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)
Overall prevalence of diabetic kidney disease does not change significantly in U.S.
Source: Diabetes News From Medical News Today [2016.08.12]
Among U.S. adults with diabetes from 1988 to 2014, the overall prevalence of diabetic kidney disease did not change significantly, while the prevalence of albuminuria declined and the prevalence of...
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)
Glycated albumin predicts the effect of dual and single antiplatelet therapy on
recurrent stroke. 
recurrence of stroke in patients on either dual or single antiplatelet therapy... CONCLUSIONS: GA could be a potential biomarker to predict the effects of dual and
Effects of combined lipoic acid and pyridoxine on albuminuria, advanced glycation
end-products, and blood pressure in diabetic nephropathy. 
This study was designed to investigate the effects of combined administration of
lipoic acid and pyridoxine on albuminuria, oxidative stress, blood pressure,
serum advanced glycation end-products, nitric oxide (NO), and endothelin-1 in
patients with diabetic nephropathy.
High-dose albumin treatment for acute ischaemic stroke (ALIAS) Part 2: a
randomised, double-blind, phase 3, placebo-controlled trial. 
proportion of patients with a favourable outcome... INTERPRETATION: Our findings show no clinical benefit of 25% albumin in patients
Albumin resuscitation for traumatic brain injury: is intracranial hypertension
the cause of increased mortality? 
Mortality is higher in patients with traumatic brain injury (TBI) resuscitated
with albumin compared with saline, but the mechanism for increased mortality is
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.
Clinical Trials Related to Plasbumin-25 (Albumin)
Treatment of Subarachnoid Hemorrhage With Human Albumin [Terminated]
The purpose of this study is to evaluate the tolerability and safety of 25 percent human
albumin therapy in patients with subarachnoid hemorrhage.
Efficacy and Safety of Plasma Exchange With 5% Albutein in Beta-Amyloid Peptide Clearance in Cerebrospinal Fluid [Completed]
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.
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%.
Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase I Study in Chinese Healthy Volunteers [Completed]
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of
Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese
Treatment of Subarachnoid Hemorrhage With Human Albumin [Terminated]
The proposed study was set up to evaluate the tolerability and safety of 25% human albumin
(HA) therapy in patients with subarachnoid hemorrhage (SAH). It is estimated that 37,500
people in the USA have SAH every year. SAH is associated with a 51% mortality rate and one
third of survivors are left functionally dependent. Cerebral vasospasm (CV) has been
identified as the most important reason for neurological deterioration. CV may be due to
multiple molecular mechanisms. The use of a neuroprotective agent with various actions,
likes HA, would be important for prevention of CV and improved clinical outcome in patients
with SAH. The proposed open-label, dose-escalation study will have important public health
implications by providing necessary information for a definitive phase III clinical trial
regarding the efficacy of treatment with HA in patients with SAH. The study was to enroll a
maximum of 80 patients with SAH who meet the eligibility criteria. Four dosages of HA
(0. 625, 1. 25, 1. 875, and 2. 5 g/kg) administered daily for seven days will be evaluated. The
lowest dosage was to be evaluated in the first group of 20 subjects. A specific safety
threshold was defined based on data from previous studies. The Data and Safety Monitoring
Board approved or disapproved advancing to the next higher HA dosage based on the evaluation
of the rate of congestive heart failure (CHF). The study assessed three outcomes: safety and
tolerability of the HA dosages and the functional outcome. The primary tolerability outcome
was defined as the subject's ability to receive the full allocated dose of HA without
incurring frank CHF that requires termination of treatment. Secondary safety outcomes were
serious adverse events (including neurological and medical complications, and anaphylactic
reactions). Neurological complications comprise incidence of CV, rebleeding, hydrocephalus,
and seizures after treatment. The three-month functional outcome determined, by Glasgow
Outcome Scale, Barthel Index, modified Rankin Scale, NIH Stroke Scale and Stroke Impact
Scale was measured to obtain a preliminary estimate of the treatment effect of HA. The
timeline of the study is three years.
Page last updated: 2016-08-12