ Time Frame: at least 1 year but up to two years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
University Hospitals Cleveland Medical Center
University of Arkansas
Ochsner Health System
Investigators
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Principal Investigator: Kristofer M Charlton-Ouw, MD University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston
  Study Documents (Full-Text)

Documents provided by Kristofer Charlton-Ouw, The University of Texas Health Science Center, Houston:
Publications:
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Responsible Party: Kristofer Charlton-Ouw, Associate Professor, Department of Cardiothoracic and Vascular Surgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01601873    
Other Study ID Numbers: CTVS-KC01
UTHSCMS-12/0095 ( Other Identifier: UTHSC IRB )
First Posted: May 18, 2012    Key Record Dates
Results First Posted: February 27, 2019
Last Update Posted: February 27, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified data will be available following institutional review board approval

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kristofer Charlton-Ouw, The University of Texas Health Science Center, Houston:
Arteriovenous graft
Propaten
Heparin-bonded
hemodialysis vascular access
Surgical
Arteriovenous Shunt
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action