Albumin (Human) 25%, USP (Plasbumin®-25) is made from pooled human venous plasma using the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration.
Plasbumin-25 is hyperoncotic and on intravenous infusion will expand the plasma volume by an additional amount, three to four times the volume actually administered, by withdrawing fluid from the interstitial spaces, provided the patient is normally hydrated interstitially or there is interstitial edema.1 If the patient is dehydrated, additional crystalloids must be given,4 or alternatively, Albumin (Human) 5%, USP (Plasbumin®-5) should be used. The patient's hemodynamic response should be monitored and the usual precautions against circulatory overload observed. The total dose should not exceed the level of albumin found in the normal individual, i.e., about 2 g per kg body weight in the absence of active bleeding. Although Plasbumin-5 is to be preferred for the usual volume deficits, Plasbumin-25 with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long-standing shock where treatment has been delayed.2
Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of an albumin infusion may be required to support the blood volume.2
An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours Plasbumin-25 can be used to maintain plasma colloid osmotic pressure.
During major surgery, patients can lose over half of their circulating albumin with the attendant complications of oncotic deficit.2,4,5 A similar situation can occur in sepsis or intensive care patients. Treatment with Plasbumin-25 may be of value in such cases.2
This is characterized by deficient oxygenation caused by pulmonary interstitial edema complicating shock and postsurgical conditions. When clinical signs are those of hypoproteinemia with a fluid volume overload, Plasbumin-25 together with a diuretic may play a role in therapy.
With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient.
In the uncommon situation of rapid loss of liver function with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin.
The administration of Plasbumin-25 may be indicated prior to exchange transfusion, in order to bind free bilirubin, thus lessening the risk of kernicterus. A dosage of 1 g/kg body weight is given about 1 hour prior to exchange transfusion. Caution must be observed in hypervolemic infants.
This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin.
Albumin may be required to avoid excessive hypoproteinemia, during certain types of exchange transfusion, or with the use of very large volumes of previously frozen or washed red cells. About 25 g of albumin per liter of erythrocytes is commonly used, although the requirements in preexistent hypoproteinemia or hepatic impairment can be greater. Plasbumin-25 is added to the isotonic suspension of washed red cells immediately prior to transfusion.
Certain patients may not respond to cyclophosphamide or steroid therapy. The steroids may even aggravate the underlying edema. In this situation a loop diuretic and 100 mL Plasbumin-25 repeated daily for 7 to 10 days may be helpful in controlling the edema and the patient may then respond to steroid treatment.
Although not part of the regular regimen of renal dialysis, Plasbumin-25 may be of value in the treatment of shock or hypotension in these patients. The usual volume administered is about 100 mL, taking particular care to avoid fluid overload as these patients are often fluid overloaded and cannot tolerate substantial volumes of salt solution.
In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid "priming" diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.
Media Articles Related to Plasbumin-25 (Albumin)
Study examines blood markers and survival in patients with ALS
Source: Muscular Dystrophy / ALS News From Medical News Today [2014.07.22]
The blood biomarkers serum albumin and creatinine appear to be associated with survival in patients with amyotrophic lateral sclerosis (ALS) and may help define prognosis in patients after they are...
Diabetic Nephropathy - Early intervention is the key
Source: The Doctors Lounge - Nephrology
Dr. Riham explains how annual screening for microalbuminuria in diabetic patients will allow early identification of nephropathy.
Published Studies Related to Plasbumin-25 (Albumin)
Sulodexide for kidney protection in type 2 diabetes patients with microalbuminuria: a randomized controlled trial. [2011.11]
BACKGROUND: Sulodexide, a heterogenous group of sulfated glycosaminoglycans, includes low-molecular-weight heparin (~80% +/- 8%), high-molecular-weight heparin (~5% +/- 3%), and dermatan (~20% +/- 8%), with a mean molecular weight of ~9 kDa. The drug is absorbed orally and has no anticoagulant effect in the doses used. Small preliminary studies consistently showed sulodexide to be associated with decreased albuminuria in patients with diabetes... CONCLUSION: Sulodexide failed to decrease urine albumin excretion in patients with type 2 diabetic nephropathy and microalbuminuria. Copyright (c) 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.
Pioglitazone delays proximal tubule dysfunction and improves cerebral vessel endothelial dysfunction in normoalbuminuric people with type 2 diabetes mellitus. [2011.10]
AIM: The renal and cerebral protective effects of pioglitazone were assessed in normoalbuminuric patients with type 2 diabetes mellitus (DM)... CONCLUSION: Proximal tubule (PT) dysfunction precedes albuminuria and is dissociated from endothelial dysfunction in patients with type 2 DM. Pioglitazone delays PT dysfunction and improves cerebral vessels endothelial dysfunction in normoalbuminuric patients with type 2 DM. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.
Associations of albuminuria in patients with chronic heart failure: findings in the ALiskiren Observation of heart Failure Treatment study. [2011.07]
CONCLUSIONS: Increased UACR is common in patients with heart failure, including non-diabetics. Urinary albumin creatinine ratio is independently associated with HbA1c and NT-proBNP, even in non-diabetic patients.
Long-term effects of fosinopril and pravastatin on cardiovascular events in subjects with microalbuminuria:Ten years of follow-up of Prevention of Renal and Vascular End-stage Disease Intervention Trial (PREVEND IT). [2011.06]
BACKGROUND: The PREVEND IT investigated whether treatment targeted at lowering urinary albumin excretion (UAE) would reduce adverse cardiovascular events. We obtained extended follow-up data to approximately 10 years to investigate the long-term effects of fosinopril 20 mg and pravastatin 40 mg on cardiovascular outcomes in subjects with UAE >15 mg per 24 hours... CONCLUSIONS: Elevated UAE is associated with increased cardiovascular mortality and morbidity after 9.5 years of follow-up, with a doubling of the risk if the UAE is >50 mg per 24 hours. In this group, the benefits of 4-year treatment with fosinopril were sustained during posttrial follow-up for cardiovascular mortality and morbidity. We propose that UAE be used to estimate risk in the general population and that large clinical trials be designed to confirm the hypothesis that angiotensin-converting enzyme-inhibitor treatment may be beneficial in patients with mildly elevated UAE despite the absence of other comorbidities. Copyright (c) 2011 Mosby, Inc. All rights reserved.
The Albumin in Acute Stroke Part 1 Trial: an exploratory efficacy analysis. [2011.06]
BACKGROUND AND PURPOSE: The Albumin in Acute Stroke (ALIAS) Part 2 Trial is directly testing whether 2 g/kg of 25% human albumin (ALB) administered intravenously within 5 hours of ischemic stroke onset results in improved clinical outcome. Recruitment into Part 1 of the ALIAS Trial was halted for safety reasons. ALIAS Part 2 is a new, reformulated trial with more-stringent exclusion criteria. Our aim was to explore the efficacy of ALB in the ALIAS Part 1 data and to assess the statistical assumptions underlying the ALIAS Part 2 Trial... CONCLUSIONS: Preliminary results from the ALIAS Part 1 suggest a trend toward a favorable primary outcome in subjects treated with ALB and support the validity of the statistical assumptions that underlie the ALIAS Part 2 Trial. The ALIAS Part 2 Trial will confirm or refute these results. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov/ALIAS. Unique identifier: NCT00235495.
Clinical Trials Related to Plasbumin-25 (Albumin)
Study to Evaluate the Safety of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients [Not yet recruiting]
This is a randomized, controlled, open-label clinical trial to be conducted at approximately
12 surgical and pediatric intensive care units (SICU/NICU/PICU) in the US, over a period of
22 months, with 6 months for trial set-up, 12 months of simultaneous subject enrollment and
30 days of treatment/follow-up period, and 3 months for study close-out.
The study population will consist of at least 60 male and female pediatric subjects between
0 days and 12 years of age, undergoing cardiac, abdominal, orthopedic or transplant surgery
with an approximately equal number of subjects (n=10 to 25) in three of the four age groups:
(29 days to 23 months), (2 to 5 years 11 months) and (6 years to 12 years) cohorts.
Regarding the youngest age group of 0 to 28 days, the minimum number of patients to be
enrolled in the study will not be predefined as very a small number of elective surgical
procedures is expected in this population.
Safety concerns and eventual safety signals, as well as recruitment rate, will be monitored
annually (starting from the enrollment of the 60th subject) by an independent Safety
Monitoring Board (SMB), which will be appointed prior to study initiation and submitted to
the FDA. The responsibilities of the SMB will be defined in ad hoc document, in which the
threshold for acceptable safety will also be set.
During the conduct of the study on the first 60 patients, if there is any safety signal
linked to the primary safety endpoint (i. e. pulmonary fluid overload) or imbalance in the
incidence of AEs between the treatment and control groups or based on relevant literature,
as judged by the SMB, the enrolment will be increased to 100 patients using the same age
stratification approach defined above (n=20 to 30 in each age group).
Potential subjects will be pre-screened and informed consent/assent will be obtained from
the subject and/or subject's parents or guardians prior to surgery. Post-surgery, the
subject will be admitted to the Surgical, Neonatal, or Pediatric Intensive Care Unit
(SICU/NICU/PICU) for postoperative recovery and care management. Subjects who show signs of
hypovolemia as judged by the Principal Investigator (PI) will be screened to determine their
eligibility to participate in this trial. Subjects will then be randomized to receive
treatment with Kedbumin 25% or the comparator, normal saline (sodium chloride 0. 9%).
There is no specific post-treatment regimen for this protocol, as all subjects will receive
the standard post-operative care based on their clinical status and response to treatment at
the discretion of the Investigator.
Vital signs and fluid management/replacement therapy recorded in the medical chart and
results of standard complete blood count (CBC), biochemistry, and hematology and coagulation
lab panels will be reviewed and recorded by research staff at specified time points,
according to the hospital standard of care. Additionally, research staff will review and
record daily lactate, urine albumin, blood urea nitrogen (BUN), creatinine, and non-invasive
measurements at the following time points: Baseline, 6hr, 12hr, 24hr, 36hr, 48hr, and 72hr
post-onset of hypovolemia), until hemodynamic stability is achieved. Hemodynamic stability
will be evaluated based on site-specific age-defined reference ranges for heart rate, blood
pressure, urine output, and cardiac index in children.
The volume, rate and frequency of the Investigational Medicinal Product (IMP, either
Kedbumin 25% or normal saline) administered will be recorded in addition to the type,
timing, and amount of all other fluids administered. The time to hemodynamic stability,
duration of stability once attained, and any relapse requiring additional treatment or use
of secondary resuscitation strategies will be recorded. Subjects who demonstrate hemodynamic
stability within 3 days after treatment initiation and then relapse into hemodynamic
instability as a result of surgical complications or infection will exit from the study, but
the data be considered for the safety analysis. These subjects should continue treatment
according the clinical practice standard since the study is not intended to evaluate the
efficacy of Kedbumin 25%.
Determination of a Safe Dose of Optison in Pediatric Patients With Solid Tumors [Suspended]
St. Jude Children's Research Hospital is studying ways to make ultrasound images clearer - to
be able to see blood vessels, body structures, and tumors better. Ultrasound uses sound waves
to create pictures, allowing doctors and other medical professionals to "see" inside the
Researchers are studying a contrast agent (like a dye) called Optison™. St. Jude Children's
Research Hospital researchers want to learn the best and safest dose of this ultrasound
Treatment of Subarachnoid Hemorrhage With Human Albumin [Recruiting]
The purpose of this study is to evaluate the tolerability and safety of 25 percent human
albumin therapy in patients with subarachnoid hemorrhage.
Human Albumin for the Treatment of Ascites in Patients With Hepatic Cirrhosis [Recruiting]
Ascites is the most frequent complication of liver cirrhosis and carries a significant
worsening of the prognosis. Approximately 10% of patients per year develop refractory
ascites because of either the lack of response to medical treatment or the onset of
diuretic-induced complications that preclude the use of an effective dosage. Refractory
ascites is associated with an increased incidence of severe complications of cirrhosis.
Thus, the overall probability of survival of patients with refractory ascites is very poor,
being approximately 30% at 2 years. Repeated large-volume paracentesis, transjugular
intrahepatic portosystemic shunt (TIPS), and liver transplantation represent the therapeutic
alternatives for refractory ascites. As renal sodium retention and ascites formation are the
consequence of portal hypertension and effective hypovolemia, the preservation of the
central blood volume represents a major purpose in the management of patients with advanced
cirrhosis. Although albumin is responsible for about 70% of the plasma oncotic pressure, the
absence of large multicenter randomized studies together with its high cost explains why
albumin infusion is not usually included among the therapeutic options for
The objective of the present study is to define the effectiveness of the prolonged
administration of human albumin in the treatment of liver cirrhosis with ascitic
decompensation. This goal will be reached by performing a multicenter, prospective,
randomized clinical trial comparing the efficacy of chronic albumin administration on top of
standard medical treatment versus standard medical treatment alone in patients with
cirrhosis and ascites.
The study will be conducted in 44 Italian clinical centers and will enrol 440 in- or
out-patients affected by liver cirrhosis with uncomplicated ascites who will be randomized
with a ratio of 1: 1. The duration of the study for each patient is 18 months from
randomization. The enrolment of patients will last 18 months and will be competitive between
centers. Treatment will be interrupted if one of the following condition occur: orthotopic
liver transplantation, TIPS, need of 3 paracentesis/month (indication to TIPS), patient
refusal to continue, and medical judgement.
An ancillary optional study will be performed in a subset of patients to analyze the
non-oncotic properties of albumin.
Efficacy and Safety of Plasma Exchange With 5% Albutein in Beta-Amyloid Peptide Clearance in Cerebrospinal Fluid [Recruiting]
The purpose of this study is to evaluate the efficacy and safety of plasma exchange with 5%
albumin in beta-amyloid peptide clearance in cerebrospinal fluid, and its effects in
patients with mild-moderate Alzheimer's disease.
Page last updated: 2014-07-22