Status:
TERMINATED
Randomized Fistula Study
Lead Sponsor:
University of Pittsburgh
Conditions:
Renal Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 ar...
Detailed Description
BACKGROUND AND SIGNIFICANCE: Among patients with end stage renal disease (ESRD) who require hemodialysis, the maintenance of an adequate vascular access is of critical importance. As the overall popu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00808561
Start Date
December 1 2008
End Date
January 1 2013
Last Update
March 11 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232