3. Rationale For Plasmapheresis
TPE is an extracorporeal blood purification technique
designed for the removal of large-molecular weight
(>15000 D) substances.
Examples
Pathogenic Autoantibodies,
Immune Complexes
Complements
Cryoglobulins,
Myeloma Light Chains,
Endotoxin,
Fibrinogen And Cytokines
Cholesterol-containing Lipoproteins.
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4. Possible Mechanisms of Action of TPE
Removal of Abnormal Circulating Factor
Antibody (anti-GBM disease,MG, GBS)
Monoclonal Protein (Waldenströmm Macroglobulinemia,
Myeloma Protein)
Circulating Immune Complexes (Cryoglobulinemia, SLE)
Alloantibody (Rh Alloimmunization In Pregnancy)
Toxins
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5. Possible Mechanisms of Action of TPE
Replenishment of Specific Plasma Factor
TTP
Other Effects on the Immune System
Improvement in function of RES
Removal of inflammatory mediators
Shift in antibody-to-antigen ratio
Resulting in more soluble forms of immune complexes
Effects on the cellular immune system
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6. Ideal Target Molecule Characteristic
Identified Etiologic Agent Or Toxic Substance
High Molecular Mass (>15,000 D)
Slow Rate Of Formation
Low Turnover
Low Volume Of Distribution
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7. Pharmacokinetics Of Ig Removal
Plasma Half-life
Extravascular Distribution And Equilibration Rate
The Macromolecule Reduction Ratio (MRR) and Ve/Vp
Reaccumulation
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8. Plasma Half-life
Immunoglobulins have relatively long half-lives, approaching 21
days for IgG and 5 days for IgM.
Because of the relatively long plasma half-lives of the
immunoglobulins, the use of immunosuppressive agents that
decrease their production rate cannot be expected to lower the
plasma levels of a pathogenic autoantibody for at least several
weeks, even if production is completely blocked.
This is the basic rationale for their removal by extracorporeal
means.
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9. Extravascular Distribution
And Equilibration Rate
Substance Molecular
weight (D)
% IV Half life
(days)
S. Conc
(mg/dl)
Albumin 69,000 40 19 3500 - 4500
IgG 1,80,000 45 21 640 - 1430
IgA 1,50,000 50 6 30 – 300
IgM 9,00,000 80 5 60 – 350
LDL-C 13,00,000 100 3-5 140 - 200
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10. Effectiveness Of Extracorporeal Therapies In
Relationship To The Size Of Target Substances
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Kilo Dalton
Clin J Am Soc Nephrol 9: 181–190, 2014
11. The MRR and Ve/Vp
Portion of Plasma
Volumea Exchanged
(Ve/Vp)
Volume Exchanged
(Ve, mL)
Immunoglobulin or
Other Substance
Removed (MRR, %)
0.5 1400 39
1 2800 63
1.5 4200 78
2 5600 86
2.5 7000 92
3 8400 95
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12. Relationship Between Reduction In A Plasma Substance As A
Function Of The Exchanged Plasma Volume
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63%
86%
95%
Daugirdas : Handbook Of Dialysis, 5th edition.
13. 3/4/202013
Progressive decrease in immunoglobulin (IgG) levels after 3
consecutive TPE treatments equaling 1 plasma volume each
Clin J Am Soc Nephrol 9: 181–190, 2014
14. Reaccumulation
Two Sources:
Redistribution
Further Synthesis.
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15. Pharmacokinetic Basis For TPE
Prescriptions
A rational approach to prescribing TPE is generally to
recommend 1 – 1.5 plasma volume exchange daily or every
other day, depending on the disease process, to allow time
for adequate redistribution of macromolecules.
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16. Plasma Extraction Ratio
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To exchange 1 plasma volume (PV), which is 3 litres of
plasma, using cTPE and assuming 80% plasma extraction
ratio, 3.75 litres of blood must be processed.
At a typical cTPE blood flow rate of 50 ml/minute, it would
take 75 minutes to achieve this separation.
Casey N. Gashti, Seminars in Dialysis—2016
17. Plasma Extraction Ratio
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A similar 1 PV exchange (3 litres) using mTPE will require
10 litres of blood processing.
At a blood flow rate of 150 ml/minute, which is commonly
seen in mTPE, it would take 67 minutes to achieve this goal.
Casey N. Gashti, Seminars in Dialysis—2016
18. Estimation Of Plasma Volume
A useful rule of thumb is to consider plasma volume to be
approximately 35–40 mL/kg of lean body weight.
Lower number (35 mL/kg) applicable to patients with normal
Hct values
40 mL/kg applicable to patients with Hct values that are less
than normal.
Kaplan's Equation :
EPV = 0.065 ×BW (kg)× (1- Haematocrit)
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20. Technical Considerations
Membrane plasma separation (MPS) must be performed at low
TMP (<500 mm Hg) to avoid hemolysis.
With hollow-fiber devices, the blood flow rate should exceed 50
mL/min to avoid clotting.
The ideal blood flow rate (Qb) is usually 100–150 mL/min.
When the blood flow rate is 100 mL/min, a plasma removal rate
of 30–50 mL/min can be expected.
Thus, the average time required to perform a typical membrane
filtration (Ve = 2,800 mL) is <2 hours (40 mL/min × 60 minutes
= 2,400 mL/hr).
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22. Characterstics
Characterstics cTPE mTPE
Mechanism Centrifugal Force Capillary membrane filter
Blood flow (ml/min) 10-150 150
Plasma extraction (%) 80 30
Plasma removal (ml/min) Variable 30
Anticoagulation Citrate Heparin
Separation Specific Gravity Size
Blood volume in circuit 180 ml approx 125 ml approx
Molecular wt cut off(D) N/A 3 million
Sterilisation Gamma irradiation/ EO Ethylene oxide
Fluid replacement Albumin / FFP Albumin / FFP
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Clin J Am Soc Nephrol 9: 181–190, 2014
23. Membrane
Plasma
Separation
Advantages Disadvantages
Faster and smaller
equipment
Removal of substances limited
by sieving coefficient of
membrane
No citrate requirements Reduced efficiency in
hyperviscosity syndromes and
cryoglobulinemia
Can be adapted for cascade
filtration
Unable to perform cytapheresis
Requires high blood flows,
central venous access
Requires heparin
anticoagulation, limiting use in
bleeding disorders
Centrifugal
Apheresis
Capable of performing
cytapheresis
Large and heavy equipment
No heparin requirement Requires citrate anticoagulation
More efficient removal of all
plasma components
Loss of platelets
3/4/202023Clin J Am Soc Nephrol 9: 181–190, 2014
24. RBC : Outer Most
Plasma : Inner Most
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26. Blood cells are
not allowed to
pass through
the pores of the
filter, while
plasma
constituents
pass through.
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Daugirdas : Handbook Of Dialysis, 5th edition.
27. Vascular Access
A. Antecubital veins:
1. Ideal for low-flow treatments
2. Increasingly difficult to use after multiple punctures
B. Temporary vascular catheters:
1. Femoral vein cannulation
2. Subclavian and internal jugular catheters
3. Tunneled jugular venous catheters
C. Permanent arteriovenous access: Preferred if treatments
are to be repeated regularly (hyperlipidemia).
1. Primary arteriovenous fistula
2. Arteriovenous graft
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Therapeutic Plasma Exchange: Core Curriculum 2008
28. Anticoagulation
1. Heparin
2. Citrate
Anticoagulation solution for most TPE procedures.
Two standard formulations
Formula A (ACD-A) : 2.2 g/dL of sodium citrate and 0.73 g/dL of
citric acid.
Formula B (ACD-B) : 1.32 g/dL of sodium citrate and 0.44 g/dL of
citric acid.
ACD-A is used for all continuous-flow centrifugal devices.
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Therapeutic Plasma Exchange: Core Curriculum 2008
29. Replacement Solution
Solution Advantages Disadvantages
Albumin
No risk of hepatitis Expensive
Stored at room temp. No coagulation factors
Allergic reactions are rare No immunoglobulins
No concern about ABO
blood group
Depletes inflammation
mediators
FFP
Coagulation factors Risk of hepatitis, HIV
transmission
Immunoglobulins Allergic reactions
“Beneficial” factors Must be thawed
Must be ABO-compatible
Citrate load
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Therapeutic Plasma Exchange: Core Curriculum 2008
30. Replacement Solution
There is a small but measurable incidence of transmission
via FFP of hepatitis B (0.0005% per unit), hepatitis C
(0.03% per unit), and HIV (0.0004% per unit).
Five percent albumin solution at a concentration of 5 g/dL
(50 g/L) in saline with 130–160 mmol of sodium chloride
per liter can be replaced in a volume equal to that of the
removed plasma.
The amount of fluid replacement : 85 – 100%
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Therapeutic Plasma Exchange: Core Curriculum 2008
31. Complications
Range from 4% to 25%, with an average of 10%.
Minimal reactions occur in about 5% of treatments and are
characterized by urticaria, paresthesias, nausea, dizziness, and
leg cramps.
Moderate reactions (5%–10% of treatments) include
hypotension, chest pain, and ventricular ectopy. All are usually
brief and without sequelae.
Severe events occur in <3% of treatments and are mainly related
to anaphylactoid reactions associated with FFP administration.
The estimated mortality rate associated with TPE is 3–6 per
10,000 procedures.
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Therapeutic Plasma Exchange: Core Curriculum 2008
34. Hypocalcemia
Symptoms : perioral and distal extremity paresthesias.
Cause : FFP (14% Citrate)
ECG : QTc Prolongation
iCa+2 by 35% : QTc by 0.09 sec.
Post TPE :
iCa+2 by 18%
iPTH by 280%
Treatment
Ca Gluconate 10ml 10%
Citrate infusion rate : 1 – 1.8 mg/kg/min
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Silberstein et al: Calcium homeostasis during TPE. Transfusion 26:151-155, 1986
35. Coagulation Abnormalities
When albumin is used as the replacement fluid changes in
coagulation factors immediately following a single plasma
exchange :
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Fibrinogen 20%
Prothrombin 40%
Factor 5 42%
Factor 7 47%
Factor 8 50%
Factor 9 57%
Factor 10 32%
AT 3 42%
Wood L J Clin Apher 3:124-128, 1986
36. Coagulation Abnormalities
Recovery Is Biphasic
First 4 Hrs : Rapid Initial Increase
4 – 24 Hrs ; Slower Increase
After 24 Hrs : Fibrinogen : 50%, AT3 : 85%
48 – 72 Hrs : Complete Recovery
On Day Following TPE : Prothrombin : 75%
aPTT & TT : WNL 4 hrs after TPE
Treatment : 2 Units (400-500 ml) FFP towards end of TPE.
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Wood L, Jacobs P: The effect of serial therapeutic plasmapheresis on platelet count, coagulation factors
plasma immunoglobulin and complement levels. J Clin Apher 3:124-128, 1986
37. Coagulation Abnormalities
Thrombocytopenia
cPLEX : 50% decrease
mPLEX : 15 % decrease
Cause :
Discarded Plasma
Filter Thrombosis
Haematocrit :
Decrease by 10%
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Wood L, Jacobs P: The effect of serial therapeutic plasmapheresis on platelet count, coagulation factors
plasma immunoglobulin and complement levels. J Clin Apher 3:124-128, 1986
38. Infection
When albumin is used as the replacement fluid, removal of
immunoglobulins and complements Infections.
One plasma volume exchange will result in a
60% reduction in serum Ig levels
Net 20% reduction in total body Ig stores.
Although concentrations of C3 and C4 may be depleted by a series of
daily treatments, these levels rebound within several days.
CH50 is unaffected by repetitive exchanges.
Therapeutic plasma exchange with FFP replacement would not be
expected to deplete immunoglobulin or complement levels.
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Schreiber et al: N Engl J Med 334:1685- 1690, 1996
39. Infection
Risk of viral transmission during plasma exchange is
directly related to replacement with FFP.
Albumin and immunoglobulin preparations are treated
with heat, inactivating hepatitis and HIV.
The current incidence of transfusion-acquired
Hepatitis B is approximately 0.0005%
Hepatitis C is 0.03%
HIV is approximately 0.0004% per unit transfused.
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Schreiber et al: N Engl J Med 334:1685- 1690, 1996
40. Reactions to FFP and Albumin
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The incidence of adverse reactions in the albumin
replacement group was 1.4%, compared with 20% in the
group receiving FFP.
These were anaphylactoid in nature and were characterized
by fever, rigors, urticaria, wheezing, and hypotension.
The major causes of death were cardiovascular, respiratory,
and anaphylactic.
Apter AJ, J Allergy Clin Immunol 90:119-124, 1992
41. Reasons For Anaphylactoid Reactions
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The presence of anti-immunoglobulin A (IgA) antibodies in a
patient who is IgA deficient and receiving IgA-containing fluids
(ie, FFP, immunoglobulins),
Contamination with bacteria and bacterial endotoxin or
pyrogens,
The presence of a prekallikrein activator and bradykinin,
The formation of antibodies to polymerized albumin created by
heat treatment or stabilization with sodium caprylate.
Apter AJ, J Allergy Clin Immunol 90:119-124, 1992
42. Causes for Hypotension During TPE
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Delayed or inadequate volume replacement
Vasovagal episodes
Hypo-oncotic fluid replacement: 3.5% albumin solutions
Anaphylaxis:
Reactions to plasma components in replacement fluids
Anti-IgA antibodies (IgA-deficient patient)
Endotoxin-contaminated replacement fluid
Reactions to bioincompatible membranes
Sensitivity to ethylene oxide
Device-related: Prosorba protein A column
Cardiac arrhythmia
Citrate-induced hypocalcemia
Hypokalemic related (especially in patients on digitalis therapy)
Therapeutic Plasma Exchange: Core Curriculum 2008
43. Causes for Hypotension During TPE
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Bradykinnin reactions (cf reactions to ACE inhibitors)
Hemorrhage
Associated with primary disease (ITP, factor VIII inhibitors)
Associated with heparin anticoagulation
Associated with vascular access
External
Internal
“Depletion” coagulopathy
Cardiovascular collapse
Pulmonary embolus
Disease-related hypotension
Guillain-Barre syndrome (autonomic dysfunction)
Waldenstrom macroglobulinemia (rapid decrease in plasma volume)
Therapeutic Plasma Exchange: Core Curriculum 2008
44. Vitamins
Immediately postpheresis, decreases in blood
concentrations of vitamins B 12, B6, A, C, and E and beta-
carotene (24% to 48% reduction) have been noted;
however, these rebound to pretreatment levels within 24
hours.
Folate, thiamine, nicotinate, biotin, riboflavin, and
pantothenate are not significantly altered by plasma
exchange.
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Reddi A. JAmColl Nutr 6:485-489, 1987
46. Drug Removal
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1. Not significantly removed by
TPE:
i. Prednisone
ii. Prednisolone
2. Minimal removal:
i. Cyclophosphamide
ii. Azathioprine
iii. Aminoglycosides
iv. Tobramycin
v. Digoxin (removal of
digibindbound
drug may be enhanced
in patients with renal failure)
vi. Digitoxin
vii. Vancomycin
3. Posttreatment supplement
may be necessary:
i. Phenytoin
ii. Acetylsalicylic acid
iii. Propranolol
iv. Thyroxine: 25% in the
intravascular compartment
99% protein bound.
Jones JV: The effect of plasmapheresis on therapeutic drugs. Dial Transplant 14:225-226, 1985
47. Management Strategies to Avoid Complications
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Hypocalcemia Prophylactic calcium administration (10 mL of
10% Ca gluconate infused over 10 min)
Hemorrhage Partial FFP replacement in patients at high risk for hemorrhage
Sensitivity to
replacement fluids
Consider diagnostic evaluation (ie, anti-lgA antibody, anti-
ethylene oxide antibody,
anti-human serum albumin antibody, endotoxin assay, and
bacterial cultures of replacement fluid, etc)
Premedication regimen for sensitized individuals:
(1) Prednisone 50 mg orally 13 hr, 7 hr, and 1 hr pretreatment;
(2) Diphenhydramine 50 mg orally 1 hr pretreatment,
(3) ephedrine 25 mg orally 1 hr pretreatment and before pheresis.
Thrombocytopenia Consider membrane plasma separation
Volume-related
hypotension
Consider continuous flow separation with matched input and
output
Consider increasing protein concentration of replacement fluid
Infection post pheresis Infusion of IVIg(100 to 400 mg/kg)
Hypokalemia Ensure a potassium concentration of 4 mmol/L in the replacement
solution
Hypothermia Warm replacement fluids
Therapeutic Plasma Exchange: Core Curriculum 2008
50. ASFA Categories
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1 Diseases in which apheresis is a standard and widely
accepted method of treatment
2 Diseases in which apheresis is accepted as a supplementary or
secondary method of treatment.
3 Diseases in which apheresis is employed as a treatment
method, but its effectiveness is not sufficiently documented
4 Diseases in which apheresis was documented to be completely
ineffective, but the treatment may be conducted as a part of
clinical trial and requires explicit consent from the patient.
Blood Purif 2016;41:1–10
51. 3 Quality Of Evidence Grades
A – High Quality Evidence – is based upon the results of
sufficiently large prospective, randomized clinical studies.
B – Moderate Quality Evidence – is based upon the results
of randomized clinical trials of lower quality or high quality
observational studies.
C – Low Quality Evidence – is based upon properl
conducted observational studies or – very low quality
evidence series of cases or expert opinions.
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Blood Purif 2016;41:1–10
55. ASFA category I renal indications for TPE
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Kidney Disease Indication
ANCA-associated RPGN Dialysis Dependence
DAH
Anti-GBM disease DAH
Dialysis Independence
Cryoglobulinemia Symptomatic, severe
FSGS Post Tx Recurrence
Atypical HUS Factor H antibodies
Kidney transplant ABMR
Desensitization
TTP
Clin J Am Soc Nephrol 9: 181–190, 2014
56. Other Apheresis Techniques
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Technique Method Type of pathogen
removed
Double
filtration
Centrifugation or filtration
method of plasma separation
complemented with refiltration,
requires supplemental fluids
IC, auto Ab,other
pathological proteins
Cryofiltrati
on
Centrifugation or filtration
method of plasma separation
complemented with re-filtration
and cooling, does not require
supplemental fluids.
Cryoproteins
Plasma
adsorption
Centrifugation or filtration
method of plasma separation,
adsorption on phenylalanine,
tryptophan or polymyxin B-filled
columns
Anti-DNA antibodies,
myeloperoxidase,
ANCA, IgG , lupus-
like anticoagulant,
endotoxins,
cytokines, CRP, IC,
TNFα, VEGF, MIP
57. Other Apheresis Techniques
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Technique Method Type of pathogen
removed
Immunoadsorption Protein A, anti-IgG Fc
antibodies adsorption
(i.e. dextran sulfate)
Antibodies, protein
complexes
LDL apheresis Chemical compounds
adsorption
(tryptophan,
polyacrylate)
LDL lipoprotein
Cytapheresis Centrifugation
method of plasma
separation
CD8 lymphocytes,
CD4, activated
platelets,
granulocytes
58. Anti-GBM) Antibody–Mediated Disease
(Goodpasture syndrome)
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Treatment strategy:
1. Early initiation of TPE is essential to avoid ESRD
2. Initial prescription is 14 daily 4-L exchanges
3. Continued apheresis may be required if antibody titers remain
increased
4. Steroids, cyclophosphamide, or azathioprine are added to decrease
production of anti-GBM antibody and minimize the inflammatory
response.
Therapeutic Plasma Exchange: Core Curriculum 2008
59. RPGN; Not Associated With
Anti-GBM Antibody
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Therapeutic Plasma Exchange: Core Curriculum 2008
60. Renal Failure in Multiple Myeloma
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1. Successful TPE prescription is 3 to 4 L of plasma
exchanged on 5 consecutive days.
2. Well-established (chronic) renal failure considered to be
caused by cast nephropathy may respond less
dramatically.
3. Newly available highly permeable hemofilter membranes
may allow for light chain removal without significant
albumin loss (Hutchison et al).
Therapeutic Plasma Exchange: Core Curriculum 2008
61. IgA Nephropathy and HSP
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Case reports and small clinical series suggest a possible
beneficial effect of TPE in the treatment of IgA-associated
RPGN.
Therapeutic Plasma Exchange: Core Curriculum 2008
62. Cryoglobulinemia
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A reasonable TPE prescription is to exchange 1 plasma
volume 3 times weekly for 2 to 3 weeks.
An average of 13 treatments may be required to induce
clinical improvement (range, 4 to 39).
The replacement fluid can be 5% albumin, which must
be warmed to prevent precipitation of circulating
cryoglobulins.
Therapeutic Plasma Exchange: Core Curriculum 2008
63. TTP
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A large randomized controlled study found 78%
survival with TPE and FFP replacement compared
with 50% survival with FFP infusions alone (Rock et
al).
TPE with FFP replacement is the treatment of choice
for TTP and is considered standard of care.
Therapeutic Plasma Exchange: Core Curriculum 2008
64. TTP
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Treatments are performed daily until the platelet count is
normalized and hemolysis has largely ceased
(normalization of LDH).
Exchanged volumes should be at least 1 plasma volume.
Some experts recommend 1.5 plasma volume exchanges for
the first week.
Therapeutic Plasma Exchange: Core Curriculum 2008
65. HUS in Adults
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Prognosis in adults is poor:
i. Mortality between 25% and 50%
ii. ESRD in 40%
Although treatment success depends on the cause,
HUS in adults is often treated with TPE as with TTP.
Therapeutic Plasma Exchange: Core Curriculum 2008
66. HUS in Children
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TPE may be beneficial in children:
1. Without a diarrheal prodrome
2. Older than 5 years
3. With significant central nervous system involvement
Therapeutic Plasma Exchange: Core Curriculum 2008
67. Systemic Lupus Erythematosus
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RCT could not document systematic benefit of TPE when
added to standard immunosuppressive therapy.
TPE may still be useful in certain special situations:
Pregnancy, when cytotoxic agents are undesirable.
Lupus-associated TTP .
Lupus anticoagulant (LA)/antiphospholipid antibody
syndrome.
Levis EJ, N Engl J Med 326:1373-1379, 1992
68. Scleroderma
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TPE may be useful in rare coexistence of scleroderma
and ANCA-positive or antinuclear antibody (ANA)-
positive renal disease.
J Rheumatol 21:864-870, 1994
69. FSGS : Recurrence Post Transplantation
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15% to 55% of patients with ESRD secondary to FSGS have rapid
recurrence of proteinuria after renal transplantation.
Some patients with early recurrence of proteinuria have a
circulating 30- to 50,000-d protein capable of increasing
glomerular permeability to albumin.
Standard TPE and immunoadsorption have been successful in
decreasing the level of proteinuria.
The addition of cyclophosphamide to TPE may lead to more
prolonged remission.
TPE may be effective in the treatment of recurrent FSGS if
treatment is initiated promptly after the initiation of proteinuria.
Matalon A,Clin Nephrol 56:271-278, 2001
72. Renal Allograft Rejection
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TPE can provide a rapid decrease in anti-human
leukocyte antigen (HLA) antibodies.
However, 2 controlled trials of TPE for acute vascular
rejection did not find this treatment to be useful.
TPE together with cyclophosphamide and methylpred
has been reported to result in greater improvement in
renal function and improved graft survival.
Bonomini V,Trans Am Soc Artif Intern Organs 31:698-701, 1985
73. ABOi Renal Transplant
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TPE can be used to remove anti-A or anti-B
antibodies before transplantation.
Five-year graft survival has been as high as 78%
when kidneys from donors in blood A2 or B
subgroups are transplanted into group O recipients.
Donor-specific skin grafting can be used to predict
outcome.
Takahashi K, Am J Transplant 4:1089-1096,2004