P-5 APACHE STUDY DESIGN TO EVALUATE THE EFFICACY AND SAFETY OF PLASMA EXCHANGE WITH HUMAN SERUM ALBUMIN 5% ON SHORT-TERM SURVIVAL IN PATIENTS WITH ACUTE-ON-CHRONIC LIVER FAILURE AT HIGH RISK OF HOSPITAL MORTALITY.
Nikolaos Pyrsopoulos1, Giovanni Perricone2, Jasmohan S. Bajaj3, Thierry Gustot4, Thomas Reiberger5, Mireia Torres6, Peter Nelson6, Javier Fernandez7, Apache Study Investigators 8
1 Division of Gastroenterology and Hepatology, Rutgers-New Jersey Medical School, New Jersey, Estados Unidos (EEUU)
2 Hepatology and Gastroenterology Unit, ASST GOM Niguarda, Milan, Italia
3 Division of Gastroenterology, Hepatology, and Nutrition, Richmond VA Medical Center and Virginia Commonwealth University, Richmond, Virginia, Estados Unidos (EEUU)
4 Department of Gastroenterology, Hepato-Pancreatology, HUB Erasme Hospital, Université Libre de Bruxelles, Brussels, Bélgica
5 Division of Gastroenterology and Hepatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria
6 Clinical Operations, Scientific Innovation Office, Grifols, Barcelona, España
7 Liver Unit, EF Clif, EASL-CLIF Consortium and Grifols Chair, Hospital Clínic, IDIBAPS and CIBERehd, Barcelona, España
8 Apache Study Investigators, Barcelona, España
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Liver transplantation is the only treatment to improve survival. A pilot study suggested that plasma exchange with human serum albumin 5% (PEA5%) as a replacement fluid is feasible and safe in ACLF patients and may improve organ function and survival. This study aimed to assess PE-A5% as a treatment for patients with ACLF in a pivotal study.</p></span> <span id="abss0002" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0002">Materials and Methods</span><p id="spara002" class="elsevierStyleSimplePara elsevierViewall">A phase 3, multicenter, randomized (1:1), controlled, parallel-group, open-label study (APACHE) compares standard medical treatment (SMT) + PE-A5% (treatment arm) to SMT alone (control arm). PE-A5% is performed using Albutein 5% (Grifols). Treatment schedule consists of two initial PE-A5% sessions on consecutive days followed by every other day PE-A5% (min-max 4-9 PE-A5%). Patients receive IVIG (200mg/kg) after every 2 PE-A5% to prevent hypogammaglobulinemia-associated infections, and FFP after each PE-A5% to prevent coagulopathy. Eligible patients are adult (18-79 years old), with ACLF-1b, ACLF-2, or ACLF-3a at admission or during hospitalization. Main exclusion criteria are patients with ACLF-1a or ACLF-3b, ACLF >10 days before randomization, septic shock requiring norepinephrine (>0.3µg/kg/min) or a second vasopressor, active infection, and severe respiratory failure.</p></span> <span id="abss0003" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0003">Results</span><p id="spara003" class="elsevierStyleSimplePara elsevierViewall">Target enrollment is 380 ACLF patients at high risk of hospital mortality. The primary efficacy endpoint is the 90-day overall survival. Secondary efficacy endpoints include 90-day transplant-free survival and 28-day overall survival. Main exploratory endpoints include overall and transplant-free survival at days 28 and 90, in-patient hospital and ICU stay, incidence of organ failures and ACLF course. Safety analyses include adverse events, vital signs, physical assessments, and laboratory tests.</p></span> <span id="abss0004" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0004">Conclusions</span><p id="spara004" class="elsevierStyleSimplePara elsevierViewall">APACHE will provide pivotal results on the efficacy and safety of PE-A5% as a treatment to improve survival in ACLF (NCT03702920;EudraCT:2016-001787-10).</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abss0001" "titulo" => "Introduction and Objectives" ] 1 => array:2 [ "identificador" => "abss0002" "titulo" => "Materials and Methods" ] 2 => array:2 [ "identificador" => "abss0003" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abss0004" "titulo" => "Conclusions" ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/16652681/00000029000000S1/v2_202405310451/S1665268123002958/v2_202405310451/en/main.assets" "Apartado" => null "PDF" => "https://static.elsevier.es/multimedia/16652681/00000029000000S1/v2_202405310451/S1665268123002958/v2_202405310451/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1665268123002958?idApp=UINPBA00004N" ]
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