Randomized Fistula Study

Stopped early · Not applicable

Conditions studied: Renal Failure

In brief

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.

Key facts

Study ID

NCT00808561

Run by

University of Pittsburgh

People needed

6

Starts

2008-12-01

Expected to finish

2013-01-01

Last updated by the study team

2016-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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