Safety of citrate calcium anti-coagulation system and its use for liver insufficiency

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31779998

Enrollment

Registered

2012-11-13

Start date

2013-01-01

Completion date

Unknown

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver insufficiency Digestive System Hepatic failure, unspecified

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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]

Exclusion criteria

Exclusion criteria: 1. INR > 3 2. Thrombocytes 3 organs) 4. M ean arterial pressure (MAP) 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Austria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026