Original ResearchClinical—LiverEffects of Fractionated Plasma Separation and Adsorption on Survival in Patients With Acute-on-Chronic Liver Failure
Section snippets
Patients
All patients hospitalized between June 2005 and January 2008 due to severe deterioration of chronic liver disease with serum bilirubin level of ≥5 mg/dL and Child–Pugh score of ≥10 were screened for participation in the study. Only patients who were judged by the attending physician to have an acute deterioration of previously stable chronic liver failure were eligible for participation if they did not fulfill any exclusion criterion. Patients with severe comorbidity that could affect survival
Study Population
A total of 145 patients with AOCLF were included in the study. The disposition of all patients included is shown in Supplementary Figure 1. All patients were included in the ITT analysis independently of whether they received the allocated therapy or not. Five of the 77 patients randomized to the FPSA group did not receive FPSA therapy within the first 4 days after randomization for various reasons (Supplementary Figure 1). These patients were not evaluated in the PP analysis. Other patients
Discussion
AOCLF occurs frequently in patients with chronic liver disease. Because there are still no effective therapies available, it is associated with a poor prognosis.2 Here we report the largest therapeutic trial performed in patients with AOCLF evaluating the effects of an extracorporeal liver support system based on FPSA on survival. The results of our study show that the use of FPSA together with SMT in patients with AOCLF does not significantly improve overall survival probability compared with
Acknowledgments
A list of the investigators of the HELIOS Study Group appears in the Appendix.
The authors thank Julia Wendon and Frieder Berr for assistance with the preparation of the study protocol, AMS Advanced Medical Services GmbH (Mannheim, Germany) for data management and statistical analysis, and Daniel Abeles for editing support.
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Conflicts of interest These authors disclose the following: S. Herget-Rosenthal has received honoraries for lectures from Fresenius Medical Care. U. Treichel has received a consultancy fee from Fresenius Medical Care. H. Salmhofer has received an honorary for a lecture from Amgen and Fresenius Medical Care Workshop. J. Kozik-Jaromin is an employee of Fresenius Medical Care. All participating institutions received reimbursement for the conduct of the study. The remaining authors disclose no conflicts.
Funding Conduct of the study was supported by Fresenius Medical Care.