Component Preparation and Transfusion Therapy Part 2

8/22/2019 Component Preparation and Transfusion Therapy Part 2

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COMPONENT PREPARATION & TRANSFUSION THERAPY 3/8/2013

/Maida Fatima Diaz Estira-Chan 1

PLATELET CONCENTRATESCan be produced during the routine conversion of whole blood intoconcentrated rbcs or by apheresis

essential for the formation of the primary hemostatic plug and

maintenance of normal hemostasis

FOR :

Actively bleeding patients (thrombocytopenic, less than 50 x

109/L due to decreased production or decreased function)

Cancer patients during radiation and chemotherapy because of

induced thrombocytopenia ( less than 20 x 109/L)

Thrombocytopenia preoperative patients (less than 50 x 109/L)

Not usually indicated for patients with DIC or idiopathic

thrombocytopenic purpura (ITP)

PLATELET CONCENTRATESRandom-donor platelets

Prepared from whole blood

Should contain at least 5.5 x 1010

Stored at 20 24OC with continuous agitation

Contain sufficient plasma to yield a pH of greater than or equal to 6.2

Shelf life 5 days

Single-donor platelets

prepared from apheresis

Contain at least 3.0 x 1011

Stored at 22 24OC with agitation

Contain approx. 300 ml of plasma

Shelf-life 5 days

PLATELET CONCENTRATES

Single-donor platelets

Generally indicated for patients who are unresponsive to randomplatelets due to HLA alloimmunization

To limit the platelet exposure from multiple donors

Platelet concentrate preparation

prepared within 6 hoursof collection

Centrifuge whole blood (set at 22OC) light spin 3200 rpm for 2 to 3

minutes

Platelet rich plasma is expressed into one of the satellite bags

Disconnect rbc and store it at 4OC

Recentrifuge PRP at 22OC using a heavy spin 3600 rpm for 5

minutes

Express majority of the plasma into the second satellite bag

PLATELET CONCENTRATES

Platelet concentrate preparation prepared within 6 hours

of collection

Leave approx. 50 70 ml of plasma on the platelets

To maintain a pH of 6.2 during storage

Plasma

stored as FFP, single-donor plasma frozen within 24 hours(PF24) or liquid recovered plasma

Platelet concentrate lie undisturbed for 1 to 2 hours at 20 24OC,

making sure the platelet button is covered with plasma

Shelf-life is 5 days from the date of collection

If open system, transfusion must occur within 6 hours

Label properly (volume, expiration date and time)

All units for a single dose ( 6 to 8 units) must be pooled and must be

transfused within 4 hours of pooling


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PLATELET CONCENTRATESQUALITY CONTROL PROCEDURES (monthly)

Platelet count (random-donor 5.5 x 1010 and single-donor

3.0 x 1011)

Volume must be sufficient to maintain an acceptable pH until the

end of the dating period

methods in place to limit and detect bacterial contamination in

platelet components

improved phlebotomy techniques

culture and staining methods to detect bacterial organisms

dipsticks to detect bacterial levels

a swirling technique to detect metabolic changes in platelets

Can be irradiated, leukocyte-reduced or washed

PLATELET ALIQUOTSIndicated for neonates whose counts fall below 50,000/mL and

who are experiencing bleeding

Factors that may be associated with thrombocytopenia:

1. immaturity of the coagulation system

2. platelet dysfunction

3. increased destruction of platelets

4. dilution effect secondary to massive transfusion or exchange

5. Transfusion

6. intraventricular hemorrhage

Either random or apheresed platelets may be transfused

Expiration: 4 hours

PLATELETS LEUKOREDUCEDPURPOSE OF LEUKOREDUCTION:

1. Prevention of febrile nonhemolytic reactions

2. Prevent or delay the development of HLA antibodies

3. Reduce the risk of transmission of CMV

must contain less than 8.3 x 105 leukocytes

If the platelets have been pooled, a method must be used that

results in a leukocyte count of less than 5 x106 in the final

pooled product

Single-donor or apheresis platelets that have been leukoreduced

must contain less than 5 x 106 leukocytes in at least 95% of units

tested

GRANULOCYTES PHERESISFor Patients who have received:

intensive chemotherapy for leukemia

bone marrow transplant, OR BOTH

CRITERIA:

those with fever, neutrophil counts less than 500/mL

septicemia or bacterial infection unresponsive to antibiotics

reversible bone marrow hypoplasia

a reasonable chance for survival


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GRANULOCYTES PHERESISAdults: usual dose is1 granulocyte pheresis product daily

for 4 or more days

For neonates, a portion of a granulocyte pheresis unit is

usually given once or twice

Granulocytes components should be administered as soonas possible and within 24 hours of collection

PLASMASeparated from cellular blood elements and frozen to preserve

the activity of labile coagulation factors

Plasma must be placed in the freezer within time framerequired for the anticoagulant or collection process

Stored at18OC

Cryoprecipitation is accomplished by slow thawing, at 1 to 6OC,

plasma that has been prepared for freezing within the time

frame required for the anticoagulant or collection process

Cryoprecipitate should be refrozen within 1 hour of thawing

Store at18 C or colder, preferably30 C or colder, for up to 12

months from the date of blood collection

SINGLE-DONOR PLASMA: FFPFrozen plasma from single donors may comprise FFP, PF24,

or plasma cryoprecipitate-reduced

Fresh frozen plasma (FFP)

produced from whole blood when obtained from a single,

uninterrupted nontraumatic venipuncture

plasma is frozen within 8 hours of collection (CPD, CD2D, or

CPDA-1

within 6 hours if the preservative was ACD

stored at18OC for 1 year or65OC for 7 years

contains maximum levels of labile and nonlabile clotting factors

about 1 IU per ml

SINGLE-DONOR PLASMAPlasma frozen within 24 hours after phlebotomy

(PF24/FP24)

frozen within 8 to 24 hours of collection

Stored at18OC

contains all stable proteins found in FFP

Both PF24 and FFP are thawed at temperatures between 30

and 37OC or in an FDA-approved microwave device

Product should be stored within 1 to 6OC for no more than 24 hours

(after thawing)

Indicated in patients who are actively bleeding and have multiple

clotting factor deficiencies


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SINGLE-DONOR PLASMAA single unit of FFP or PF24:

should contain 150 to 250 mL of plasma

approximately 400 mg of fibrinogen

1 unit of activity per mL of each of the stable clotting factors

FFP also contains the same level (1 unit/mL) of factors V and

VIII

Plasma cryoprecipitate reduced (cryopoor plasma)

Supernatant remaining from the production of cryoprecipitate

used exclusively in the treatment of thrombotic

thrombocytopenic purpura.

Cryoprecipitate has been removed from the plasma product and stored

at 18OC or colder, expiration is 1 year from date of collection

PLASMA AND LIQUID PLASMACan be prepared directly from whole blood or as a by-product of

platelet concentrate or cryoprecipitate production

Can be used as volume expanders or for the manufacturing of

plasma fractionation products such as:

plasma protein fraction (PPF)

normal serum albumin (NSA)

immune serum globulin (ISG)

Plasma in a unit of whole blood can be separated during storage and up

to 5 days after the expiration date

Stored at18OC or colder and labeled as plasma with a shelf-life of 5

years

can be transfused up to 5 days after the expiration date of the whole

blood

S/D POOLED PLASMAConsists of pools of no more than 2500 units of ABO type-

specific plasma

treated with solvent/detergent in the thawing process

to inactivate lipid-enveloped viruses such HIV and hepatitis B

Solvent tri-n-butyl phosphateDetergent triton X-100

Product volume is approximately 200 mL

Contains stable and labile clotting factors but lacks von Willebrands

factor multimers

Does not protect against the nonlipid enveloped viruses such as

hepatitis A and B19 parvovirus

CRYOPRECIPITATED ANTIHEMOPHILIC FACTORCold-precipitated concentration of factor VIII, the antihemophilic

factor (AHF)

Prepared from FFP thawed slowly (14 16 h)between 1 and 6OC

Suspended in less than 15 mL of plasma

Contains:

most of the factor VIII and part of the fibrinogen from the original

plasma

at least 80 units of AHF activity and at least 150 mg of fibrinogen

Others: factor XIII and von Willebrands factor

has a shelf-life of 12 months in the frozen state and must be

transfused within 6 hours of thawing or within 4 hours of pooling


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CRYOPRECIPITATED ANTIHEMOPHILIC FACTORLike FFP and PF24, cryoprecipitate should be thawed quickly at

37OC

Once thawed, store at room temperature (22 to 24O

C untiltransfused

Indicated in the treatment of:

1. Classic hemophilia (hemophilia A)

2. von Willebrands disease

3. Factor XIII deficiency and as a

4. source of fibrinogen for hypofibrinogenemia

Store at18C or colder up to 12 months from the date of whole

blood collection

CRYOPRECIPITATE

Constituents Amount

Factor VIII 80 120 U/concentrate

Fibrinogen 150 250 mg/concentrate

vWF 40 70% of original FFP

Factor XIII 20 30% of original FFP

Cold insoluble portion of plasma remaining after FFP has

been thawed at refrigerator temperatures

NOVOSEVEN Recombinant activated factor VII (NovoSeven, Denmark)

Induces hemostasis in life- and limb-threatening bleeds and in

major surgery of hemophilia A and B patients in the presence of

inhibitors

Factor VIIa binds to activated platelets and activates small

amounts of FX independent of tissue factor and that the platelet

surface FXa can restore platelet surface thrombin generation in

hemophilia

useful in hemophilia patients who have developed inhibitors to

factor VIII

FACTOR VIII CONCENTRATESUsed in the treatment of classic hemophilia and hemophilia

A and in persons deficient in factor VIII

Prepared from large volumes of pooled plasma or in the form

of recombinant FVIII using DNA technology

Techniques used to inactivate or eliminate viralcontamination:

1. Pasteurization

2. Solvent/detergent treatment

3. Monoclonal purification


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FACTOR VIII CONCENTRATES1. Pasteurization

Stabilizers such as albumin, sucrose, or glycine are added to the factorVIII concentrate to prevent denaturation of the product

Heated to 60OC for 10 hours

Stabilizers are removed, and the product is lyophilized

2. Solvent/detergent treatment

Use of ethyl ether and tri(n-butyl) phosphate and the detergent sodium

cholate and Tween 80

Removed then lyophilized

3. Monoclonal purification

Immunoaffinity chromatography

used to positively select out of pooled plasma the vWF:FVIII complex

PORCINE FACTOR VIII

Xenographic form of factor VIII

Made from porcine plasma

Beneficial for patients with hemophilia A who havedeveloped inhibitors or antibodies to human factor VIII

Shown to provide effective hemostatic control for patients

with intermediate FVIII inhibitor levels

Residual porcine vWF in the preparation of the product

induces platelet activation

Enhancing hemostasis apart from the action of circulating

FVIII

RECOMBINANT FACTOR VIIIProduction of recombinant human FVIII (rFVIII)

Synthesized by introducing human FVIII gene into BHK

(baby hamster kidney cells)

rFVIIIreleased into culture medium and harvested,

isolated, and purified using a combination of ion exchange

chromatography, gel filtration, and immunoaffinity

chromatography

Purification and final formulation Human albumin as a

stabilizer

Next generation : rFVIII:FS uses sucrose as final

stabilizer

FACTOR IX CONCENTRATESThree forms:

1. Prothrombin complex concentrates

contains significant levels of vitamin Kdependent factors: II, VII,

IX, and X

prepared from large volumes of pooled plasma by absorbing the

factors out using barium sulfate or aluminum hydroxide

lyophilized and virally inactivated

may contain activated vitamin Kdependent factors

2. Factor IX concentrates

developed by monoclonal antibody purification

less thrombogenic than prothrombin complex concentrates


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FACTOR IX CONCENTRATES2. Factor IX concentrates

contains approximately 20 to 30% of FIX

stored in the refrigerator in lyophilized form3. Recombinant factor IX (rFIX)

produced in a Chinese hamster ovary cell line and not thought to

transmit human infectious disease

treatment of patients with hemophilia B

FACTOR XIII CONCENTRATESFactor XIII deficiency a severe autosomal-recessive

bleeding disorder associated with a characteristic pattern of

neonatal hemorrhage and a lifelong bleeding diathesisThere are currently two plasma-derived virus inactivated

factor XIII concentrates:

1. Fibrogammin P

available in Europe, South America, South Africa, and Japan

2. Factor XIII concentrate (Bio Products Laboratory, Elstree,

UK)

UK

IMMUNE SERUM GLOBULINImmune globulin is indicated for:

1. Patients with immunodeficiency diseases (i.e. severe combined

immunodeficiency and Wiskott-Aldrich syndrome)

2. Providing passive antibody prophylaxis against hepatitis and

herpes

Concentrate of plasma gamma globulins in an aqueous

solution

Prepared from pooled plasma by cold ethanol fractionation

Administered IV or IM

Half-life of 18 to 32 days

IMMUNE SERUM GLOBULINIVIg is also used in patients with:

Idiopathic thrombocytopenic purpura

Post-transfusion purpura

HIV-related thrombocytopenia

Neonatal alloimmune thrombocytopenia (NAIT)

Contraindications:

Individuals with a history of IgA deficiency or anaphylactic

reactions should not receive immune globulin

because of the presence of trace amounts of IgA


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NORMAL SERUM ALBUMIN (NSA)Prepared from salvaged plasma

Pooled and fractionated by a cold alcohol process

Treated with heat inactivation (60O

C for 10 hours), whichremoves the risk of hepatitis or HIV infection

Composed of: 96% albumin and 4%globulin

Albumin used routinely as the replacement fluid in many

plasmapheresisprocedures

replacing the colloid that is removed during the procedures

Can be used with diuretics to induce diuresis in patients with low

total protein because of severe liver or protein-losing disease

NSAAvailable in 25% or 5% solutions

Intended for:

patients who are hypovolemic hypoproteinemic

In clinical settings of shock

burn patients

25%preparation is contraindicated in patients who are

dehydrated

unless it is followed with crystalloid infusions (e.g., normal saline)

for volume expansion

PLASMA PROTEIN FRACTION (PPF)Contains 83% albumin and 17% globulins

Similar in preparation with NSA with lesser purification steps

available in a 5% preparation

Similar use to that of NSA

contraindicated for infusion during cardiopulmonary bypass

procedures

PPF and NSA can be stored for 5 years at 2 to 10OC and

have not been reported to transmit HIV or hepatitis

RhO (D) IMMUNOGLOBULINRh immunoglobulin (RhIg) is a solution of concentrated anti-Rho(D)

prepared from pooled human plasma of patients who have

been hyperimmunized and contains predominantly IgG anti-D

Has 2 primary uses: (1) treatment of ITP and (2) prevention

of Rh HDN

During the first 12 weeks of pregnancy, a 50-mg dose of RhIg

is indicated for D-negative females for abortion or

miscarriage


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RhO (D) IMMUNOGLOBULINAfter 12 weeks gestation, a full dose (300 mg) is indicated

for abortion or miscarriage in D negative women

120-mg dose is advised after 34 weeks gestation: When amniocentesis is performed

In the event of obstetric complication or following termination of

pregnancy

RhIg is also used in the event Rh-positive components are

transfused to Rh-negative patients

A 300-g dose IM (120-mg dose IV) is sufficient to protect against D-

positive RBCs contained in 10 units of random platelets

SYNTHETIC VOLUME EXPANDERSTWO CATEGORIES:

1. Crystalloids

Ringers lactate consists of Na, Cl, K, Ca, and lactate ions

normal isotonic saline Na and Cl ions

2. Colloids

Dextran prepared in a 6 and 10% solution with a half-life of 6

hours

HES available in a 6% solution with an IV half-life of more than

24 hours

used as volume expanders in hemorrhagic shock and burn

patients

SYNTHETIC VOLUME EXPANDERSCHARACTERISTIC COLLOID CRYSTALLOID

Intravascular Retention Good Poor

Peripheral edema Possible Common

Pulmonary edema Possible PossibleEasily excreted No Yes

Allergic reactions Rare Absent

Cost Expensive Inexpensive

Examples Albumin

Dextran

Ringers lactate

solution

Hydroxyethyl starch 7.5% Normal saline

ANTITHROMBIN III CONCENTRATESAntithrombin-III concentrates (AT-III) or antithrombin (AT)

an inhibitor of clotting factors IX, X, XI, XII, and thrombin

prepared from pooled human plasma and heat-treated to

prevent viral transmissionfor treatment of patients with hereditary AT deficiency in

connection with surgical or obstetrical procedures

Or when they suffer from thromboembolism

rhAT is produced by transgenic goats expressing

recombinant human AT in their milk

Component Preparation and Transfusion Therapy Part 2

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