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
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
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