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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,

regulation, standards

NA

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INDEX

1.0 Introduction 3

2.0 Background and rationale for use

Modified ASFA Guideline Indications for PEX Categories

4

3.0 Demand management and ordering

HAS Demand management colour coding and definition

Human Albumin Solution Assessment Panel designated speciality

consultant

Demand management programme

7

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

1.0

2.0

3.0

Appendices

Modified ASFA 2013 Indication Categories for Plasma Exchange with 4.5% or 5%

HAS within service provision GSTT

Modified AFSA Category IV relevant to this guidance

Human albumin solution assessment panel terms of reference

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21

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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

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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*

Automatic authorisation

Request 24/7*

Automatic authorisation

Request 24/7*

HASAP Authorisation

Required**

Only request 09:00-17:00

HASAP Authorisation

Required

Only request 09:00-17:00

HASAP Authorisation

Required ***

Only request 09:00-17:00

HASAP Authorisation

Required ***

DO NOT USE

Shortage Request 24/7*

Automatic authorisation

Request 24/7*

Automatic authorisation

Request 24/7*

HASAP Authorisation

Required**

Only request

09:00-17:00

HASAP Authorisation

Required

DO NOT USE DO NOT USE DO NOT USE

Severe

Shortage

HASAP

Authorisation

Required ***

HASAP

Authorisation

Required ***

HASAP

Authorisation

Required ***

HASAP

Authorisation

Required ***

DO NOT USE DO NOT USE DO NOT USE

• * 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

respiratory failure

Should be used in conjunction with

frusemide or another strategy to control

fluid balance such as renal replacement therapy.

Clear fluid balance goals MUST be

charted in electronic ITU patient record (Phillips IntelliSpace CCA®).

- 100 to 200mls 20%

HAS transfused over

30 to 60mins to target serum albumin

concentration >25g/l* - Adult doses

- Martin (16)

- Martin (17)

- ALBIOS Study (4) - 1998 and 2011 Cochrane reviews (1, 2)

Severe sepsis and septic shock NOT routinely used

• Maybe used in patients with refractory

septic shock who have received resuscitation with crystalloid and require

>0.2mcg/kg/min of norepinephrine.

NOT routinely used

- 100 to 200mls 20% HAS transfused over

30 to 60mins

- Adult doses

- Surviving Sepsis Campign Guideline (18)

- ALBIOS Study (4) - 1998 and 2011 Cochrane reviews (1, 2)

- VAST study (19)

Volume resuscitation for

hypovolaemia or weaning from mechanical ventilation

NOT routinely used

- Maybe used in patients with gross fluid overload and on low dose inotropes to

facilitate weaning from organ supportive therapy.

NOT routinely used

- 100 to 200mls 20% HAS transfused over

30 to 60mins - Adult doses

- 1998 and 2011 Cochrane reviews (1, 2) - ALBIOS Study (4)

Liver disease – Indications for the administration of 20% HAS

Indication Details Dose References

Hepatorenal syndrome

Eligible for liver transplantation in conjunction with vasoactive drugs

Day 1: 1g/kg Day 2 -14: 0.5g/kg

The transfusions should

stopped once patient’s condition has resolved.

- Sanyal (20) - Gluud (21)

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Liver disease (cont.) – Indications for the administration of 20% HAS

Indication Details Dose References

Spontaneous bacterial peritonitis

All patients in conjunction with appropriate antibiotics – to be used as per GSTT

antimicrobial guidance

- Day 1 and 2: 1.5g/kg - Day 3 onwards: 1g/kg

- until significant

improvement in the patients clinical

condition

- Nazaret (22) - Sort (23)

- Fernandez (24)

Paracentesis Please see trust guideline: Management of ascites in cirrhosis for further information.

Should be given for all paracentesis. Particularly in critical care consideration

should be given to using terlipressin. Oral

midodrine may be appropriate on rare occasions.

- 100mls of 20% HAS should be given for

every 3L of ascites

drained.

- Lata (25)

Paediatric kidney disease – Indications for the administration of 20% HAS

Indication Details Dose References

Childhood nephrotic syndrome Children with a) severe refractory oedema; under

supervision of consultant paediatric

nephrologist b) symptoms and signs of sub-acute

intravascular volume depletion, including oliguria, poor peripheral

perfusion, abdominal pain, raised

creatinine and haematocrit; under supervision of consultant paediatric

nephrologist

- 1g/kg over 6 hours, with or without

frusemide depending on clinical indication

and assessment during 20% HAS

infusion

- Haws (26)

- British Association on Paediatric

Nephrology Consensus Statement (27)

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

Surface Area (BSA). Consideration must be made to transfer the patient to a burn centre in this scenario

Should not be routinely

used

- use to be determined by a consultant

intensivist.

Volume resuscitation in hypovolaemia

NOT routinely used and MAY produce harm in the critically ill

Should not be routinely used

- SOAP Study (28) - SAFE Study (3)

- 1998 and 2011 Cochrane reviews (1, 2)

Traumatic brain injury Evidence suggest patient harm Do not use – evidence

suggests harm

- SAFE Study (3)

Plasma Exchange – use 4.5% or 5% HAS only

Renal, Rheumatology,

Neurology, respiratory..

Decision to PEX must be a consultant decision

Risk assess individual

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

– pts with low risk of

bleeding

Group 2

- pts with a high risk of

bleeding e.g. renal

biopsy with in 48hrs

Group 3

- pts with active

haemorrhage e.g.

haemoptysis

Target INR and APTTr <1.5 Target INR and APTTr <1.3 Target INR and APTTr <1.3

Target Fibrinogen >1g/l Target Fibrinogen >1.5g/l Target Fibrinogen >1.5g/l

Target Platelets >25x109/l Target Platelets >75x109/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.

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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.

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nephrotic syndrome. Pediatrics. 1993;91(6):1142-6. 27. Consensus statement on management and audit potential for steroid responsive

nephrotic syndrome. Report of a Workshop by the British Association for Paediatric

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.

20

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

demyelinating polyneuropathy)

II

1A

ANCA-associated vasculitis (Severe) I 1A-2C

Anti-glomerular basement membrane disease I 1C-2B

Catastrophic Antiphospholipid syndrome II 2C

Chronic focal encephalitis (Rasmussen

Encephalitis)

III

2C

Chronic inflammatory demyelinating

polyradiculoneuropathy

II 1B

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

polyneuropathies

I – IgG/IgA/IgM

III – multiple myeloma

1B-1C

2C

PANDAS; Sydenham’s chorea II 1B

Phytanic acid storage disease (Refsum’s

disease)

II

II

2C

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

21

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

22

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