Condition category
Digestive System
Date applied
05/09/2012
Date assigned
13/11/2012
Last edited
07/04/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
Martin.brandl@donau-uni.ac.at

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dieter Falkenhagen

ORCID ID

Contact details

Danube University Krems
Dr. Karl Dorrek Str. 30
Krems
3500
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov 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

Acronym

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

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Liver insufficiency

Intervention

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

Other

Phase

Not Applicable

Drug names

Primary 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. 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

01/01/2013

Overall trial end date

31/08/2013

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

8

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

01/01/2013

Recruitment end date

31/08/2013

Locations

Countries of recruitment

Austria

Trial participating centre

Danube University Krems
Krems
3500
Austria

Sponsor information

Organisation

Danube University Krems (Austria)

Sponsor details

Dr. Karl Dorrek Str. 30
Krems
3500
Austria

Sponsor type

University/education

Website

http://www.donau-uni.ac.at/

Funders

Funder type

University/education

Funder name

Danube University Krems (Austria)

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

07/04/2017: Plain English summary added.