#1 Clinical Trials Search in Europe

Human Plasma Proteins With Not Less Than 96% Albumin

This article discusses two clinical trials investigating the use of human albumin solutions in different medical contexts. The first trial focuses on patients with decompensated cirrhosis, examining the safety and efficacy of a restored structural profile albumin solution. The second trial explores how albumin levels affect the pharmacokinetics of cefazolin in cardiac surgery patients. Both studies aim to improve patient outcomes and enhance our understanding of albumin’s role in various medical conditions.

Table of Contents

What is Albumin?

Human plasma proteins with not less than 96% albumin, often simply referred to as albumin, is a medication derived from human blood plasma. Albumin is the most abundant protein in human blood and plays crucial roles in maintaining health[1].

Albumin has several important functions in the body:

  • It helps maintain proper fluid balance in your blood vessels and tissues
  • It transports various substances throughout your body, including hormones, vitamins, and medications
  • It helps maintain blood pressure
  • It acts as an antioxidant, protecting your body from harmful substances

Medical Uses of Albumin

Albumin is used to treat various medical conditions, particularly those involving low blood volume or low albumin levels in the blood. Some common uses include:

  • Hypovolemia: A condition where there’s not enough blood circulating in your body
  • Hypoalbuminemia: Low levels of albumin in the blood, which can occur in various diseases
  • Liver disease: Particularly in cases of severe cirrhosis
  • Burns: To help replace lost fluids and proteins
  • Shock: To help restore blood volume
  • Certain types of surgery: To maintain proper fluid balance

Albumin in Decompensated Cirrhosis

One area where albumin is being extensively studied is in the treatment of decompensated cirrhosis. This is an advanced stage of liver disease where the liver can no longer function properly[1].

In decompensated cirrhosis, albumin is used to:

  • Treat ascites (fluid buildup in the abdomen)
  • Prevent complications after removal of ascites fluid (paracentesis)
  • Improve overall liver and kidney function
  • Potentially reduce the risk of infections and other complications

Researchers are currently investigating a new form of albumin called reHA (restored Human Albumin) that may be more effective in treating decompensated cirrhosis[1].

Albumin in Cardiac Surgery

Albumin also plays a role in cardiac (heart) surgery. It’s sometimes used as part of the solution that primes the heart-lung machine used during open-heart surgeries[2].

Additionally, albumin levels can affect how certain medications, like antibiotics, work in the body. Researchers are studying how different albumin levels might impact the effectiveness of antibiotics given during cardiac surgery[2].

How is Albumin Administered?

Albumin is typically given as an intravenous (IV) infusion, which means it’s delivered directly into your bloodstream through a vein[1][2]. The dose and frequency of administration depend on your specific condition and needs.

For example:

  • In cirrhosis treatment, doses might range from 20 to 80 grams, given weekly or biweekly[1]
  • In cardiac surgery, smaller doses of about 6 grams might be used[2]

Safety and Side Effects

Albumin is generally considered safe, as it’s a natural component of human blood. However, like all medications, it can have side effects[1]. These may include:

  • Allergic reactions (rare)
  • Fever
  • Chills
  • Nausea
  • Vomiting

Your doctor will carefully monitor you during and after albumin administration to ensure your safety.

Ongoing Research

Researchers are continually studying albumin to better understand its effects and potential uses. Current areas of research include:

  1. Restored Human Albumin (reHA): This is a new form of albumin that may be more effective in treating decompensated cirrhosis. Researchers are comparing it to standard albumin solutions to see if it can improve liver function and reduce complications more effectively[1].
  2. Albumin and Antibiotic Effectiveness: Studies are looking at how albumin levels in the body might affect how well certain antibiotics work, particularly in patients undergoing cardiac surgery[2].
  3. Long-term Albumin Treatment: Researchers are investigating the benefits and safety of long-term albumin treatment in patients with cirrhosis[1].

These ongoing studies aim to improve our understanding of albumin and potentially expand its uses in medicine.

Aspect Cirrhosis Study Cardiac Surgery Study
Main Focus Safety and efficacy of restored structural profile albumin solution Effect of albumin levels on cefazolin pharmacokinetics
Patient Population Decompensated cirrhosis patients Adult cardiac surgery patients
Primary Endpoint Effective albumin concentration and safety at 1, 3, and 6 months Area under the concentration-time curve for cefazolin
Albumin Product Albunorm 20% (reHA group) Human Albumin ‘CSL Behring’ 20%
Administration Route Intravenous infusion Intravenous
Study Design Randomized, single-blind, controlled Prospective, randomized, open-label, parallel-group
Key Inclusion Criteria Liver cirrhosis, ascites, age 18-85 Planned cardiopulmonary bypass, age 18-90, ejection fraction >40%
Key Exclusion Criteria Recent albumin infusion, active malignancy, organ transplantation Long-standing diabetes, antibiotic allergies, low preoperative albumin

FAQ

  • What is the main purpose of the first clinical trial? The main purpose of the first clinical trial is to assess the impact on effective albumin concentration and the safety of administering a restored structural profile human albumin (reHA) solution compared to a standard commercial albumin solution in patients with decompensated cirrhosis who require long-term albumin treatment.
  • Who can participate in the cirrhosis study? Participants in the cirrhosis study must be diagnosed with liver cirrhosis of any etiology, have grade 2 or 3 ascites (or grade 1 receiving diuretic treatment), be between 18 and 85 years old, and provide written informed consent. However, there are several exclusion criteria, such as recent albumin infusion, ongoing acute complications of cirrhosis, and certain other medical conditions.
  • What is the focus of the second clinical trial? The second clinical trial focuses on how albumin levels affect the pharmacokinetics (how the body processes a drug) of cefazolin, an antibiotic, in adult patients undergoing cardiac surgery. The study compares the area under the concentration-time curve for free and total cefazolin between a control group and an intervention group.
  • What are the inclusion criteria for the cardiac surgery study? To participate in the cardiac surgery study, individuals must provide written informed consent, be planned for cardiopulmonary bypass, be between 18 and 90 years old, and have an ejection fraction greater than 40%. Exclusion criteria include long-standing diabetes, known allergies to certain antibiotics, and preoperative serum albumin concentration below 40g/L, among others.
  • How is albumin administered in these trials? In the cirrhosis study, the reHA solution is administered intravenously, with doses based on body weight. The cardiac surgery study uses Human Albumin 'CSL Behring' 20% solution for infusion, with a maximum daily dose of 6 grams. Both trials use intravenous routes for albumin administration.

Ongoing Clinical Trials on Human Plasma Proteins With Not Less Than 96% Albumin

  • Evaluation of enoxaparin, dalteparin, nadroparin, tinzaparin and human albumin in adults admitted to intensive care unit with acute critical illness

    Recruiting

    1 1 1 1
    Investigated drugs:
    Denmark Finland Iceland The Netherlands Sweden

  • Study on How Albumin Levels Affect Cefazolin in Heart Disease Patients with Low Albumin Undergoing Cardiac Surgery

    Recruiting

    1 1 1 1
    Investigated drugs:
    Austria

  • Study on the Safety and Effectiveness of Human Plasma Proteins and Glutathione for Patients with Decompensated Cirrhosis

    Recruiting

    1 1 1
    Investigated drugs:
    Italy

Glossary

  • Decompensated cirrhosis: An advanced stage of liver disease where the liver can no longer function properly, leading to various complications such as fluid accumulation in the abdomen (ascites), confusion (hepatic encephalopathy), and bleeding disorders.
  • Ascites: The accumulation of fluid in the abdominal cavity, often seen in patients with advanced liver disease or cirrhosis.
  • Albumin: A protein made by the liver that helps maintain fluid balance in the body and carries various substances in the blood.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Cardiopulmonary bypass: A technique used in heart surgery where a machine temporarily takes over the function of the heart and lungs during the operation.
  • Ejection fraction: A measurement of how well the heart pumps blood, expressed as a percentage of blood leaving the heart with each contraction.
  • Cefazolin: An antibiotic used to prevent and treat various bacterial infections, commonly used before and after surgery.
  • Area under the concentration-time curve (AUC): A measure used in pharmacology to represent the total drug exposure over time.
  • Hepatic encephalopathy: A decline in brain function that occurs when the liver is unable to remove toxins from the blood effectively.
  • Diuretic: A type of medication that increases urine production and helps remove excess fluid from the body.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-human-plasma-proteins-and-glutathione-for-patients-with-decompensated-cirrhosis/
  2. http://clinicaltrials.eu/trial/study-on-how-albumin-levels-affect-cefazolin-in-heart-disease-patients-with-low-albumin-undergoing-cardiac-surgery/