Randomized Fistula Study

NCT00808561 | Terminated DMC

• 1 other identifier: Protocol #3, V1, Fistula
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (6)

• Secondary endpoints: Primary, assisted primary, and secondary patency at 1 and 3 years

  3 years

• Death due to access-related illness

  3 years

• Death due to any cause

  3 Years

• New central venous stenosis or occlusion

  3 years

• Steal syndrome

  3 years

Study Arms (2)

1 Alternative Fistula

ACTIVE COMPARATOR

Other: Group 1: Alternative Fistula

2 Forearm AV Graft

ACTIVE COMPARATOR

Other: Group 2: Forearm AV Graft

Interventions

Group 1: Alternative Fistula OTHER

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.

1 Alternative Fistula

Group 2: Forearm AV Graft OTHER

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

2 Forearm AV Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Navyash Gupta, MD

  University of Pittsburgh Physicians

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 16, 2008
• Study Start: December 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2013
• Last Updated: March 11, 2016

Record last verified: 2016-03

Locations

US (1)