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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004809-33 | EudraCT Number |
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
To assess whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) improves survival at 90 days (mortality endpoint treated as a composite endpoint death and/ or liver transplantation).
To evaluate whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) improves survival at 30, 90 and 180 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human albumin | Active Comparator | human albumin in the 24-48 hours after the hospitalization and at 48+/- 24 hours after the first dose. |
|
| placebo | Placebo Comparator | saline serum 0.9% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human albumin | Drug | 1.5gr/Kg/day at least in the 24-48 hours after the hospitalization and 1.0 gr/Kg/day at 72 hours after the first dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation). | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 180 days. | 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joan Genescà Ferrer | Contact | jgenesca@vhebron.net | ||
| Inmaculada Fuentes Camps, MD | Contact | 934894113 | 4881 | usic@vhir.org |
| Name | Affiliation | Role |
|---|---|---|
| German Soriano | Hospital de la Santa creu i Sant Pau - Barcelona | Principal Investigator |
| Jordi Sanchez | Corporació Sanitària Parc Taulí, Sabadell | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol | Recruiting | Badalona | Barcelona | Spain |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000075462 | Serum Albumin, Human |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Placebo | Drug |
|
| Helena Masnou |
| Hospital Universitari Germans Trias i Pujol, Badalona |
| Principal Investigator |
| Núria Cañete | Hospital del Mar | Principal Investigator |
| Marta Martín | Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí | Principal Investigator |
| Elsa Solà | Hospital Clinic of Barcelona | Principal Investigator |
| Corporació Sanitària Parc Taulí | Recruiting | Sabadell | Barcelona | Spain |
|
| Hospital de Sant Joan Despí Moisès Broggi | Recruiting | Sant Joan Despí | Barcelona | Spain |
|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
|
| Hospital Clínic de Barcelona | Recruiting | Barcelona | Spain |
|
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Spain |
|
| Hospital del Mar | Recruiting | Barcelona | Spain |
|
| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001798 |
| Blood Proteins |