Condition category
Digestive System
Date applied
17/01/2006
Date assigned
23/02/2006
Last edited
30/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rafael Bañares

ORCID ID

Contact details

Hospital General Universitario
Servicio de Gastroenterología (Sección de Hepatología)
C/ Dr Esquerdo
46
Madrid
28007
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00614146

Protocol/serial number

1438

Study information

Scientific title

Recompensation of Exacerbated Liver Insufficiency with hyperbilirubinaemia and/or Encephalopathy and/or renal Failure

Acronym

RELIEF

Study hypothesis

Patients with Molecular Adsorbents Recirculation System (MARS®) treatments in addition to standard medical treatment show a significant improvement in 28-day transplant-free survival.

On 10/12/2007 the overall trial end date was changed from 01/08/2007 to 01/09/2008.

Ethics approval

Ethics approval received from the Freiburg Ethics Commission International (first review) on the 02/04/2003. Local Ethics Committee approval sought for every study site.

Study design

Randomised prospective open controlled non-blinded two-armed study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Recent clinical severe decompensation of a presumed cirrhosis related to a precipitating event

Intervention

Comparison of standard medical treatment (SMT) for acute-on-chronic liver failure versus MARS® liver support therapy in addition to SMT.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

28-day transplant-free survival

Secondary outcome measures

1. 28-day survival regardless of transplantation
2. 84-day survival
3. In-hospital mortality
4. Time course of clinical state (number and severity of complications, vital signs, scoring systems, laboratory tests)
5. Economic analysis

Overall trial start date

16/04/2003

Overall trial end date

01/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Signed written informed consent by patient or next of kin
2. Age greater than 18 years
3. Patients with a recent clinical severe decompensation of a presumed cirrhosis (based on clinical evaluation or radiological imaging) related to a precipitating (trigger) event (e.g. infection, bleeding, alcohol abuse)
4. Intrahepatic cholestasis (bilirubin greater than 5 mg/dl or greater than 85 µmol/l, respectively) without evidence of extrahepatic origin and at least one of the following three:
4.1. Hepatorenal syndrome (impaired renal function with creatinine greater than 1.5 mg/dl or greater than 133 µmol/l without evidence of reduced vascular volume [e.g. central venous pressure {CVP} greater than 8 cm H2O] and no evidence of pre-existing renal failure)
4.2. Hepatic Encephalopathy greater than or equal to II°
4.3. Progressive Hyperbilirubinaemia: defined as a more than 50% increase of bilirubin before enrolment, whether in referral or currently in hospital up to a level of greater than 20 mg/dl (or greater than 340 µmol/l)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

172

Participant exclusion criteria

1. Progressive jaundice and deterioration as a natural course of a chronic liver disease without precipitating (trigger) event
2. Severe thrombocytopenia (platelet count less than or equal to 50 glutamic pyruvic transaminase [GPT]/l)
3. Severe coagulopathy (international normalised ratio [INR] greater than 2.3)
4. Need for renal replacement therapy within three days prior to enrolment
5. Severe infection without antibiotic treatment for at least 24 hours. Uncontrolled bacterial infection.
6. Active bleeding within 48 hours prior to enrolment
7. Proven hepatocellular carcinoma (HCC) greater than 4 cm or infiltration of portal vein or acute portal vein thrombosis
8. Severe cardiopulmonary disease (New York Heart Association [NYHA] greater than or equal to 2)
9. Pregnancy/lactation
10. Mean arterial pressure (MAP) less than 60 mmHg despite vasopressor agents (norepinephrine greater than 1 µg/kg/min) for blood pressure support
11. Overt clinical evidence for disseminated intravascular coagulation (DIC)
12. Clinical evidence for coma of non-hepatic origin
13. Extra-hepatic cholestasis
14. Severe intrinsic renal disease
15. Extended surgical procedure within the last four weeks or unsolved surgical problems
16. Known human immunodeficiency virus (HIV) infection

Recruitment start date

16/04/2003

Recruitment end date

01/09/2008

Locations

Countries of recruitment

Austria, Belgium, Denmark, France, Germany, Italy, Spain, Switzerland, United Kingdom

Trial participating centre

Hospital General Universitario
Madrid
28007
Spain

Sponsor information

Organisation

Gambro Lundia AB (Sweden)

Sponsor details

Study Director Ludger Thiele
P.O. Box 1010
Magistratsvägen 16
Lund
22010
Sweden
+33 (0)437281135
ludger.thiele@gambro.com

Sponsor type

Industry

Website

http://www.gambro.com

Funders

Funder type

Industry

Funder name

Gambro Lundia AB (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes