Clinical Guideline

Guideline for the use of human

albumin solution (HAS)

Guideline Summary
This document outlines the indications for the use of human albumin solution in
adult and paediatric patients at Guy’s and St. Thomas’ NHS Foundation Trust.

Document Detail
Document Type Guideline
Document name Guideline for the use of human albumin solution (HAS)
Document location Gti
Version 1.0
Effective from May 2015
Review date May 2017
Owner Hospital Transfusion Committee
Authors Dr Andrew Retter
Dr Susan Robinson
Dr Michael Robson
Dr Christopher Reid
Dr Paul Holmes
Dr Toby Garrood

Approved by, date 15-5-2015

Keywords Albumin, HAS, ECMO, sepsis, critical care, renal, liver, neurology,
plasma exchange
Relevant external law, NA
regulation, standards

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INDEX

1.0 Introduction 3
2.0 Background and rationale for use 4
Modified ASFA Guideline Indications for PEX Categories
3.0 Demand management and ordering 7
HAS Demand management colour coding and definition
Human Albumin Solution Assessment Panel designated speciality
consultant
Demand management programme
4.0 Prescribing, Consent, Traceability 12
5.0 Potential risks 12
6.0 Guidance for the use of 20% HAS 13
7.0 Guidance for the use of 4.5% and 5% HAS 15
8.0 Plasma Exchange 16
9.0 References 18

Appendices
1.0 Modified ASFA 2013 Indication Categories for Plasma Exchange with 4.5% or 5% 20
HAS within service provision GSTT
2.0 Modified AFSA Category IV relevant to this guidance 21
3.0 Human albumin solution assessment panel terms of reference 22

KEY POINTS: This document

• Provides guidance on HAS indications and contraindications.
• Provides guidance on the Trust HAS demand management programme.
• Provides guidance how to request HAS.

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1.0 Introduction
Human albumin solution (HAS) is widely used in clinical practice. However, there is no
formal guidance governing its use in the UK and in many clinical situations there is a
limited evidence base and a number of alternatives exist. The widespread use of HAS,
combined with restrictions on the use of UK derived plasma following concerns over
possible transmission of nvCJD and production issues have led to high cost and
shortages. Currently the UK faces an acute shortage in the supply of 4.5% HAS and
potentially 20% HAS. This document provides clinical guidance to clinicians regarding
the HAS indications and contraindication and details the Trust demand management
programme and how to request HAS. The demand management programme aims to
ensure usage is restricted to the most appropriate indications and alternatives
considered where possible to ensure adequate stocks remain of this finite blood
product. The demand management programme will be revised if shortages worsen or
the Department of Health implement a demand management programme which differs.
This document will also serve as a reference point to facilitate future audit. The
guideline should be used by all staff involved in issuing, prescribing, consenting and
administering HAS.

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2.0 Background and rationale for use.
HAS preparations are traditionally available in 4.5% and 20% preparations and in view of the
recent shortage a 5% preparation will also become more available. The 4.5% and 20%
preparations are very different in their scope and should not be used interchangeably. The
4.5% solution has the same oncotic pressure as plasma and its uses are quite different from
the hyperoncotic 20% solution. The benefits of HAS are controversial, proponents argue that
in addition to maintaining plasma oncotic pressure that HAS has a number of secondary
functions which might be beneficial. These secondary functions include an anti-oxidant
potential, endothelial stabilisation, an anti-inflammatory effect and the binding and transport
of numerous plasma constituents and drug. However, two Cochrane reviews published in
1998 and updated in 2011 concluded that there was no evidence that HAS reduces mortality
when compared to cheaper alternatives such as saline (1, 2).

The largest study evaluating the clinical use of HAS was the SAFE study (3). The overall
conclusion of the study was that resuscitation with HAS or normal saline resulted in similar
outcomes at 28 days. However, additional analyses of the SAFE data yielded interesting data
in two specific subgroups. Firstly resuscitation with HAS was associated with a significantly
increased rate of death at 2 years in patients who had suffered a traumatic brain injury
(relative risk, 1.63; 95% CI 1.17 to 2.26; P=0.003). In the subgroup of patients with severe
sepsis, the relative risk of death among those randomly assigned to receive HAS as opposed
to saline was 0.87 compared to 1.05 (95% CI 0.74 to 1.02; p=0.09). The recent ALBIOS
study specifically examined the use of HAS in patients with severe sepsis. The trial showed
that the use of 20% HAS in the first 7 days of an ITU admission was associated with a higher
mean arterial pressure (P=0.03) and a lower net fluid balance (P=<0.001) but there was no
significant difference in overall survival (4).

Over the last 3 years there has been a 50% increase in the use of HAS nationally. Use has
increased in light of a number of studies demonstrating negative outcomes with the use of
colloids. The 6S trial revealed an increased mortality rate at 90 days with 6% hydroxyethyl
starch compared to Ringer’s acetate (5). These findings were corroborated by the CHEST
study, which was conducted in 7000 critically ill patients. CHEST showed no difference in
overall mortality but there was an increased need for renal replacement therapy and an
increased incidence of renal failure (6). As a result of these studies there was a change in
the surviving sepsis guidelines and a high level (grade 1B) recommendation was made
recommending against the use of hydroxyethyl starch for fluid resuscitation in severe sepsis
and septic shock. Although no definitive data is yet available it is the belief of a number of
opinion leaders that these studies and the change in surviving sepsis guidelines has resulted
in the increased use of HAS.

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20% HAS has an established role in patients with ascites who require large volume
paracentesis, develop hepatorenal syndrome or have spontaneous bacterial peritionitis. It is
also used in some paediatric patients with nephrotic syndrome (7, 8).

An area in which considerable amounts of 4.5 % and 5% HAS are used is apheresis,
specifically plasma exchange (PEX). The main indications for plasma exchange, with
associated published evidence, are well set out in the American Society for Apheresis (ASFA)
(9) American Academy of Neurology (AAN(10)) (11) and Kidney Disease Improving Global
Outcomes (KDIGO) and the British Committee for Standards in Haematology (BCSH)
guidelines (12). ASFA produces regularly updated evidence-based guidelines. The 2013 ASFA
guidelines detail indications for apheresis including plasma exchange (PEX) in categories I-IV
(Table 1) and use the Grading Recommendations Assessment, Development and Evaluation
(GRADE) system for grading evidence (9). These categories have been modified and
incorporated into the Trust HAS demand management plan. Designated speciality consultants
have been contacted to confirm usage within Guy’s and St Thomas’ NHS Foundation Trust
(GSTT) including the Evelina London Children’s Hospital. The indications for PEX relevant to
these services that usually require volume replacement with 4.5% or 5% HAS are included in
appendix 1 with category and grade of evidence. Indications, which are currently outside of
these services have been excluded to simplify this document. Category IV clinical conditions
are detailed separately in appendix 2.

Table 1. Modified ASFA Guideline Indications for PEX Categories

Category I
Disorders for which apheresis is accepted as first-line therapy, either as a primary standalone
treatment or in conjunction with other modes of treatment.
Category II
Disorders for which apheresis is accepted as second line therapy, either as a standalone
treatment or in conjunction with other modes of treatment.
Category III
Optimum role of apheresis therapy is not established.
Category IV
Disorders in which published evidence demonstrates or suggests apheresis to be ineffective
or harmful.

In general PEX should be considered for first line treatment of Category I indications and
second line treatment of Category II indications. Category III indications should be

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considered on a case-by-case basis or within a trial setting. Category IV is a list of clinical
conditions where PEX is not appropriate. The volume, frequency and total number of PEX’s
needs to be a consultant based decision in keeping with current guidelines (9, 11, 12) Where
no national guidance is available for a specific indication, Trust guidelines need to be
developed and circulated to the HASAP prior to directorate Clinical Guideline Group and Drugs
and Therapeutics Committee (DTC) approval.

According to the British Committee for Standards in Haematology (BCSH) Apheresis guidance
(12). “Except for Thrombotic Thrombocytopenic Purpura (TTP) and related thrombotic
microangiopathies in which Solvent Detergent-Fresh Frozen Plasma must be used as the sole
replacement fluid for plasma exchange (13), 4.5% to 5% HAS Solution is the most widely
used replacement fluid for plasma exchange in the UK (UK Transfusion Services, unpublished
data) and also worldwide (14). In contrast to crystalloids such as 0.9% normal saline, HAS
maintains the patient’s whole blood viscosity and physiological HAS levels. Some centres also
use crystalloid solutions as partial replacement fluid for plasma exchange, to reduce cost and
minimise blood product exposure, but there is a lack of published data to demonstrate
equivalent safety to HAS, and the incidence of vasovagal faints may be increased (15).

Whilst this guideline provides a demand management plan for HAS including the use of HAS
volume replacement for PEX volume replacement, it does not reference or provide guidance
with regards to PEX and replacement fluid in Thrombotic Thrombocytopenic Purpura (TTP)
and related thrombotic microangiopathies in which Solvent Detergent-Fresh Frozen Plasma
(Octoplas) must be used as the sole replacement fluid for PEX. Further Guidance specific to
apheresis and the apheresis service and TTP is available separately on the Trust intranet

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3.0 Demand management and ordering HAS

In view of national shortages and increasing use of HAS a demand management programme
has been introduced within the Trust and will be implemented and managed by the Human
Albumin Solution Assessment Panel (HASAP) (Appendix 3 - terms and references HASAP)
chaired by the clinical lead for transfusion. These local guidelines, define usage indications
according to a colour code or modified ASFA PEX Category to enable demand management
(Table 2), the HASAP designated speciality consultants (Table 3) and provide a 3 stage plan
regarding requests, authorisation and use of albumin during times of normal supply, shortage
and severe shortage albeit local or national (Table 4). Following notification of a national or
local change in supply level a clinical alert and consultant communication will be sent out by
the chair or a HASAP member and a further alert will be issued when supply level returns to
normal.

At all times HAS usage must be a consultant based decision. Whether supplies are normal or
a shortage is identified the responsible consultant should discuss all usage, except red
indications or category I PEX, with the HASAP designated speciality consultant between 09:00
– 17:00 who may authorise requests. Grey indications or category III PEX will require
approval by two HASAP designated speciality consultants and will be coordinated by the
HASAP designated speciality consultant. During any shortage no grey indication or Category
III PEX will be authorised. During a severe shortage HASAP will meet virtually following
notification and plan to manage all albumin requests case-by-case, all requests will require
agreement of 2 HASAP members and will be coordinated by the HASAP designated speciality
consultant.

When HAS is requested between 17:00-09:00 (out of hours) and supplies are normal or a
shortage is identified the responsible consultants must follow this guidance and request
retrospective authorisation for all usage except red indications or category I PEX. When a
decision to use HAS is made out of hours whether supplies are normal or a shortage is
identified HAS will only be made available for red or blue indications or category I PEX.

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Table 2 HAS Demand management colour coding and definition

Red: Treatment is considered the highest priority because of a risk to life without treatment.
Automatic approval.

Blue: A condition where there is a reasonable evidence base but other treatment options are
available. Where appropriate other alternative therapies should be used. Approval by HASAP
designated speciality consultant.

Grey: Conditions where the evidence base is weak. Treatment should be considered on a
case-by-case basis. HAS usage should be prioritised to red and blue indications. Approval
requires two HASAP designated speciality consultants, which will be coordinated by the
HASAP designated speciality consultant.

Black: Evidence suggests that the use of HAS is not an appropriate treatment and is not
recommended.

Table 3 Human Albumin Solution Assessment Panel designated speciality

consultant
- Renal – Dr Michael Robson
- Intensive care unit – Dr Andrew Retter
- Neurology – Dr Paul Holmes
- Rheumatology- Dr Toby Garrood
- Evelina London Children’s Hospital – Dr Christopher Reid
- All other – Dr Susan Robinson

When supplies are normal or a shortage is identified for PEX indications where 4.5% or 5%
HAS is the volume replacement of choice, the responsible consultant will be required to
discuss the indication for PEX with the HASAP designated speciality consultant except
category I indications. Category II authorisation will require evidence of failed first line
treatment, category III will require agreement of two HASAP designated speciality
consultants which will be coordinated by the HASAP designated speciality consultant.
Category IV lists disorders in which published evidence demonstrates or suggests apheresis
to be ineffective or harmful and will not be authorised. For unlisted conditions where removal
of a pathogenic antibody makes biological sense providing there is no published evidence that
plasma exchange is ineffective or detrimental in the condition in question will be treated as
category III. During a shortage no authorisation of albumin for Category III PEX will be
given. During a severe shortage HASAP will meet virtually following notification and plan to

8
manage all albumin requests case-by-case, all requests will require agreement of 2 HASAP
members and will be coordinated by the HASAP designated speciality consultant.

If no albumin is made available for PEX the responsible consultant and apheresis team will
need to consider alternative volume replacement. At present the Trust has made a decision
not to dilute 20% albumin, however it is noted that some preparations include instruction in
the SPC re dilution to achieve a 4.5 or 5% solution.

Prior to contacting the blood bank to request HAS an EPR request must be completed which
includes details of authorising consultant and enables review of Trust usage Figure 1 (to go
live 20.05.2015). Once this EPR request has been completed the requesting clinician must
telephone the blood bank and verify the order. The Biomedical Scientist (BMS) will review the
order and issue the HAS. The BMS will not be able to issue HAS if the details of the form are
incomplete. Between 09:00-17:00 Monday to Friday all requests require detail of the
authorising HASAP consultant excluding red or category I PEX. Outside of these times the
requestor must chose the drop down “out of hours-retrospective authorisation required”.

A regular report (frequency to be determined according to shortage) will enable the HASAP to
review HAS issued. Where retrospective authorisation is required this report will enable
confirmation retrospective consent has been obtained via the HASAP designated speciality
consultants.

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Table 4. Demand management programme

Supply Red Category I Blue Category II Grey Category III Black/Category IV

Normal Request 24/7* Request 24/7* Request 24/7* Only request Only request Only request DO NOT USE
09:00-17:00 09:00-17:00 09:00-17:00

Automatic Automatic HASAP HASAP HASAP HASAP

authorisation authorisation Authorisation Authorisation Authorisation Authorisation
Required** Required Required *** Required ***

Shortage Request 24/7* Request 24/7* Request 24/7* Only request DO NOT USE DO NOT USE DO NOT USE
09:00-17:00

Automatic Automatic HASAP HASAP

authorisation authorisation Authorisation Authorisation
Required** Required

Severe HASAP HASAP HASAP HASAP DO NOT USE DO NOT USE DO NOT USE
Shortage Authorisation Authorisation Authorisation Authorisation
Required *** Required *** Required *** Required ***

• * The trust will endeavour to enable albumin to be made available 24/7 for these indications
• ** Between the hours of 17:00-09:00 Retrospective authorisation is required
• *** 2 HASAP members must authorise

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Figure 1.EPR Screen Shot-EPR tool in progress planned to go live 20.05.2015 at
present seek authorisation according to guidance and clinical alert and contact
blood bank to request albumin

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4.0 Prescribing, Consent, Traceability
HAS is issued by the Trust blood bank. Similar to other plasma products it is
produced by the fractionation of donated whole blood. As HAS is a blood product it
must be prescribed for a specific patient and is subject to the same scrutiny and
reporting mechanisms as other plasma products including traceability. Consent from
the patient must be obtained prior to administration. It is important to remember
that patients, who refuse blood products, may decline treatment.

5.0 Potential risks

Blood products are inherently very safe in the UK, however, specific risks associated
with the use of HAS include:
1. Circulatory overload
2. Infusion/allergic reactions
3. Theoretical risk of transmission of nvCJD

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6. Table 5 Indications for the Administration of 20% HAS

Intensive Care – Indications for the administration of 20% HAS

Indication Details Dose References
Acute lung injury and severe Should be used in conjunction with - 100 to 200mls 20% - Martin (16)
respiratory failure frusemide or another strategy to control HAS transfused over - Martin (17)
fluid balance such as renal replacement 30 to 60mins to target - ALBIOS Study (4)
therapy. serum albumin - 1998 and 2011 Cochrane reviews (1, 2)
concentration >25g/l*
Clear fluid balance goals MUST be - Adult doses
charted in electronic ITU patient
record (Phillips IntelliSpace CCA®).
Severe sepsis and septic shock NOT routinely used NOT routinely used - Surviving Sepsis Campign Guideline (18)
• Maybe used in patients with refractory - 100 to 200mls 20% - ALBIOS Study (4)
septic shock who have received HAS transfused over - 1998 and 2011 Cochrane reviews (1, 2)
resuscitation with crystalloid and require 30 to 60mins - VAST study (19)
>0.2mcg/kg/min of norepinephrine. - Adult doses

Volume resuscitation for NOT routinely used NOT routinely used

hypovolaemia or weaning - Maybe used in patients with gross fluid - 100 to 200mls 20% - 1998 and 2011 Cochrane reviews (1, 2)
from mechanical ventilation overload and on low dose inotropes to HAS transfused over - ALBIOS Study (4)
facilitate weaning from organ supportive 30 to 60mins
therapy. - Adult doses
Liver disease – Indications for the administration of 20% HAS
Indication Details Dose References
Hepatorenal syndrome Eligible for liver transplantation in Day 1: 1g/kg - Sanyal (20)
conjunction with vasoactive drugs Day 2 -14: 0.5g/kg - Gluud (21)

The transfusions should

stopped once patient’s
condition has resolved.

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Liver disease (cont.) – Indications for the administration of 20% HAS
Indication Details Dose References
Spontaneous bacterial All patients in conjunction with appropriate - Day 1 and 2: 1.5g/kg - Nazaret (22)
peritonitis antibiotics – to be used as per GSTT - Day 3 onwards: 1g/kg - Sort (23)
antimicrobial guidance - Fernandez (24)
- until significant
improvement in the
patients clinical
condition
Paracentesis Should be given for all paracentesis. - 100mls of 20% HAS - Lata (25)
Please see trust guideline: Particularly in critical care consideration should be given for
Management of ascites in should be given to using terlipressin. Oral every 3L of ascites
cirrhosis for further midodrine may be appropriate on rare drained.
information. occasions.
Paediatric kidney disease – Indications for the administration of 20% HAS
Indication Details Dose References
Childhood nephrotic syndrome Children with
a) severe refractory oedema; under - 1g/kg over 6 hours, - Haws (26)
supervision of consultant paediatric with or without - British Association on Paediatric
nephrologist frusemide depending Nephrology Consensus Statement (27)
b) symptoms and signs of sub-acute on clinical indication
intravascular volume depletion, and assessment
including oliguria, poor peripheral during 20% HAS
perfusion, abdominal pain, raised infusion
creatinine and haematocrit; under
supervision of consultant paediatric
nephrologist
Tables adapted from Ontario Regional Blood Coordinating Network

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7. Table 6: Indications for the use of 4.5% or 5% HAS solution

Intensive Care – Indications for the administration of 4.5% or 5% HAS

Indication Details Suggested dose References
Burns/thermal injuries Usually for burns greater than 50% Body Should not be routinely - use to be determined by a consultant
Surface Area (BSA). used intensivist.
Consideration must be made to
transfer the patient to a burn centre in
this scenario

Volume resuscitation in NOT routinely used and MAY produce harm Should not be routinely - SOAP Study (28)
hypovolaemia in the critically ill used - SAFE Study (3)
- 1998 and 2011 Cochrane reviews (1, 2)

Traumatic brain injury Evidence suggest patient harm Do not use – evidence - SAFE Study (3)
suggests harm
Plasma Exchange – use 4.5% or 5% HAS only
Renal, Rheumatology, Decision to PEX must be a consultant Risk assess individual
Neurology, respiratory.. decision case and consider a 1:2
0.9% saline: 4.5% or 5%
HAS volume replacement

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8.0 Plasma exchange (PEX)
4.5% to 5% HAS Solution (HAS) is the most widely used replacement fluid for PEX. Some
centres use crystalloid solutions as partial replacement fluid for plasma exchange, to reduce
cost and minimise blood product exposure, but there is a lack of published data to
demonstrate equivalent safety to HAS. When commencing PEX the responsible consultant
should risk assess whether a 1:2 (0.9% saline: 4.5% or 5% HAS volume replacement)
instead of only 4.5% or 5% HAS alone is acceptable based upon the clinical indication and
clinical risk factors with regards to maintaining intravascular volume. Any incidents related to
the use of 0.9 % saline need to be reported via the Trust incident reporting system.

Coagulation parameters should be maintained according to the table 7 below.

Table 7. Coagulation and full blood count parameter’s regarding PEX

Group 1 Group 2 Group 3

– pts with low risk of
bleeding
Target INR and APTTr <1.5
Target Fibrinogen >1g/l
Target Platelets >25x109/l
- pts with a high risk of
bleeding e.g. renal
biopsy with in 48hrs
Target INR and APTTr <1.3
Target Fibrinogen >1.5g/l
Target Platelets >75x109/l
- pts with active
haemorrhage e.g.
haemoptysis
Target INR and APTTr <1.3
Target Fibrinogen >1.5g/l
Target Platelets >75x109/l

Group 1 – patients with a low risk of bleeding

Coagulation including a Clauss fibrinogen and full blood count (FBC) should be checked 4hrs
before each plasma exchange, ideally early in the morning before the planned PEX.

IF the INR or APTTr are >1.5 15ml/kg of SDFFP (Octaplas) should be given at the end of the
exchange as part of the exchange fluid. If the fibrinogen concentration is <1g/l 2 pools of
cryoprecipitate should be given at the end of the exchange.

IF the INR or APTTr are >3 or platelet <10x109/l these should be corrected prior to
commencing the plasma exchange in discussion with the transfusion consultant.

16
Group 2 – patients with a high risk of bleeding within the last 48 hours e.g.
patients with renal biopsy.

As a minimum 15ml/kg SDFFP (Octaplas) should be given at the end of the first and each
subsequent PEX as part of the exchange fluid. This is because coagulation becomes
predictably prolonged with the first PEX though this partially resolves at 4 hours. The
coagulation profile should be checked at the end of the procedure and a further 15ml/kg
SDFFP (Octaplas) should be given if the INR or APTTr is >1.3. If the fibrinogen concentration
is <1.5g/l 2 pools of cryoprecipitate should be given. Transfusion of platelets maybe required
to maintain the platelet count >75x109/l.

Group 3 - Patients with active haemorrhage e.g. pulmonary haemorrhage or

diffuse alveolar damage

SDFFP (Octaplas) should be used for PEX during active haemorrhage. There is a significant
risk of exacerbating pulmonary haemorrhage when HAS is used alone. When the patient’s
condition has improved and there is no further active haemorrhage a clinical decision should
be made by the responsible consultant for the patient with regards to switching to PEX with
saline/ HAS or to stopping PEX.

17
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Nephrology and Research Unit, Royal College of Physicians. Arch Dis Child. 1994;70(2):151-7.
28. Vincent JL, Sakr Y, Reinhart K, Sprung CL, Gerlach H, Ranieri VM, et al. Is albumin
administration in the acutely ill associated with increased mortality? Results of the SOAP
study. Crit Care. 2005;9(6):R745-54.

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Appendix 1: Modified ASFA 2013 Indication Categories for Plasma
Exchange with 4.5% or 5% HAS within service provision GSTT

Disease Name Category Grade

Acute disseminated encephalomyelitis II 2C
Guillain Barre Syndrome (Acute inflammatory II 1A
demyelinating polyneuropathy)
ANCA-associated vasculitis (Severe) I 1A-2C
Anti-glomerular basement membrane disease I 1C-2B
Catastrophic Antiphospholipid syndrome II 2C
Chronic focal encephalitis (Rasmussen III 2C
Encephalitis)
Chronic inflammatory demyelinating II 1B
polyradiculoneuropathy
Cryoglobulinaemia I 2A
Focal segmental glomerulosclerosis I – recurrent in transplanted kidney 1B
Henoch-Schonlein purpura II 2C
Hypertriglyceride pancreatitis III 2C
Hyperviscosity in monoclonal gammopathy I 1B-C
Immunoglobulin A nephropathy II 2B-2C
Lambert-Eaton myasthenic syndrome II 2C
Multiple Sclerosis III 1B
Myasthenia gravis II 1B
Neuromyelitis optica (Devic’s syndrome) II 1B
Paraneoplastic neurological syndromes II 2C
Paraproteinemic demyelinating I – IgG/IgA/IgM 1B-1C
polyneuropathies III – multiple myeloma 2C
PANDAS; Sydenham’s chorea II 1B
Phytanic acid storage disease (Refsum’s II 2C
disease) II 2C
Renal Transplant Desensitisation (ABOi/ HLAi) I 1B
Renal Transplant Humoral Rejection I 1B
Stiff person syndrome II 2B
Systemic Lupus Erythmatosis-severe II 2C
Autoimmune encephalitis II 1C

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Appendix 2 Modified AFSA Category IV relevant to this guidance

Disease name
Amyloidosis, systemic
Amyotrophic lateral sclerosis
Coagulation factor inhibitors (alloantibody)
Dermatomyositis and polymyositis
Immune thrombocytopenia
Inclusion body myositis
POEMS syndrome
Psoriasis
Renal transplantation ABO incompatible Group A2/A2B into B deceased donor
Schizophrenia
Systemic lupus erythematosus nephritis

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Appendix 3 Human Albumin Solution Assessment Panel (HASAP) terms of
reference

At GSTT the HASAP will report to the Drug and Therapeutics Committee and will be a “virtual
panel”, meeting annually unless conditions of shortage are severe or a meeting is called by
the chair.

1. Establish and embed local policy

The committee is responsible for:

1.1 Establishing and reviewing the Demand Management Plan within GSTT.
1.2 Actively promoting the implementation of guidelines for the appropriate use of HAS.
1.3 Ensuring that hospital guidelines for the use of HAS are up to date and reviewed on a
regular basis.
1.4 Ensuring the ability of up to date information about HAS, alternatives and any potential
shortages.
1.5 Developing a robust mechanism for informing users when shortages of HAS occur.
1.6 Ensuring the Trust is compliant with NHS England and Department of Health
requirements.

2. Approve applications for use of HAS

2.1 Review and consider approving applications for HAS

3. Respond to shortage situations

3.1 During shortages of HAS the committee is responsible for reviewing the availability and
local applications to try to ensure that sufficient HAS is available for patients with Red
indications and Category I PEX.
3.2 To ensure that the views and requirements of the purchaser (GSTT) are considered at
both local and national levels and inform Department of Health (DH) and Commercial
Medicines unit (CMU) of any local shortages.

4. Monitor and review Trust usage

4.1 The HASAP is responsible for overseeing the overall use of HAS by the Trust and for
periodically reviewing data.
4.2 This data shall be reported to the Drug and Therapeutics Committee and users of HAS.

5. Clinical Trials

5.1 Review and approve research proposals for studies involving HAS

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