title: Hematologic and biochemical effects of the Gradiflow in an ex vivo ovine model.
abstract: The Gradiflow (Life Therapeutics, Frenchs Forest, Australia) system is a novel electrophoretic technique that uses the dual characteristics of size and charge to separate target macromolecules from complex biological solutions. The system has the potential to selectively remove a range of moieties from blood and plasma in an in vivo system such as hemodialysis or, alternatively, in an in vitro setting such as a blood bank. In this study, the safety of a scaled down Gradiflow prototype device with a membrane surface area of 16 cm2 was investigated using an ex vivo ovine model. Physiologic, hematologic, and biochemical parameters were assessed in 12 sheep: 6 animals treated using the Gradiflow and 6 controls. The effects of the Gradiflow procedure on both whole blood and plasma were analyzed. The Gradiflow procedure was well tolerated, and the application of an electrical potential or exposure to the Gradiflow membrane did not cause any significant changes in the parameters measured. Hemoglobin levels remained stable in all groups during the 4-hour experiment. An early neutropenia was observed in all groups, although this appeared to be more pronounced with exposure to a plasma filter; the presence of the Gradiflow component had no separate influence. One sheep in the plasma group experienced septic shock, caused by Staphylococcus contamination of the separation membrane. Overall, the results indicate that there were no gross physiologic, hematologic, or biochemical adverse reactions to the ex vivo Gradiflow procedure.
authors.affiliation: Department of Renal Medicine, The University of Sydney at Westmead Millennium Institute, Westmead, Australia.
authors.forename: Jason I
authors.initials: JI
authors.lastname: Lee
authors.forename: Anne
authors.initials: A
authors.lastname: Simmons
authors.forename: Ross O
authors.initials: RO
authors.lastname: Odell
authors.forename: Steven A
authors.initials: SA
authors.lastname: Botto
authors.forename: Ellie L
authors.initials: EL
authors.lastname: Faramus
authors.forename: Klaus
authors.initials: K
authors.lastname: Schindhelm
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Roeth
authors.forename: Hari C
authors.initials: HC
authors.lastname: Nair
authors.forename: David C H
authors.initials: DC
authors.lastname: Harris
mesh_terms: D000818:Animals; D001219:Aspartate Aminotransferases / Q000097:blood; D001663:Bilirubin / Q000097:blood; D001774:Blood Chemical Analysis; D001794:Blood Pressure; D001831:Body Temperature; D003402:Creatine Kinase / Q000097:blood; D004591:Electrophoresis, Polyacrylamide Gel / Q000295:instrumentation* / Q000662:veterinary*; D005112:Extracorporeal Circulation; D006339:Heart Rate; D006454:Hemoglobins / Q000032:analysis; D007958:Leukocyte Count; D010949:Plasma / Q000737:chemistry; D006435:Renal Dialysis / Q000295:instrumentation* / Q000662:veterinary*; D012119:Respiration; D012756:Sheep; D013997:Time Factors
chemical_list: D006454:Hemoglobins; D001219:Aspartate Aminotransferases; D003402:Creatine Kinase; D001663:Bilirubin