Guidelines for Therapeutic Plasma Exchange

Department of Nephrology 1
Guidelines for Therapeutic Plasma Exchange

BEAUMONT HOSPITAL

Transplantation, Urology & Nephrology Directorate

GUIDELINES FOR THERAPEUTIC PLASMA EXCHANGE.

Date Developed: Developed By: Brian Carey CNMI & Alma Seale CNMI
March-June 2011
Date of Approval:
July 2011
Date of Approval: Approved By:

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Date Effective Review Date:
From: July 2013 or sooner if amendments required.
July 2011
Document Number: Supersedes all previous versions.

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Guidelines for Therapeutic Plasma Exchange

TABLE OF CONTENTS
PAGE
1.0 Guideline Statement 3
2.0 Aims / Purpose 3
3.0 Scope of Guideline 3
4.0 Definition 3-4
5.0 Responsibilities
5.1 NURSING RESPONSIBILITIES 4
5.2 MEDICAL RESPONSIBILITIES 4
5.3 CONTACTING TPE STAFF
6.0 Procedure
6.1 REFERRALS 5
6.2 INDICATIONS FOR THERAPEUTIC PLASMA EXCHANGE 5-7
6.3 INDICATIONS FOR EMERGENCY TPE 7
6.4 CALCULATION OF TPE VOLUME 8
6.5 PATIENT ASSESSMENT PRIOR TO TPE 8-9
6.6 PRE-TPE NURSING CARE ASSESSMENT 10
6.7 POST TPE NURSING CARE ASSESSMENT 11
6.8 COMPLICATIONS OF TPE 11
6.9 GUIDELINES FOR MANAGEMENT OF ANAPHYLACTIC REACTION 12
7.0 Distribution 12
8.0 Filing 12
9.0 Review 12
10.0 Superseded / Obsolete Documents 12
11.0 Recommended Reading 13
12.0 Appendix 1 (Patient information leaflet) 14-15

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Guidelines for Therapeutic Plasma Exchange

1.0 Guideline Statement.

Therapeutic Plasma Exchange (TPE) will be undertaken by competent nephrology nurses who will
perform extracorporeal therapies safely and effectively.

2.0 Aim / Purpose of Guideline.

This document aims to guide both medical and nursing staff in the treatment of patients undergoing
plasma treatment.
.
3.0 Scope of Guideline.
This guideline applies to patients who require and undergo TPE, registrars and consultants who
prescribe and nursing staff who deliver the treatment.
Nursing staff must be:

Registered General Nurse

2 years haemodialysis experience

Educated and trained in the procedure of TPE

4.0 Definition
Therapeutic Plasma Exchange (TPE) is a procedure in which blood of the patient is passed through a
medical device which separates out plasma from other components of blood, the plasma is removed and
replaced with a/or replacement solutions such as fresh frozen plasma (FFP) and/or 5% human albumin
with NaCl 0.9% (ASFA 2007).

FUNCTIONS OF TPE IN RELATION TO THE MOST COMMON CONDITIONS

Removal of Circulating Factor:

Antibody: (Anti-GBM disease, Myasthenia Gravis, Guillian Barre Syndrome, antibody mediated transplant rejection)
Monoclonal Protein: (Myeloma protein, Waldenstrom's macroglobulaemia)
Circulating Immune Complexes: (Cryoglobulanaemia.
Alloantibody: (RH alloimmunization in pregnancy)
Toxic Factor: (TTP, HUS, FSGS)

Replenishment of Specific Plasma Factor:

Thrombotic Thrombocytopenia Purpura (TTP)

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Guidelines for Therapeutic Plasma Exchange

Other Effects on the Immune System

Improvement in function of reticuloendothelial system.
Removal of inflammatory mediators.
Shift in antibody to antigen ratio resulting in more soluble immune complexes.
Stimulation of lymphocyte clones to enhance cytotoxic therapy.

5.0 RESPONSIBILITIES
Nursing and medical staff must be aware and knowledgeable as to why TPE would be a rational
treatment choice.

5.1 NURSING RESPONSIBILITIES:

Educated and deemed competent in TPE.

Assess patient status prior to TPE.

Maximise patient comfort.

Educate patient about TPE & provide information leaflet (see appendix1)

Plan and deliver safe effective treatment.

Documentation of treatment.

5.2 MEDICAL RESPONSIBILITIES:

Appropriate assessment of patient prior to commencement of TPE

Placement of adequate vascular access for treatment and documented ready for use.

Co-ordinating with CNM/nurse in charge in St Martins Room 2/ St Peters HD regarding planning and
timing of patient treatments.

Co-ordinating with CNM in St Martins Room 2/St Peters HD in relation to other
treatments/procedures/investigations planned for the same day as TPE treatments.

Liaising with CNM/nurse in relation to prescription development and charting of TPE and ensure
EPV calculation is documented in the medical notes.

Aware of availability of TPE programme (Mon-Fri 8am-4pm)

Educated in relation to what defines URGENT TPE
5.3 CONTACTING TPE STAFF
TPE Clinical Nurse Managers can be contacted on extension 2757/2723 or outside of normal hours
please contact Clinical Nurse Manager / Nurse in Charge in St. Martins ward on ext 2731/2730.
The TPE service is available Monday Friday 8am 4pm. However, if a condition is deemed a medical
emergency (see section 6.3) and treatment is required urgently contact ext 2757/2731, or outside of
working hours contact Clinical Nurse Manager /Nurse in Charge in St. Martins ward. Every effort
will be made to facilitate urgent requests for TPE treatment.
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Guidelines for Therapeutic Plasma Exchange
6.0 PROCEDURE
6.1 REFERRALS

Each Consultant Nephrologist is responsible for the management of TPE treatments for patients under
their care

Patients referred for TPE from other departments are referred to the Consultant Nephrologist On
Call for that week.

If the patient requires further TPE treatments in the future, they will be referred back to the original
Nephrologist.

The Consultant Nephrologist/team is responsible for the initial assessment of the patient.

Their responsibilities include decisions regarding prescription, number of treatments, type of vascular
access, however in the majority of cases the anaesthetic team insert the central lines.

TPE treatment is normally carried out on stable patients in the TPE room on Hamilton ward, or in
one of the haemodialysis rooms. Unstable or acutely ill patients may require TPE treatment to be
performed in St Peters HD or on their core ward, where they can be monitored from an overall base
perspective by their referring Consultant.

FOR TPE REFERRALS FROM OUTSIDE THE RENAL DIRECTORATE THE REFERING
TEAM SHOULD ENSURE THE FOLLOWING OCCURS.

Ensure admission virology is obtained. Available on PIPE Admission Virology (ADMVIR) and HEP
C PCR (AnnHCV) 6 stickers will print but only 2 large white top bottles are required.

Once taken the samples should be hand delivered to St Peters HD, where they will be dispatched to
the laboratory.

Ensure appropriate vascular access is in place to perform treatment and documented ready for use.

Please ensure a Type and Screen is sent to the lab as this is required for SDP (Solvent Detergent
Plasma) exchange.

Co-ordinate with appropriate Renal Registrar and CNM regarding planning and timing of treatments.

Co-ordinate with CNM in St Martins Room 2 (2757)/St Peters HD (2723) in relation to other
treatments/procedures/investigations planned for the same day as TPE treatments.

Ensure peripheral vascular access is in place.

6.2 INDICATIONS FOR TPE

Therapeutic plasma exchange is a useful treatment for a multitude of diseases with many beneficial
effects. The ASFA (American Society for Apheresis) provides a framework for clinical decisions.
They regularly review evidence for each given indication. Guidelines have been published in which
disorders can be categorised from category 1 to category 4.

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Table 1
Category I Standard acceptable therapy
Category II Sufficient evidence to suggest efficiency usually as adjunctive therapy
Category III Suggestion of benefit for which evidence is insufficient to establish the efficiency of
TPE or to clarify the risk/benefit ratio associated with TPE
Category IV lack of efficiency in controlled trials.

Table 2 Indication Category for therapeutic plasma exchange

Disease group and name
Neurological ASFA2007
Guillain-Barre syndrome I
CIDP I
Polyneuropathy with IgG/IgA monoclonal protein I
Polyneuropathy with IgM monoclonal protein II
Myasthenia gravis I
Stiff-person syndrome III
Lambert-Eaton myasthenic syndrome II
Paraneoplastic neurologic syndromes III
Multiple sclerosis acute CNS inflammatory demyelinating disease II
Rasmussens encephalitis II

Renal
ANCA-associated rapidly progressive glomerulonephritis (Wegeners granulomatosis) or pulmonary
haemorrhage II
Anti-Glomerular basement membrane disease (Goodpastures syndrome)
I
Haemolytic uremic syndrome
II

Focal segmental glomerulosclerosis

Primary III

Overdosing/poisoning
Mushroom poisoning II
Other compounds III
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Phytanic acid storage disease (Refsums disease) II

Haematological
ABO-incompatible marrow transplant II
Aplastic anaemia: pure red cell aplasia II
Autoimmune haemolytic anaemia III
Coagulation factor inhibitor III
Hyperviscosity in monoclonal gammopathies I
Post transfusion purpura III
Pure red cell aplasia III
Red cell alloimmunization in pregnancy II
Thrombotic thrombocytopenia purpura I

AUTOIMMUNE
Catastrophic antiphospholipid syndrome III
Cryoglobulinemia I
Pemphigus III

6.3 INDICATIONS FOR EMERGENCY PLASMAPHERESIS

There are situations when plasma can improve or reverse a life-threatening or organ threatening
situation associated with a disease process.
1.Anti-GBM disease
2. Hyperviscosity syndrome
3. Poisoning involving protein-bound toxins ( herbicides, mushrooms)
4.TTP/HUS.

6.4 CALCULATION OF TPE VOLUME

To prescribe TPE in a rational manner, the amount of plasma to be exchanged must be determined in
relation to the patient's estimated plasma volume (EPV).

Estimated Plasma Volume (EPV) can be calculated from the patient's weight and PCV using the
following formula: EPV = (0.07 x Patient Weight in Kgs)x (1-PCV)

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According to calculations done in previous studies, if the volume exchanged is equal to the patient's
EPV, pre-treatment antibody levels will be lowered by 63%. If the plasma exchanged volume is equal to
1.4 times the patient's EPV the pre-treatment antibody levels will be lowered by 75%. Hence for most
indications, each treatment should provide an exchange volume equalling 1 to 1.4 times the EPV(A.
Kaplan 1990).

Rebound and re-equilibration between the extra vascular system and the intravascular system of large
molecular weight substances is relatively slow (1 to 3%/hr) therefore several consecutive treatments are
essential to remove a substantial percentage of the total body burden. Treatments should occur at 24 to
48 hour intervals. Initial courses of 5 to 7 sessions are advised but is dependant on patient condition.

6.5 PATIENT ASSESSMENT PRIOR TO TPE

Physical examination including patient weight.

Blood levels: CBC, Coag Screen, U&E, CPM corrected calcium, specific antibody levels in
accordance with patient condition, type & screen for ordering replacement fluid and HCV PCR on
transplant patients.

Vascular access is required. Temporary access in the form of a large bore haemodialysis catheter
inserted into the internal jugular or femoral vein are required for TPE. The medical team are
responsible for the placement and removal of all central lines. An existing functioning AVF can also
be used.

Chest x-ray performed post insertion of central venous catheters in the internal jugular vein to
determine the correct positioning of the access and that is free of complications. This must be
documented as ready for use in the patients medical notes along with the type of access inserted prior
to any TPE being undertaken by nursing staff.

Prescribing replacement fluids lease with CNM regarding the prescribing/ordering of same from
haematology/ blood bank (2705).
-Standard replacement prescription is usually 5% albumin and NaCl 0.9%.
-In cases of hyper viscosity syndrome all NaCl 0.9% should be used.
-If patient is post Renal Biopsy or experiencing pulmonary haemorrhage some SDP (solvent
detergent plasma) should be used for the exchange.
-In cases of TTP/HUS all SDP (solvent detergent plasma) should be used.
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Blood Product Transfusion Record must have replacement fluid 5 % Human Albumin or SDP
prescribed.

Drug Prescription and Administration Record: The nephrology team are responsible for prescribing
the following medications specific to TPE as required by medical team.

Hydrocortisone 100 mgs IV

Piriton 10 mgs IV

Calcium gluconate 10% w/v 10 mls per L exchanged IV in 500mls NaCl 0.9% given as an
infusion.

10mls of 10% w/v of calcium gluconate should be added to the infusion if pre TPE corrected
calcium is <2.2mmol.

10mls of 10% w/v of calcium gluconate should be added to the infusion if SDP is being used
due to citrate content of SDP.

Calcium infusion rate should be increased if the patient experiences effects of hypocalcaemia
(tingling/numbness in extremities), if the effect of systemic hypocalcaemia does not resolve or
becomes more severe, 10mls of 10% w/v of calcium gluconate should be given stat via circuit.

4 mmols of KCl (potassium chloride) per litre volume exchange if there is evidence of
hypokalaemia

Heparin min 3000iu titrated to a max of 10000iu as a continuous infusion.

Heparin Free TPE will only be performed in emergency situations after direct consultation with
the Nephrology Consultant. If repeated sessions of heparin free TPE are required and clotting
occurs consider referral to other unit for citrate based anticoagulation (not currently available in
Beaumont)

Subsequent treatments: patients must be reviewed by their medical teams and liase with CNM
regarding subsequent treatment if required.

Patients positive for blood borne viruses should not have treatment in haemodialysis unit single
room only.

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6.6 PRE-TPE NURSING CARE ASSESSMENT

o Assess patients level of anxiety .Educate o Reduces anxiety and fears.

regarding TPE.

o Vascular access into the internal jugular or o Access is required to obtain access to the
femoral vein is necessary for TPE. If an patients blood.
internal jugular is inserted the patient must
have a chest x-ray which needs to be
reviewed by medical team.

o Documentation in the patients medical o Verifies that no complications have

notes must indicate that the vascular access resulted from insertion of catheter.
is positioned correctly.

o Assess vascular access for patency and signs o To ensure the patient's vascular access is
of infection. free from complications.

o Ensure aseptic technique is used when o Reduces the risk of complications.

handling the patients vascular access at all
times .

o Ensure emergency drugs are available and o In case of anaphylactic reactions.

in date.

o Ensure emergency trolley is available and o In case of severe anaphylactic reaction.

checked daily.

o Laboratory investigations prior to TPE. o Uraemia causes platelet dysfunction

U/E therefore increased risk of bleeding, also
indicates renal impairment. Hyperkalaemia
may cause arrhythmias.

o Coagulation screen o When albumin is used as the replacement

fluid, a depletion of all coagulation factors
occurs including fibrinogen and
antithrombin III. After one TPE treatment
the serum levels of these factors are
decreased by approximately 60%.

o Type and Screen o T/S for determining ABO status which is

required for ordering replacement fluids eg
FFP or 5% albumin.

o CPM CORRECTED CALCIUM o Citrate induced hypocalcaemia is a

common side effect of TPE if FFP is used
as replacement fluid and citrate as
anticoagulant. FFP is 15% citrate by
volume.

o Virology screen o Determines patients hepatitis status(see

nursing care guidelines for virology
screening).

o Specific laboratory analysis according to

disease process as appropriate.
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Guidelines for Therapeutic Plasma Exchange

6.7 POST TPE NURSING CARE ASSESSMENT

ACTION RATIONALE

Aseptic technique is used and vascular access
To observe for signs of vascular access infections
is observed at treatment completion. and related complications.

Monitor patients vital signs.
To identify alterations post treatment procedure

which would indicate complications eg
hypotension, reaction to replacement fluid,
hypocalcaemia.

Patients treatment procedures are documented
Effective communication skills are maintained
in medical and nursing notes. with in the multidisciplinary team.

Patient is stable prior to transfer back to ward.
Maintain a safe environment.

Liaise with ward nursing staff regarding
Effective communication skills are maintained
patients treatment. within the nursing staff.

Wear gloves, plastic apron & goggles prior to
Safe disposal of effluent and lines in prevention
disposing of TPE effluent bag and lines into of blood borne viruses.
Zulu bin. Zulu bin should be then sealed
following each treatment.

Replace any used emergency drugs.

Clean & disinfect prisma machine and

equipment used as per protocol. Teepol and
precept 1000ppm (1 tablet to 1 lt) and rinse
with plain H20 after 2-3 min. If contaminated
with blood clean & disinfect with solution of 7
tablet precept in 1lt H20 (10,000ppm)

6.8 COMPLICATIONS OF TPE

Vascular Access Haematoma & Pneumothorax (internal jugular), Retroperitoneal bleed (femoral),
Infection
Procedure Hypotension, Bleeding, Oedema, Loss of cellular
elements(platelets),Anaphylactic Reactions, Hypocalcaemia(citrate induced)
Anticoagulation Bleeding, Hypocalcaemia, Arrhythmias, Hypotension, Numbness and tingling
of extremities, Metabolic Alkalosis(with FFP)

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6.9 GUIDELINES FOR MANAGEMENT OF ANAPHYLACTIC REACTION.

SYSTEM SIGNS & SYMPTOMS

Cutaneous-Swelling (angio-oedema) Urticaria(hives), Redness(erythema), Itching(pruritis)
Respiratory Wheeze, Dyspnoea, Laryngeal obstruction (causing stridor),
Rhinitis, Hypoxia
Cardiovascular Hypotension., Tachycardia, Arrhythmias
Central Nervous System Confusion, Feeling of impending doom,, Altered levels of
consciousness
Gastrointestinal Nausea, Vomiting, Diarrhoea, Abdominal cramps, Metallic taste

In the case of severe anaphylactic reaction, please call the medical team.

7.0 DISTRIBUTION

A copy of the guideline will be circulated to the relevant areas by the Divisional Nurse Manager and
Consultants. The Clinical Nurse Manager in each area is responsible to ensure all staff access and read
the guideline. The guideline will also be available on the renal intranet webpage. The Consultant staff
are responsible to ensure that medical staff access and read the guideline.

8.0 FILING
A copy will be filed in the guideline and procedure book folder in each unit. The master copy will be
filed in the Divisional Nurse Managers office.

9.0 REVIEW
This guideline will be reviewed in two years, June 2013

10.0 SUPERSEDED/OBSOLETE DOCUMENTS

This is an updated version of GUIDELINES FOR THERAPEUTIC PLASMA EXCHANGE and
replaces all previous versions.

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11.0 Recommended Reading
1. American Nephrology Nurses' Association (1999) Standards and Guidelines of Clinical Practice for
Nephrology Nursing.

2. ASFA( American Society for Apheresis) (2007) Journal of Clinical Apheresis.2(3) Wiley-Liss.

3. An Bord Altranis (2000). Guidance to nurses and midwives on the development of guidelines
guidelines and protocols. Dublin.

4 Daugirdas, J. T., Blake, P. G., & Ing, T. D. (2001) Handbook of Dialysis. 3rd Edition. Boston: Little
Brown & Co.

5 Henderson, N. (1998) Anaphylaxis. Nursing Standard 12 (47):49 -55.

6 Kaplan, A. (1999) A Practical Guide to Therapeutic Plasma Exchange.

7 Kaplan, A.(1995) A. General Principles of Therapeutic Plasma Exchange. Seminar Dialysis.

8 Kaplan, A. (1992) Toward the Rational Prescription of Therapeutic Plasma Exchange. Seminar
Dialysis.

9 Mc Leod, B.C.(2005) Apheresis Principles and Practice. 2nd ed.AABB Press

10 Price, C.A. (1998) Contemporary Nephrology Nursing- American Nephrology Nurses' Association

11 Price, C.A. et al (1993) Anna Journal. 21(1)

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Appendix 1

PATIENT INFORMATION LEAFLET FOR

THERAPEUTIC PLASMA EXCHANGE
WHAT IS PLASMA?
Plasma consists mainly of water and carries the red blood cells, white blood cells and platelets around
the body. It also contains vitamins, minerals hormones and antibodies. It is yellow in colour.

WHAT IS THERAPEUTIC PLASMA EXCHANGE?

Therapeutic plasma exchange (TPE) is a procedure in which blood is passed through a filter which
separates out plasma from other components of blood. As the plasma is removed the disease substance
circulating in the blood is also removed and replaced a/or replacement solutions, either fresh frozen
plasma (FFP) and /or 5% human albumin with saline.

WHY IS IT NECESSARY?
Certain diseases cause the formation of substances called auto antibodies or abnormal proteins which
can attack the healthy cells and tissues and make you ill. Therapeutic plasma exchange (TPE) is a
procedure in which these auto antibodies or proteins which are in plasma are removed from the blood

HOW IS MY PLASMA REMOVED?

In order for TPE treatment to be carried out, access into a large vein must be achieved. This will be in
the form of (i) a catheter being inserted into a vein in the neck or groin or (ii) a surgically created
Arteriovenous Fistula in the arm. Blood is drawn from your access and passes through tubes which
connect to the machine and filter. The filter separates the red blood cells, white blood and platelets from
the plasma. A solution of fresh frozen plasma, 5% human albumin and normal saline or a combination of
all three, is then given into the blood stream as replacement fluid. The process occurs simultaneously so
that the amount of plasma being removed is being replaced at the same time.

WHO PERFORMS THE PROCEDURE?

This therapy is provided by the renal unit by a qualified staff nurse who has received additional training

HOW LONG DOES A PLASMA EXCHANGE TAKE?

Length of treatments will be based on the patients illness and their body weight and the physicians
prescription. Usually a treatment lasts between 2-4 hours. TPE is a life saving treatment.

HOW OFTEN DO I HAVE TO HAVE THERAPEUTIC PLASMA EXCHANGE?

The number of treatments will vary, according to your specific illness and your response rate. Your
doctor will decide on the number of treatments that you need to have.

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ARE THERE RISKS ASSOCIATED WITH THE TREATMENT?

There are certain risks and consequences associated with TPE as with any other medical procedure.
Possible complications include but are not limited to the following

(a) Vascular access problems such as infection, clotting, bleeding or lung collapse
(b) Blood borne diseases such as Hepatitis, or other infections such as MRSA
(c) Potential for air embolism in which excessive air enters the blood via the blood circuit
(d) Possibility of irregular heart beats, change in blood pressure
(e) Numbness and tingling of extremities
(f) Severe allergic reactions.

WHAT ABOUT BLOOD PRODUCT ADMINISTRATION?

Despite careful screening performed in accordance with applicable regulations, there are rare instances
of life-threatening infection resulting from blood product administration. Prior to the commencement of
TPE your blood will be tested for the Hepatitis B and C virus and HIV

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