Table of contents
- Trial overview
- Stroke and brain protection
- Critical illness and septic shock
- Surgery and fluid management
- Liver transplantation and kidney outcomes
- Other patient groups
- What the trials measure
Trial overview
The trial data show that Human Albumin Solution is being studied in different hospital settings, mostly in interventional trials, where researchers give a treatment and compare results.[1] The studies include people with stroke, liver transplantation, surgery, septic shock, and other serious conditions.[1] The phases range from Phase 1 to Phase 3, so the research includes both early safety studies and later studies that test effectiveness in larger groups.[1]
Stroke and brain protection
The MOZEG study is a Phase 2 trial in people with ischemic stroke, which means a stroke caused by blocked blood flow to the brain.[1] It is designed to test whether low-dose albumin can protect the endothelial glycocalyx, a thin protective layer on blood vessel cells, and support endothelial function, which is how the inner lining of blood vessels works.[1] The main outcomes are the concentration of syndecan-1 in blood serum and GAG in urine, which are markers used to look at vessel injury and protection.[1]
Critical illness and septic shock
One Phase 2 trial studies patients in intensive care with very severe septic shock, meaning a dangerous infection with organ failure and low blood pressure.[1] The population includes hospitalized ICU patients with at least two non-hemodynamic organ failures for less than 12 hours, so this is a very sick and early-stage critical care group.[1] The main endpoint is the SOFA score at day 7, or earlier if the patient dies or leaves intensive care, to see whether treatment changes organ failure over time.[1]
Surgery and fluid management
Several trials study Human Albumin Solution during surgery, where doctors need to manage fluids and blood volume carefully.[1][1] The ALBU-CHIP trial is a Phase 3 study in people having cytoreductive surgery with hyperthermic intraperitoneal chemotherapy, and it compares human 20% albumin plus Ringer Lactate with Ringer Lactate alone.[1] Its main outcome is the Comprehensive Complication Index at day 28, which measures the overall burden of postoperative complications.[1]
Another Phase 3 study compares albumin and Ringer’s solution for optimizing plasma volume and hemodynamics during laparoscopic surgery.[1] Hemodynamics means blood flow and circulation, and plasma volume means the fluid part of the blood.[1] The main outcome is hemoglobin drop after a fluid bolus, studied with a kinetic model, which is a mathematical way to describe how the body responds to fluids.[1]
Liver transplantation and kidney outcomes
The HALT trial is a Phase 3 study in people after liver transplantation.[1] It tests whether albumin administration to keep serum albumin above 30 g/L for five days can reduce acute kidney injury in the first 7 days after transplant compared with a more restricted albumin strategy.[1] The primary outcome is acute kidney injury measured by KDIGO criteria, which are standard rules used to define kidney injury.[1]
Other patient groups
One completed Phase 2 study in people with moderate to severe hypertriglyceridemia included albumin among several study drugs and focused on safety, local tolerability, vital signs, ECG, laboratory tests, and adverse events.[1] A Phase 1 study in newly diagnosed high-risk neuroblastoma also included Human Albumin Baxalta as part of the treatment plan, and its main goal was to find dose-limiting toxicities, which are side effects that stop dose increases.[1] Another Phase 1/2 trial in generalised myasthenia gravis included ALBUMIN among many interventions, but the main focus was safety and tolerability of TOL2 in AChR antibody seropositive patients, not albumin itself.[1]
There is also a Phase 2 study of sentinel node imaging in patients with melanoma of the head or neck, upper trunk, oral malignancies, or penile carcinoma, but this trial uses indocyanine green and technetium nanocolloid rather than Human Albumin Solution.[1] Because the request is focused on Human Albumin Solution, this study is not part of the main albumin evidence base described here.[1]
What the trials measure
The main outcomes across these trials are focused on patient recovery and safety, not just on laboratory values.[1][1][1][1] Examples include organ failure scores, kidney injury, complication indexes, blood and urine markers, ECG findings, and adverse events.[1][1][1][1][1]
Some studies compare Human Albumin Solution with another fluid such as Ringer Lactate or a restricted albumin strategy, while others use it as part of a broader treatment plan in serious illness or surgery.[1][1][1] The target groups are highly specific, so these trials are not general screening studies for healthy volunteers.[1][1][1][1]
