AlbuRx (human albumin) / CSL Behring - LARVOL DELTA

Efficacy and Safety of Outpatient Human Albumin Infusions in Patients with Decompensated Cirrhosis and Ascites: A Real-World Cohort Study from Australia (APASL 2025) - "Inclusion criteria included patients with cirrhosis who had commenced regular HA (Albumex20 or Alburex20, CSL Ltd, Australia) at least 6 months prior to data collection. This study represents the largest real-world cohort of patients with cirrhosis receiving regular HA infusions outside Italy. While comorbidities and alcohol consumption remain prevalent, the rates of paracentesis and inpatient admissions are low among this decompensated population. Despite recent safety concerns, only two minor adverse events were recorded."

Clinical • Real-world • Real-world evidence • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Fibrosis • Hematological Disorders • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Nephrology • Pain • Renal Disease • Respiratory Diseases • Thrombosis

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE) (clinicaltrials.gov) - P=N/A | N=174 | Not yet recruiting | Sponsor: General Hospital of Shenyang Military Region | Initiation date: Oct 2024 ➔ May 2025

Trial initiation date • CNS Disorders • Fibrosis • Gastroenterology • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis

Prolonging neutrophil room temperature storage with clinically-approved solutions: Implications for granulocyte transfusion. (PubMed, J Leukoc Biol) - "Our findings provide proof of concept that mixtures of clinically-approved additives can be tailored to significantly prolong the viability and function of freshly isolated neutrophils during room temperature storage. The unique additive composition of this storage solution that we developed for freshly isolated neutrophils, requires further optimization for use with pooled, residual leukocyte units as well as the time point at which the solution is added during processing to prolong the viability and functions of neutrophils in this blood product."

Journal • Infectious Disease

FLINDERS ALBUMIN IN THE HOME (FAITH): A FEASIBILITY STUDY (AASLD 2024) - "A community nursing service visited the patient, obtained IV access, and administered HA as per the following protocol (loading dose of Alburex 40g twice a week the first 2 weeks, then 40g weekly, with each 100 ml bottle of albumin infused over at least 45 minutes)... HA administration at home appears feasible, safe, effective and has high participant acceptability relative to hospital-based infusions. HA may provide a logistical and cost effective option to administer albumin in cirrhosis. Larger studies validating our pilot study findings are indicated."

Cardiovascular • Congestive Heart Failure • Fibrosis • Heart Failure • Hepatology • Immunology

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE) (clinicaltrials.gov) - P=N/A | N=174 | Not yet recruiting | Sponsor: General Hospital of Shenyang Military Region | Initiation date: Jul 2024 ➔ Oct 2024

Trial initiation date • CNS Disorders • Fibrosis • Gastroenterology • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis

Flinders Albumin in the Home (FAITH): A feasibility study (AGW-GESA 2024) - "A community nursing service visited the patient, obtained IV access, and administered HA as per the following protocol (loading dose of Alburex 40g twice a week the first 2 weeks, then 40g weekly, with each 100 ml bottle of albumin infused over at least 45 minutes)... HA administration at home appears feasible, safe, effective and has high participant acceptability relative to hospital-based infusions. HA may provide a logistical and cost effective option to administer albumin in cirrhosis. Larger studies validating our pilot study findings are indicated."

Cardiovascular • Congestive Heart Failure • Fibrosis • Heart Failure • Hepatology • Immunology

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE) (clinicaltrials.gov) - P=N/A | N=174 | Not yet recruiting | Sponsor: General Hospital of Shenyang Military Region

New trial • CNS Disorders • Fibrosis • Gastroenterology • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis

Comparison of Fluid Resuscitation in Pediatric Burn Patients Using Crystalloids and With Albumin on Day Two. (clinicaltrials.gov) - P2/3 | N=90 | Completed | Sponsor: King Edward Medical University

New P2/3 trial • Pediatrics • Thermal Injury

Cerebral O and CO transport in isovolumic haemodilution: Compensation of cerebral delivery of O and maintenance of cerebrovascular reactivity to CO. (PubMed, J Cereb Blood Flow Metab) - "Replacement of ∼20% of blood volume with an equal volume of 5% human serum albumin (Alburex® 5%) reduced haemoglobin (13.8 ± 0.8 vs. 11.3 ± 0.6 g/dL; P < 0.001) and CaO (18.9 ± 1.0 vs 15.0 ± 0.8 mL/dL P < 0.001), elevated gCBF (+18 ± 11%; P = 0.002), preserved cerebral oxygen delivery (P = 0.49), and elevated CO washout (+11%; P = 0.01). The net cerebral uptake of nitrite (11.6 ± 14.0 nmol/min; P = 0.027) at baseline was abolished following haemodilution (-3.6 ± 17.9 nmol/min; P = 0.54), perhaps underpinning the conservation of CVR (61.7 ± 19.0 vs. 69.0 ± 19.2 mL/min/mmHg; P = 0.23). These findings demonstrate that the cerebrovascular responses to acute anaemia in healthy humans are sufficient to support the maintenance of CVR."

Journal • Hematological Disorders

Albumin Normalization to Prevent Hypotension and Recovery From Severe Acute Kidney Injury (clinicaltrials.gov) - P2; N=80; Not yet recruiting; Sponsor: Ottawa Hospital Research Institute

New P2 trial • Acute Kidney Injury • Cardiovascular • Hypotension • Nephrology • Renal Disease • Urology

Chloride and Other Electrolyte Concentrations in Commonly Available 5% Albumin Products. (PubMed, Crit Care Med) - "This study is the first to identify and document a statistically significant variability in the chloride concentration of available 5% albumin products. This study has also informed a pilot randomized controlled trial examining the effect of administering high chloride versus low chloride fluids in critically ill patients with sepsis."

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