Randomized Fistula Study

This study has been terminated.
(Slow enrollment due to multiple screen failures)
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
First received: December 12, 2008
Last updated: February 11, 2010
Last verified: February 2010

The primary objective of this study is to compare two treatment strategies for establishing dialysis access in patients with unsuitable forearm veins for the standard forearm primary radio-cephalic arteriovenous fistula also known as the Brescia-Cimino fistula.

Condition Intervention
Renal Failure
Other: Group 1: Alternative Fistula
Other: Group 2: Forearm AV Graft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Fistula vs. Forearm AV Graft in Patients With Poor Venous Access; Protocol #3, Version 1

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The primary endpoint will be the rate of composite adverse events at one year with follow-up to 3 years. Data will be tabulated every 6 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary endpoints: Primary, assisted primary, and secondary patency at 1 and 3 years [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death due to access-related illness [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death due to any cause [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
  • New central venous stenosis or occlusion [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Steal syndrome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Neuropathy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: December 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Alternative Fistula Other: Group 1: Alternative Fistula
Performing other autogenous AV fistulas which include various options such as brachiocephalic AV fistula, basilic or brachial vein transpositions or a variety of other strategies to maintain a primary access. The advantage would be to maintain an autogenous all venous access with less risk of infection and thrombosis.
Active Comparator: 2 Forearm AV Graft Other: Group 2: Forearm AV Graft
a) ePTFE (polytetrafluoroethylene) bridge AV graft typically anastomosed in the proximal forearm to the radial or brachial artery and to an antecubital vein. The advantages include a quick maturation of 2-3 weeks, excellent flow rates and high technical success rates. Although secondary patency rates approach 80% at one year postoperatively, disadvantages include a more involved surgical procedure, a lower primary patency than a well functioning AV fistula, and higher revision and infection rates.4, 5

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

To participate in this study, the subject MUST have all of the following for inclusion in the study:

  • The subject must be > 18 years of age, male or female
  • Subject requires creation of dialysis access secondary to ESRD in the opinion of the referring nephrologist
  • Target arm may have a failed radiocephalic fistula
  • Contralateral failed or failing access may exist
  • The subject must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.

Exclusion Criteria:

To participate in this study, the subject may NOT HAVE any of the following at enrollment to the study:

  • Target arm has existing forearm AV graft, either functional or non-functional
  • Target arm has existing fistula, either functional or non-functional, other than a radio-cephalic at the wrist
  • Target arm has documented subclavian vein occlusion
  • Target arm has obviously suitable cephalic vein and radial artery for a primary radiocephalic fistula
  • Target arm has no superficial veins existing as options for primary access. If so, a second surgeon will review the ultrasound to confirm
  • Active local or systemic infection at the time of surgery
  • Known hypercoagulable state (e.g., antithrombin III deficiency, antiphospholipid or anticardiolipin antibodies, Factor IV Leiden, circulating lupus anticoagulant, history of heparin-induced thrombocytopenia, Protein C or S deficiency, prothrombin mutation or a history of recurrent deep venous thrombosis and/or pulmonary embolism)
  • Disseminated malignancy or other terminal condition where subject is expected to live less than 6 months.
  • Previous randomization in this trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808561

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Navyash Gupta, MD University of Pittsburgh Physicians
  More Information

No publications provided

Responsible Party: Navyash Gupta, MD, University of Pittsburgh Physicians
ClinicalTrials.gov Identifier: NCT00808561     History of Changes
Other Study ID Numbers: Protocol #3, V1, Fistula
Study First Received: December 12, 2008
Last Updated: February 11, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014