Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5%

PHASE3TerminatedINTERVENTIONAL
Enrollment

275

Participants

Timeline

Start Date

February 21, 2019

Primary Completion Date

April 14, 2025

Study Completion Date

April 14, 2025

Conditions
Acute-On-Chronic Liver Failure
Interventions
BIOLOGICAL

SMT + PE-A 5%

Plasma exchange treatment (PE-A 5%) will be performed using 5% albumin solution (Albutein 5%). Fresh frozen plasma will be given to prevent coagulopathy. IVIGs will be administered intravenously to prevent the development of hypogammaglobulinemia and infection.

OTHER

Standard Medical Treatment

Standard medical treatment according to the institution's standard practice

Trial Locations (40)

161

Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma

1070

Université libre de Bruxelles, Brussels

3000

UZ Leuven - Campus Gasthuisberg, Leuven

4103

Universitaetsklinikum Leipzig, Leipzig

15213

University of Pittsburgh Medical Center, Pittsburgh

19104

University of Pennsylvania, Philadelphia

20122

Milano Hospital Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

23249

McGuire VA Medical Center, Richmond

24127

ASST Papa Giovanni XXIII, Bergamo

28007

Hospital General Gregorio Marañón, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

30322

Emory University, Atlanta

30625

Hannover Medical School, Hanover

35128

Azienda Ospedaliera di Padova, Padua

35294

University of Alabama at Birmingham (UAB) Hospital, Birmingham

43210

Ohio State University Wexner Medical Center, Columbus

53105

Universitätsklinikum Bonn, Bonn

53215

Aurora Health Care, Inc., Milwaukee

55905

Mayo Clinic Rochester, Rochester

60590

Universitätsklinikum Frankfurt, Frankfurt

66045

University of Kansas, Kansas City

81377

Klinikum der Universitaet Muenchen, München

85054

Mayo Clinic Phoenix, Phoenix

87131

University of New Mexico, Albuquerque

90048

Cedars-Sinai Medical Center, Los Angeles

92110

Hôpital Beaujon, Clichy

92118

Southern California Research Center, Coronado

94804

Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse, Villejuif

98195

University of Washington Medical Center, Seattle

07101

Rutgers-New Jersey Medical School, Newark

A-1090

Medical University of Vienna, Vienna

Unknown

Rigshospitalet, Copenhagen

Centro Hospitalar do Porto, Porto

1649-028

Centro Hospitalar Lisboa Norte, Lisbon

08035

Hospital Universitario del Valle Hebron, Barcelona

08036

Hospital Clínic de Barcelona, Barcelona

NW3 2QG

Royal Free NHS Foundation Trust Hospital, London

SE5 9RS

King's College Hospital NHS Foundation Trust, London

NG72UH

Nottingham University Hospital, Nottingham

Sponsors
All Listed Sponsors
collaborator

Instituto Grifols, S.A.

INDUSTRY

lead

Grifols Therapeutics LLC

INDUSTRY