Granulocyte colony stimulating factor (G-CSF) to treat acute-on-chronic liver failure: Amulticentre randomized trial
Not Applicable
- Conditions
- acute-on-chronic liver failureK72.0Acute and subacute hepatic failure
- Registration Number
- DRKS00011572
- Lead Sponsor
- niversität Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 176
Inclusion Criteria
Acute-on-chronic liver failure according to the criteria defined by the CANONIC study [Moreau 2013] / age >= 18 years / Informed consent
Exclusion Criteria
Prior not curatively treated or active malignancies / sickle cell disease / septic shock, defined by the following symptom complex: bacteraemia AND SIRS AND shock / WBC-count of > 50 x 109/L / known HIV infection / known intolerance to filgrastim / pregnancy, lactation or insufficient contraception / participation in other interventional clinical trials
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Transplant-free survival up to 90 days (death or transplant count as events)
- Secondary Outcome Measures
Name Time Method •Overall survival at 360 days<br>•Transplant-free survival at 360 days<br>•Complications of ACLF within 90 days/within 360 days (hepatorenal syndrome, variceal bleeding, ascites, hepatic encephalopathy)<br>•Infections within 90 days/within 360 days (proven infection necessitating systemic use of antibiotics)<br>•Liver function during the course of treatment and follow-up (MELD-Score, Child-Pugh-Score)<br>•Duration of initial hospital stay<br><br>Assessment of safety:<br>In addition to the complications of ACLF listed above, further AEs and SAEs will be assessed. Laboratory values reflecting liver function as well as infection related parameters will be monitored during the course of treatment and follow-up.<br>