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| ID | Type | Description | Link |
|---|---|---|---|
| 825694 | Other Grant/Funding Number | HORIZON 2020 |
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| Name | Class |
|---|---|
| EASL - CLIF Consortium | OTHER |
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The goal of this clinical biomarker validation trial is to test the effect of a predictive biomarker panel to human albumin infusions in patients with liver cirrhosis and ascites. The main questions it aims to answer are:
The predictive biomarker panel will stratify patients into either a high- or low-expected effect of human albumin infusions. Hereafter are participants randomized into treatment arms.
Participants in the active treatment arm will receive regular human albumin infusions during a course of 6 months. Infusions will occur every 10th day for the duration of the study.
Researchers will compare 20% human albumin infusions with regular 0.9% sodium chloride to identify the effects on the number of liver-related events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High expected effect: Human Albumin 20% + Standard Medical Treatment | Active Comparator | Participants stratified to a high expected effect of human albumin and randomized to active treatment with 20% Human Albumin infusions. |
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| High expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment | Placebo Comparator | Participants stratified to a high expected effect of human albumin and randomized to placebo treatment with 0.9% NaCl (saline) infusions. |
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| Low expected effect: Human Albumin 20% + Standard Medical Treatment | Active Comparator | Participants stratified to a low expected effect of human albumin and randomized to active treatment with 20% Human Albumin infusions. |
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| Low expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment | Placebo Comparator | Participants stratified to a low expected effect of human albumin and randomized to placebo treatment with 0.9% NaCl (saline) infusions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human albumin | Drug | 20% Human Albumin infusions (every 10th day +/- 4 days) with dosing according to the participants bodyweight (1.5 grams of albumin per kg bodyweight with a maximum of 100 grams) |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative number of liver-related clinical outcomes | Cumulative number of liver-related clinical outcomes (variceal bleeding, ascites, spontaneous bacterial peritonitis, infection requiring hospitalization, acute kidney injury and overt hepatic encephalopathy) and TIPS (insertion or revision) with death and liver transplantation as counting and censoring events | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-months survival | 6 months | |
| The number of episodes of acute-on-chronic liver failures | Acute-on-chronic liver failure (ACLF) is defined according to the CLIF-C ACLF definition. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksander Krag, Professor | Contact | +4566113333 | albtrial@rsyd.dk | |
| Jonel Trebicka, Professor | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Aleksander Krag, Professor | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katholieke Universiteit Leuven | Recruiting | Leuven | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38355195 | Derived | Torp N, Israelsen M, Coenraad M, Papp M, Shawcross D, Korenjak M, Angeli P, Laleman W, Juanola A, Gines P, Trebicka J, Krag A; MICROB-PREDICT Consortium. Personalised human albumin in patients with cirrhosis and ascites: design and rationale for the ALB-TRIAL - a randomised clinical biomarker validation trial. BMJ Open. 2024 Feb 14;14(2):e079309. doi: 10.1136/bmjopen-2023-079309. |
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There will exist two levels of masking in the current trial. Masking of biostratification outcome (high expected effect of human albumin or low expected effect of human albumin): Participant, Investigator and Outcome Assessor Masking of treatment assignment (human albumin 20% or saline 0.9%): Participant and Outcome Assessor
| sodium chloride | Drug | 0.9% NaCl infusions (every 10th day +/- 4 days) with dosing according to the corresponding volume used of 20% Human Albumin (1.5 grams of albumin per kg bodyweight with a maximum of 100 grams) |
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| Number of organ failures | Where an organ failure is defined according to the CLIF-C ACLF definition. | 6 months |
| Time-to-first liver-related clinical outcome | A liver-related clinical outcome is defined as variceal bleeding, ascites, spontaneous bacterial peritonitis, infection requiring hospitalization, acute kidney injury (>=1B), overt hepatic encephalopathy, TIPS insertion, liver transplantation or death. Time to any of these outcomes are defined as the time from trial inclusion until 1) the date of diagnosis of any of the complications, 2) the date of the procedure (TIPS or liver transplantation) or date of death. | 6 months |
| Change in SF-36 | Quality of life for participants, as measured by Short Form 36 (SF-36), ranging from 0 to 100 with a score of 0 equal to maximum disability and score of 100 no disability. | 6 months |
| Change in CLDQ | Quality of life for participants, as measured by the Chronic Liver Disease Questionnaire (CLDQ), consisting of 29 items within 7 domains. Response on a Likert scale ranging from 1 (most impairment) to 7 (least impairment). Total score by adding score for each item and divide by number of items (29). | 6 months |
| Change in EQ-5D-5L | Quality of life for participants, as measured by the EuroQoL-5 Domain, 5 levels (EQ-5D-5L). Consist of 5 domains with 5 levels where the lowest level (1) is the worst imaginable health and highest level (5) is the best imaginable health. | 6 months |
| Time to first hospital admission (in days) | 180 days |
| Number of hospital admissions | 180 days |
| Days spent on hospitalization (in days) | 180 days |
| Number of intensive care unit admissions | 180 days |
| Length of intensive care unit admissions (in days) | 180 days |
| Number of large volume paracentesis | 6 months |
| Analysis of the cost/effectiveness ratio | Analyzed by an incremental cost-effectiveness ratio (ICER) calculation | 6 months |
| Health economic evaluation | Analyzed by the change in quality-adjusted life years (QALYs) relative to the ICER. | 6 months |
| Changes in serum albumin levels | Measured from baseline and throughout the trial in grams per litre (g/L) | 6 months |
| Number of treatment-related adverse events | Adverse events which are deemed related to the trial intervention | 6 months |
| Number of treatment-related serious adverse events | Adverse events which are deemed related to the trial intervention | 6 months |
| Signatures associated with a poor prognosis as defined by the Microb-Predict biomarker | Change in concentration of the panel of predictive circulating metabolites compared to metabolite levels in other body fluid compartments (blood, urin, stool and saliva) | 6 months |
| Incidence of refractory ascites | 6 months |
| Incidence of variceal bleeding | 6 months |
| Incidence of spontaneous bacterial peritonitis | 6 months |
| Incidence of infection requiring hospitalization | 6 months |
| Incidence of acute kidney injury >= 1B | According to the Kidney Disease: Improving Global Outcomes (KDIGO) definition ranging from stage 1A to 3 where a higher stage is worse. | 6 months |
| Incidence of hepatorenal syndrome acute kidney injury | 6 months |
| Incidence of overt hepatic encephalopathy | 6 months |
| Incidence of liver transplantation | 6 months |
| Incidence of TIPS insertion or revision | 6 months |
| Herlev Hospital | Recruiting | Herlev | Denmark |
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| Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
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| Charité - Universitätsmedizin Berlin | Recruiting | Berlin | Germany |
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| Universitätsklinikum Jena | Recruiting | Jena | Germany |
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| Universitätsklinikum Münster | Recruiting | Münster | Germany |
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| Debreceni Egyetem | Recruiting | Debrecen | Hungary |
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| Academisch Ziekenhuis Leiden | Recruiting | Leiden | Netherlands |
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| Alrijne Ziekenhuis Leiden | Recruiting | Leiderdorp | Netherlands |
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| Hospital Clinic Barcelona | Recruiting | Barcelona | Spain |
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| Hospital Del Mar | Recruiting | Barcelona | Spain |
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| King's College Hospital | Recruiting | London | United Kingdom |
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| ID | Term |
|---|---|
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000075462 | Serum Albumin, Human |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001798 | Blood Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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