title: Fibrinogen is not a prognostic factor for response to HELP-apheresis in sudden sensorineural hearing loss (SSHL).
abstract: Higher levels of fibrinogen or cholesterol were associated with improved hearing recovery in SSHL patients after treatment with HELP-apheresis (Heparin-induced extracorporeal LDL precipitation apheresis). The present trial was performed to demonstrate HELP-related effects on relevant metabolic and inflammatory parameters in the context of SSHL treatment. In the framework of a single arm non-controlled trial, we investigated the variation of metabolic and inflammatory parameters using HELP-apheresis for a defined group of 100 patients with SSHL. Based on cut off inclusion criteria (Serum LDL-cholesterol >1.6 g/l and/or fibrinogen >2.0 g/l, SSHL in minimum three frequencies more than 30 dB, time after event not longer than 6 days), the protocol followed a strict time line with one single shot HELP-apheresis and follow-up monitoring including laboratory parameters at six defined time points. If HELP-apheresis could not effect improvement of hearing on day 5, additional corticosteroid treatment was applied. Concentration of anti-inflammatory IL-10 increased while other proinflammatory parameters declined. Serum levels of all measured sterols and apolipoproteins decreased significantly. None of the investigated parameters were suitable to predict hearing improvement of the patients. Levels of fibrinogen and LDL-cholesterol were not prognostic for outcome after HELP-apheresis. A significant (p < 0.001) increase of anti-inflammatory IL-10 after apheresis was notable, while most of the proinflammatory parameters declined. Despite the limited validity of a single arm non-controlled trial, these alterations on immune modulating factors indicate possible secondary pleiotropic effects caused by HELP-apheresis.
authors.affiliation: Department of Head Medicine and Oral Health, ENT-Department, University Hospital Leipzig, Liebigstr. 10-14, 04103, Leipzig, Germany. thomas.berger@medizin.uni-leipzig.de.
authors.forename: T
authors.initials: T
authors.lastname: Berger
authors.affiliation: Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University Hospital, Leipzig, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Kaiser
authors.affiliation: Institute for Medical Informatics, Statistics and Epidemiology (IMISE), University Hospital Leipzig, Leipzig, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Scholz
authors.affiliation: Department of Internal Medicine Neurology and Dermatology, Division of Nephrology, University Hospital Leipzig, Leipzig, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Bachmann
authors.affiliation: Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University Hospital, Leipzig, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Ceglarek
authors.affiliation: Ear- and Hearing Institute Tinnitus-clinic Dr. Hesse, Witten/Herdecke University, Bad Arolsen, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Hesse
authors.affiliation: Department of Head Medicine and Oral Health, ENT-Department, University Hospital Leipzig, Liebigstr. 10-14, 04103, Leipzig, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Hagemeyer
authors.affiliation: Department of Internal Medicine Neurology and Dermatology, Division of Nephrology, University Hospital Leipzig, Leipzig, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Stumvoll
authors.affiliation: Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University Hospital, Leipzig, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Thiery
authors.affiliation: Department of Head Medicine and Oral Health, ENT-Department, University Hospital Leipzig, Liebigstr. 10-14, 04103, Leipzig, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Dietz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D001781:Blood Component Removal / Q000379:methods*; D008078:Cholesterol, LDL / Q000097:blood; D005112:Extracorporeal Circulation; D005260:Female; D005340:Fibrinogen / Q000032:analysis*; D006319:Hearing Loss, Sensorineural / Q000628:therapy*; D003639:Hearing Loss, Sudden / Q000628:therapy*; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D016753:Interleukin-10 / Q000097:blood; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D008078:Cholesterol, LDL; D016753:Interleukin-10; D005340:Fibrinogen; D006493:Heparin
keywords: Fibrinogen; HELP-apheresis; Inflammatory parameters; LDL-Cholesterol; Sudden sensorineural hearing loss