TPE

TPE Training
Kanoo Kidney Center

Dammam – KSA
17th -19th November 2008
Dr. Michel Helmy

Product Manager ‐ IC
Middle East & East Africa
Agenda – Day 3
• TPE on PrismaFlex
• Practice (HANDS 0N)
• Demonstration on actual patient
© 2008 – Dr. Michel Helmy / IC Product Manager 2

TPE
with PrismaFlex®
PrismaFlex

What is Aphaeresis?

Aphaeresis
“A separation of whole blood into
its cellular components.
A selected component
is removed and the remaining
elements are recombined
and returned to the donor”.
American Society of Aphaeresis;

Principles of Apheresis Technology

Definitions:
“ Cytapheresis”
•Selective removal of any cellular component of whole blood, and
can be done with Centrifugal machinery.
For example:
“Erythrocytapheresis”:
•Removal of Erythrocytes (RBC).
•Used to treat life-threatening autoimmune hemolysis, and
parasitemia in Malaria.

Definitions:
“Thrombocytapheresis”:
•Removal of platelets for patients with myeloproliferative diseases
such as polycythemia vera, primary thrombocytemia and chronic
granulocytic leukemia, who are at risk of, or symptomatic of
thrombotic or hemorrhagic complications.

Definitions:
“Plasmapheresis”: “(TPE)”
•The procedures in which the patient’s plasma is separated and

removed from the whole blood.
•The removed plasma is replaced 1:1 ratio with a replacement

solution i.e. Albumin or FFP.
•To treat autoimmune conditions such as Myasthenia Gravis, TTP

and Guillian-Barre’ Syndrome.

-Packed RBCs being the heaviest blood
component with a specific gravity of 1.75
are separated along the outside wall of
the spinning channel. The “Buffy coat”
in the center of the channel consists of
WBCs, Platelets, and Stem cells.
Platelets have a specific gravity of 1.04.
Plasma is the lightest blood component
with a specific gravity of 1.025.

Therapeutic Plasma Exchange
often the therapy of REMOVES:

choice because its • Immune complexes
• Immunoglobulins
capabilities of removing (IgG, IgM, IgA)
very large molecules to • Cholesterol
treat various disease • Albumin
• Fibrinogen
conditions. • Urea, Creatinin
• Electrolytes
• Plasma protein bound
10
Common Diseases treated with TPE
Good pasture’s syndrome

•Inflammatory mediators
Poisons/drug OD
•Dilantin, mushrooms
TTP
•Replacement of plasma deficiencies
Deficiency of LDL
•Familial Hypercholesterolemia

Indications of TPE:
Emergency Indications:
•Microagiopathic Thrombocytopenia (TTP / HUS).
•Respiratory Failure in Guillian-Barre’ Syndrome or Myasthenia
Gravis.
•Acute poisoning for certain mushrooms or with other strongly
protein bound poisons.
•Hyperviscosity syndrome with s&s suggesting impending stroke or
loss of vision.
•Anti – GMB disease & / or pulmonary hemorrhage in Good
Pasture’s Syndrome.

Indications of TPE:
Primary Indications:
•Good Pasture’s Syndrome
•TTP / HUS
•Cryoglobulinemia
•Hyperviscosity Syndrome
•Familial Hypercholesterolemia
•Myasthenic crisis
•SLE cerebritis (lupus)
•Myeloma cast nephropathy
•Coagulation factors inhibitor
•Systemic vasculitis

Mechanisms of action for TPE:
Purpose of TPE Target Mediator to be Disease condition
removed Example:
Removal of abnormal • Antibody • Myasthenia Gravis

circulating factors •Monoclonal Protein • Myeloma Protein
(found in Plasma) • Circulating Immune • Cryoglobulinemia
complexes • TTP / HUS
• Toxic factor
Replenishment of • None • TTP

specific plasma factors
(Immunoglobulin,
clotting factors)

TPE Categorization…
Category I: Conditions for which therapeutic hemapheresis is

standard and acceptable treatment as primary or important
secondary treatment.
Category II: Conditions for which sufficient data has shown

hemapheresis effective in conjunction with other modalities.

Category III: Conditions for which there is insufficient evidence to

evaluate efficacy and benefit:risk ratio. TPE might be used if other
tx’s have failed or experimentally.

Category IV: Controlled trials have shown no therapeutic efficacy.

TPE is discouraged as a treatment choice.
Category V: Pending further investigation by committee.

Mechanisms of action for TPE:
Purpose of TPE Target Mediator to be Disease condition

removed Example:
Other effects on the • Removal of Inflammatory • Sepsis
Immune system Mediators (Cytokines,
complement)

Principles of Treatment
1. Therapy should almost always include immuno – suppression (i.e.

Cortico steroid treatment).
- this will reduce the rate of resynthesis of pathologic antibodies

production.
2. Diseases that respond to TPE should be treated early to halt

inflammatory response that often contributes to the disease
progression.

3. Knowledge of the Kinetics of immunoglobulin removal;
a. Immunoglobulins have a long half life;

- 21 days for IgG
- 5 days for IgM

3. Knowledge of the Kinetics of immunoglobulin removal;
b. Immunoglobulins have substantial extravascular distribution.
The extent of intravascular vs. extravascular distribution will
determine how effectively they can be removed in the course of
single TPE session.
Example:
Extravascular Distribution of IgG = 50%
IgM = 20%
Therefore; depletion of IgM occurs more quickly than that of IgG.

Technological Application to TPE
¾Centrifugation
¾Plasmafiltration

Centrifugation Technique

Technological Application to TPE:
Centrifugation Technique:

Membrane Filtration
A plasma membrane separator

device is similar
to a hemodialyzer in appearances.
Both contain hollow fibers, but the

membrane properties are
significantly different.
• Dialyzer removes elements up
to 50,000 Daltons
• Plasma membrane removes
plasma and all dissolved
• components up to 3 million
Daltons

TPE
Return pressure Air detector
Syringe pump Blood pump Return Clamp

Patient
Plasma filter
Access pressure
Filter pressure
BLD
Plasma Replacement Effluent Infusion or Anticoagulant

Size of molecules cleared by CRRT
Molecular weights
Mode of removal
Nothing above 50.000 is cleared
Large Molecules
Convection or adsorbtion
Middle Molecules
Convection better than
diffusion
Small Molecules
Diffusion is better than
convection

CRRT vs. TPE Goals of Therapy:
CRRT TPE (Plasmafiltation)
• Electrolyte, fluid and pH balance • Removal of plasma containing large

proteins and immuno globulins.
• Removal of excess fluid and waste by- • Maintain euvolemic state by replacing
products (urea, creatinine) 1:1 plasma removed and replacement
solution.

CRRT vs. TPE Goals of Therapy:
CRRT TPE (Plasmafiltation)
• Hemofilter • Plasmafilter
• Central venous access required • Central venous required

Anatomy of Plasmafilter

Filter Specification
Specification PF 2000N (TPE) M100 CRRT
• Molecular Wt. Cut-off 3 million Daltons 30,000 Daltons
• Fiber Material Polypropylene Acrylonitrile (AN69)
• Hollow Fibers 3,000 6,000
• Membrane Semi-permeable Semi-permeable
• Sterilization ETO ETO
• Effective Surface Area 0.35 m2 0.90 m2
• Maximum Pore size 0.5 um <0.01 um
• Total volume of circuit 88 ml 107 ml
• Circuitry differences • No dialysate line • Dialysate line in place
• Replacement line given • Replacement line
post-filter usually given pre-filter
• Extra fluid line attached but can be post or both
to access line.

Filter Specification
Pre-connected filter membrane used in both CRRT & TPE. The major
differences with the TPE filter set is that it has no dialysate line connected
& replacement is always given post-filter.

Principles of Plasmafiltration:
Filtration
Convection
Sieving Coefficient

Filtration:
Movement of fluid across the
semi-permeable membrane
driven by pressure gradient. Plasma Volume
Reduction

Convection:
Movement of solutes along with water flow.
“ Solvent drag or Solute drag”
•Plasma is the solvent

•Solutes; electrolytes, amino acids, vitamins, albumin and
immunoglobulin are dragged along with the plasma into the drain.
•The more plasma being removed, the more solute loss will occur.

Sieving Coefficient
•Solute removal mainly depends on the S.C.
•Ratio of solute between the ultra filtrate (Effluent) and the plasma.
• S.C. of 1.0; means a complete passage of solutes from the

plasma into the effluent bag.

Sieving Coefficient:
Solute PF 2000 N (SC) M100 (SC)
• Albumin 0. 97 <0.01
• Total Proteins 0.92 (>) <0.02
• Potassium 1.0 1.0
• Creatinine, Urea 1.0 1.0
• Bicarbonate 1.0 1.0

Sieving Coefficient:
Important Point:
• TPE performed with a CRRT filter would be ineffective.
• CRRT performed with dedicated TPE filter would be life endangering
due to constant albumin loss without replacement.

Schematic Set up for TPE Circuitry:

Components of Therapy
•Calculating the Plasma Volume to be removed.

•Replacement Solution
•Anticoagulation
•Vascular Access
•Warming Device

Estimated Plasma Volume (PV) to exchange:
• Use nomogram and equations using height, weight

and hematocrit in the literature;
• Useful Rule of thumb is to consider Plasma Volume

(PV) to be approximately: 40 ml/kg of body weight.
Example:
70 kg patient, the PV would be;
70 kg x 40 ml/Kg = 2800 ml or 3000 ml.

Estimated Plasma Volume (PV) to exchange:
Physician’s Order;
1.0 or 1.5 Plasma Volume to be Exchanged
For a 70 Kg patient;
A 1.0 or 100% PV exchange would be 3000 ml.

A 1.5 or 150% PV exchange would be 4500 ml.
Ensure that you follow the physician’s order for PV to be exchanged.

Replacement Solutions
Two Basic types of Replacement Fluids;
•Colloids
•Crystalloids

Colloids;
Albumin 5%
•Most commonly used replacement solution used in TPE.

•Maintains the patient’s colloid oncotic pressure.
•Best to check coagulation parameters; such as PT/PTT before the
therapy.

Colloids;
Fresh Frozen Plasma
•High cost, low availability and possible risk of Hepatitis and HIV,
this limits the use of FFP.
Important note:
•14% of FFP’s volume content is Citrate. If citrate anticoagulation is used,
infusion rate should be reduced.
•An anti-histamine is often used to prevent Histamine – mediated

responses that maybe associated with Plasma administration.

Crystalloid;
Normal Saline:
•Usual treatment of Hypotension during TPE.
•Successful combination with Albumin 5%
•One third of Plasma Volume will be NSS.
•Remaining Plasma Volume will be 5% Albumin.
•Patient’s serum albumin level must be monitored and kept at >
3.5 g/dl when using this combination.

Vascular Access
• Good working Catheter is

best required for TPE.
• Peripheral IV accesses are

not used for TPE / CRRT.
• Most common cause of

pressure alarms are due to
the vascular accesses.

Other blood purification
techniques
Hemoperfusion, New trends

Hemoperfusion

Hemoperfusion
Return pressure Air detector
Syringe pump Blood pump Return Clamp

Patient
Cartridge
Cartridge pressure Access pressure
Anticoagulant

New trends
Related to sepsis
• Removal of mediators
• Timing
• Feasibility
Therapy options
• High volume
• High cut-off
• Adsorption

WHY Sepsis
• Most important health problem

• Interaction between SIRS and infection = SEPSIS
• Human sepsis is characterized by a systemic action of inflammatory
cytokines TNF & IL6 which if persistent causes death
• Sepsis = balance between pro- and anti-inflammatory cytokines
• The objective of an extracorporeal treatment is to remove the mediators that
are involved in the cascade

Further role in Sepsis
• A protective shield against peak of circulating mediators

• A therapy of SIRS as a causative condition for MODS
• A bridge towards native Renal/Liver function recovery
• A protective therapy against further ischemic insults
• A therapy with positive impact on other organ function
• Non specific removal
• Clinical safety: hypothermia, nutrition, vascular access, indications,…

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TPE Training

Kanoo Kidney Center

Dr. Michel Helmy

• Practice (HANDS 0N)

• Demonstration on actual patient

© 2008 – Dr. Michel Helmy / IC Product Manager 2

© 2008 – Dr. Michel Helmy / IC Product Manager 3

© 2008 – Dr. Michel Helmy / IC Product Manager 4

American Society of Aphaeresis;

© 2008 – Dr. Michel Helmy / IC Product Manager 5

© 2008 – Dr. Michel Helmy / IC Product Manager 6

© 2008 – Dr. Michel Helmy / IC Product Manager 7

•The procedures in which the patient’s plasma is separated and

•The removed plasma is replaced 1:1 ratio with a replacement

•To treat autoimmune conditions such as Myasthenia Gravis, TTP

© 2008 – Dr. Michel Helmy / IC Product Manager 8

© 2008 – Dr. Michel Helmy / IC Product Manager 9

often the therapy of REMOVES:

Good pasture’s syndrome

© 2008 – Dr. Michel Helmy / IC Product Manager 11

© 2008 – Dr. Michel Helmy / IC Product Manager 12

© 2008 – Dr. Michel Helmy / IC Product Manager 13

Removal of abnormal • Antibody • Myasthenia Gravis

Replenishment of • None • TTP

© 2008 – Dr. Michel Helmy / IC Product Manager 14

Category I: Conditions for which therapeutic hemapheresis is

Category II: Conditions for which sufficient data has shown

© 2008 – Dr. Michel Helmy / IC Product Manager 15

Category III: Conditions for which there is insufficient evidence to

© 2008 – Dr. Michel Helmy / IC Product Manager 16

Category IV: Controlled trials have shown no therapeutic efficacy.

Category V: Pending further investigation by committee.

© 2008 – Dr. Michel Helmy / IC Product Manager 17

Purpose of TPE Target Mediator to be Disease condition

© 2008 – Dr. Michel Helmy / IC Product Manager 18

1. Therapy should almost always include immuno – suppression (i.e.

- this will reduce the rate of resynthesis of pathologic antibodies

2. Diseases that respond to TPE should be treated early to halt

© 2008 – Dr. Michel Helmy / IC Product Manager 19

3. Knowledge of the Kinetics of immunoglobulin removal;

a. Immunoglobulins have a long half life;

© 2008 – Dr. Michel Helmy / IC Product Manager 20

© 2008 – Dr. Michel Helmy / IC Product Manager 21

© 2008 – Dr. Michel Helmy / IC Product Manager 22

© 2008 – Dr. Michel Helmy / IC Product Manager 23

© 2008 – Dr. Michel Helmy / IC Product Manager 24

A plasma membrane separator

Both contain hollow fibers, but the

© 2008 – Dr. Michel Helmy / IC Product Manager 25

Syringe pump Blood pump Return Clamp

Plasma Replacement Effluent Infusion or Anticoagulant

© 2008 – Dr. Michel Helmy / IC Product Manager 26

Nothing above 50.000 is cleared

© 2008 – Dr. Michel Helmy / IC Product Manager 27

CRRT TPE (Plasmafiltation)

• Electrolyte, fluid and pH balance • Removal of plasma containing large

© 2008 – Dr. Michel Helmy / IC Product Manager 28

• Central venous access required • Central venous required

© 2008 – Dr. Michel Helmy / IC Product Manager 29

© 2008 – Dr. Michel Helmy / IC Product Manager 30

© 2008 – Dr. Michel Helmy / IC Product Manager 31

© 2008 – Dr. Michel Helmy / IC Product Manager 32

© 2008 – Dr. Michel Helmy / IC Product Manager 33

© 2008 – Dr. Michel Helmy / IC Product Manager 34