Condition category
Digestive System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Blood purification can be done to help critical illnesses such as liver cancer as the liver is unable to remove toxins from the blood. It is similar to kidney dialysis, where the blood is pumped out of the body to be filtered by a machine and then pumped back to the body. However, when this is done it is usually requires an anticoagulation agent to prevent clotting. Research has developed a new algorithm (a process or set of rules in calculations) for citrate calcium anticoagulation in blood purification systems done outside of the body. The algorithm targets a certain ionized calcium concentration before the blood is filtered. This ensures sufficient levels of anticoagulation during the entire filtration process, as blood can be come into contact with foreign materials or air. The aim of this study is to see if this algorithm for anticoagulation is successful with patients who have chronic liver failure.

Who can participate?
Adults aged 18 to 75 years old with chronic liver disease.

What does the study involve?
Participants are treated two times with the FRESENIUS PrometheusT system (a blood filtration system) in combination with a developed citrate calcium anticoagulation system/algorithm. This occurs for around six hours. Participants are assessed at the beginning of the study, after 15 minutes and every 60 minutes during treatment to measure the level of ionized calcium in their body and in the filtration system.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
University Hospital Graz (Austria)

When is the study starting and how long is it expected to run for?
January 2013 to August 2013.

Who is funding the study?
Center for Biomedical Technology, Danube University Krems (Austria)

Who is the main contact?
Dr. Martin Brandl

Trial website

Contact information



Primary contact

Prof Dieter Falkenhagen


Contact details

Danube University Krems
Dr. Karl Dorrek Str. 30

Additional identifiers

EudraCT number number

Protocol/serial number

CIP V1.0

Study information

Scientific title

Product safety study for a citrate calcium anti-coagulation system and its application for liver insufficiency


Study hypothesis

Specification of a target calcium value in the anticoagulated extracorporeal circuit is associated with a high functionality and high safety using a citrate calcium anticoagulation.

The aim is to gain proof of functionality and safety of an algorithm for automated software controlled regional citrate-calcium anticoagulation applied to patients with liver insufficiency.

Ethics approval

Medical University Graz Ethics Committee, Austria

Study design

Interventional single-arm open-label trial

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Liver insufficiency


Regional anticoagulation with trinatrium citrate and substitution with calcium chloride. Two treatments per patient, with a duration of 6 hours per treatment planned.

Intervention type



Not Applicable

Drug names

Primary outcome measure

The following will be assessed at baseline, after 15 minutes and then every 60 minutes during treatment (maximum treatment duration is 6 hours):
1. Evaluation of the ionized calcium level in the extracorporeal circuit
2. Evaluation of the ionized calcium level in the patient

Secondary outcome measures

The following will be assessed at baseline, after 15 minutes and then every 60 minutes during treatment (maximum treatment duration is 6 hours):
1. Citrate
2. iMg
3. Total Mg
4. Total calcium
5. Activated clotting time (ACT)

The following will be assessed at baseline and end of each treatment period:
1. Blood count
2. Albumin
3. Total protein

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Both males and females with age: 18-75 years
2. Serum Bilirubin > 5 mg/dL (more than 72 h)
3. Model for End Stage Liver Disease (MELD) > 30 (more than 72 h) or
4. Therapeutic resistant hepatic encephalopathy ≥ II° or
5. Therapeutic resistant kidney failure (requiring dialysis) or
6. Therapeutic resistant alcoholic hepatitis or
7. Therapeutic resistant pruritus [Visual Analogue Scale (VAS) > 7]

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. INR > 3
2. Thrombocytes < 30,000
3. Multiorgan failure (liver and > 3 organs)
4. M ean arterial pressure (MAP) < 55 mmHg
5. Acute bleeding (>4 Erythrocyte concentrates in the last 24 hours)
6. Extra hepatic cholestasis

Therapeutic resistance:
1. Hepatic Encephalopathy: Lactulose 60g/d and Ornithin-Aspartate 20g/d i.v. within 72h
2. Kidney failure: volume support albumin 1g/kg-KG, Terlipressin (3 mg/d) within 72h
3. Alcoholic hepatitis: Prednislon 40 mg within 7 days and Lille Score >0.45
4. Pruritus: Cholestyramin 8g and Naltrexone 50 mg within 4 weeks

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Danube University Krems

Sponsor information


Danube University Krems (Austria)

Sponsor details

Dr. Karl Dorrek Str. 30

Sponsor type




Funder type


Funder name

Danube University Krems (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/04/2017: Plain English summary added.