Application of Human Type I Pancreatic Elastase (PRT-201) to the venous Anastomosis of Arteriovenous Grafts in Patients with Chronic Kidney Disease

Purpose To explore the safety and efficacy of PRT-201 applied to the outflow vein of a newly created arteriovenous graft (AVG). Methods Randomized, double-blind, placebo-controlled, single-dose escalation study of PRT-201 (0.01 to 9 mg) applied to the graft-vein anastomosis and adjacent outflow vein...

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Bibliographic Details
Published in:The journal of vascular access 2014-09, Vol.15 (5), p.376-384
Main Authors: Dwivedi, Amit J., Roy-Chaudhury, Prabir, Peden, Eric K., Browne, Barry J., Ladenheim, Eric D., Scavo, Vincent A., Gustafson, Pamela N., Wong, Marco D., Magill, Marianne, Lindow, Francesca, Blair, Andrew T., Jaff, Michael R., Franano, F. Nicholas, Burke, Steven K.
Format: Article
Language:English
Subjects:
Adult
Aged
Arteriovenous Shunt, Surgical - adverse effects
Blood Flow Velocity
Carrier Proteins - administration & dosage
Carrier Proteins - adverse effects
Double-Blind Method
Female
Graft Occlusion, Vascular - diagnosis
Graft Occlusion, Vascular - etiology
Graft Occlusion, Vascular - physiopathology
Graft Occlusion, Vascular - prevention & control
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Original
Pancreatic Elastase - administration & dosage
Pancreatic Elastase - adverse effects
Regional Blood Flow
Renal Dialysis
Renal Insufficiency, Chronic - diagnosis
Renal Insufficiency, Chronic - therapy
Time Factors
Treatment Outcome
United States
Upper Extremity - blood supply
Vascular Patency
Veins - drug effects
Veins - physiopathology
Veins - surgery
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Summary:Purpose To explore the safety and efficacy of PRT-201 applied to the outflow vein of a newly created arteriovenous graft (AVG). Methods Randomized, double-blind, placebo-controlled, single-dose escalation study of PRT-201 (0.01 to 9 mg) applied to the graft-vein anastomosis and adjacent outflow vein immediately after AVG placement. The primary outcome measure was safety. The efficacy measures were intraoperative increases in outflow vein diameter and blood flow rate, primary unassisted patency, and secondary patency by dose groups (placebo, low, medium, high and All PRT-201). Results A total of 89 patients were treated (28 placebo and 61 PRT-201). There were no significant differences in the proportion of placebo and PRT-201 patients reporting adverse events. Intraoperative outflow vein diameter increased 5% (p=0.14) in the placebo group compared with 13% (p=0.01), 15% (p=0.07) and 12% (p
ISSN:1129-7298
1724-6032
DOI:10.5301/jva.5000235