Safety of citrate calcium anti-coagulation system and its use for liver insufficiency
| ISRCTN | ISRCTN31779998 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31779998 |
| Secondary identifying numbers | CIP V1.0 |
- Submission date
- 05/09/2012
- Registration date
- 13/11/2012
- Last edited
- 07/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Danube University Krems
Dr. Karl Dorrek Str. 30
Krems
3500
Austria
Study information
| Study design | Interventional single-arm open-label trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet [German] |
| Scientific title | Product safety study for a citrate calcium anti-coagulation system and its application for liver insufficiency |
| Study objectives | 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(s) | Medical University Graz Ethics Committee, Austria |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2013 |
| Completion date | 31/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 8 |
| Key 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] |
| Key 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 |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 31/08/2013 |
Locations
Countries of recruitment
- Austria
Study participating centre
3500
Austria
Sponsor information
University/education
Dr. Karl Dorrek Str. 30
Krems
3500
Austria
| Website | http://www.donau-uni.ac.at/ |
|---|---|
"ROR" |
https://ror.org/03ef4a036 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
07/04/2017: Plain English summary added.
