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fresh frozen plasma (Blood Component)Brand and Other Names:FFP, Octaplas

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

pooled human plasma solution (Octaplas)

  • 45-70mg/mL (as human plasma protein)
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Management/Prevention of Bleeding

FFP: 10-20 mL/kg of body weight will increase factor levels by 20-30%

Frequency of transfusion depends on the half-life of the deficient factor(s)

In adults and large children, dosing is rounded to the nearest number of units

Number of units = Desired dose (mL) / 200 mL/unit

Coagulation Factors Replacement

Indicated for replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or those undergoing cardiac surgery or liver transplantation

Octaplas: 10-15 mL/kg IV initially; this should increase plasma coagulation factors by ~15-25%

If hemostasis not achieved, use higher doses and adjust dose based on desired clinical response

Monitor response, including measurement of aPTT, PT, and/or specific coagulation factors

Thrombotic Thrombocytopenic Purpura (TTP)

Indicated for plasma exchange in patients with TTP

Octaplas: Completely replace plasma volume removed during plasmapheresis with Octaplas; generally, 1-1.5 plasma volumes corresponds to 40-60 mL/kg IV

Administration (Octaplas)

Administer via infusion set with filter

Inspect visually for particulates and discoloration; do not use if turbid

Avoid shaking

Not to exceed IV infusion rate of 1 mL/kg/min

Dosing Considerations

Administer based on ABO-blood group compatibility

Other Indications & Uses

Fresh Frozen Plasma, Plasma Frozen within 24 hours, Thawed Plasma, Liquid Plasma (FFP, P24, TP, LP) may be used to treat bleeding due to acquired multiple factor deficiencies such as seen due to large volume bleeding or DIC.

Plasma transfusion is indicated for

  • Management of bleeding or to prevent bleeding prior to an urgent invasive procedure in patients requiring replacement of multiple coagulation factors
  • Massively transfused patients who have clinically significant coagulation deficiencies and hypovolemia
  • Patients on warfarin therapy with bleeding or that need to undergo an invasive procedure before vitamin K could reverse the effects of warfarin or who need only transient reversal of warfarin effects
  • For transfusion or plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP) and some cases of hemolytic uremic syndrome (HUS)
  • Management of patients with selected coagulation factor deficiencies, congenital or acquired, for which no specific coagulation concentrates are available (i.e., factors II (2), V (5), VII (7), X (10), XI (11), Proteins C or S*
  • Management of patients with rare specific plasma protein deficiencies, such as C1 inhibitor, when recombinant products are unavailable*
  • FFP is the product of choice for patients specifically requiring replacement of the labile clotting factors or other proteins with poor storage stability because the other plasma products may be deficient in these factors during liquid storage; deficiencies due to consumption/hemodilution rarely fall to levels that are inadequately treated with non-FFP plasma components; consultation with a hematologist or transfusion medicine physician is recommended for assistance with indications 3-6

Management/Prevention of Bleeding

Octaplas: Safety and efficacy in children not established

Neonates and small children

  • FFP: 10-15 mL/kg of body weight will increase factor levels by 15-25%
  • Transfusion frequency depends on the half-life of the deficient factor(s)
  • Depending on the dose requested, an aliquot of 1 unit, a whole unit or more than 1 unit of plasma may be issued
  • Specific volume to be transfused should be specified to the transfusionist to prevent volume overload in neonates and small children or those at increased risk of volume overload

Large children

  • Please see adult dosing
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Adverse Effects

≥1% (Octaplas)

Nervous system: Headache, paresthesia

Gastrointestinal: Nausea

Skin and subcutaneous tissue disorders: Pruritus, urticaria

Frequency Not Defined (FFP)

Hemolytic Transfusion Reactions

Febrile Non-Hemolytic Reactions

Allergic Reactions ranging from urticaria to anaphylaxis

Septic Reactions

Transfusion Related Acute Lung Injury (TRALI)

Circulatory Overload

Transfusion Associated Graft Versus Host Disease

Post-transfusion Purpura

Postmarketing Reports (Octaplas)

Blood system disorders: Hyperfibrinolysis

Immune system disorders: Hypersensitivity reactions including anaphylactoid and allergic type of reactions

Metabolic and nutritional disorders: Alkalosis

Cardiovascular disorders: Cardiac arrest, circulatory overload, thromboembolism, tachycardia

Respiratory, thoracic and mediastinal disorders: Respiratory arrest or failure, bronchospasm, pulmonary edema, dyspnea, tachypnea

Gastrointestinal disorders: Abdominal pain, vomiting

Skin and subcutaneous tissue disorders: Rash, erythema

General disorders and administration site conditions: Fever and/or chills, chest discomfort or pain

Investigations: Seroconversions (passive transfer of antibodies)

Injury, poisoning and procedural complications: Citrate toxicity

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Warnings

Contraindications

FFP should not be used solely for volume expansion, or to "correct" a mildly prolonged PT or PTT without active bleeding; patients may have a mildly prolonged PT or PTT and yet have hemostatically stable levels of coagulation factors

Plasma should not be given for replacement of isolated factor or specific protein deficiencies if the appropriate factor concentrates are available

Plasma should not be given for vitamin K deficiency or warfarin reversal if correction can safely be achieved using vitamin K supplementation

Octaplas

  • IgA deficiency
  • Severe protein S deficiency
  • History of hypersensitivity to fresh frozen plasma (FFP) or to plasma-derived products including any plasma protein
  • History of hypersensitivity reaction to Octaplas

Cautions (FFP)

If a transfusion reaction is suspected, the transfusion should be stopped, the patient assessed and stabilized, the blood bank notified, and a transfusion reaction investigation initiated

Massive or rapid transfusion may lead to arrhythmias, hypothermia, hyperkalemia, hypocalcemia, dyspnea, and/or heart failure

Many blood banks utilize P24 and/or thawed plasma interchangeably with FFP; if FFP is specifically needed, it is advisable to inform your institution’s blood bank at the time of request to ensure appropriate product transfusion

Plasma components contain a significant amount of antibodies against the ABO blood group antigens and ABO compatible plasma must be used

Liquid plasma (please see pharmacology for description) may have a significant amount of viable lymphocytes and should be irradiated if the patient is at increased risk of TA-GVHD (see the irradiated blood product monograph)

All transfusions must be given via blood administration sets containing 170- to 260-micron filters or 20- to 40-micron microaggregate filters unless transfusion is given via a bedside leukocyte reduction filter; no other medications or fluids other than normal saline should be simultaneously given through the same line without prior consultation with the medical director of the blood bank

Patient’s should be monitored for signs of a transfusion reaction including vitals pre, during, and post transfusion.

Non-septic infectious risks include transmission of HIV (~1:2 mill), HCV (~1:1.5 mill), HBV (1:300k), HTLV, WNV, CMV, parvovirus B19, Lyme disease, babesiosis, malaria, Chaga’s disease, vCJD

Consult with blood bank medical director or hematologist if you have questions regarding special transfusion requirements

Cautions (Octaplas)

Transfusion reaction may occur with ABO mismatch

High infusion rates can induce hypervolemia with consequent pulmonary edema or cardiac failure

Excessive bleeding due to hyperfibrinolysis can occur due to low levels of alpha2-antiplasmin (ie, plasmin inhibitor); monitor for signs of excessive bleeding in patients undergoing liver transplantation

Thrombosis can occur due to low levels of Protein S

Octaplas is made from human plasma, it may carry a risk of transmitting infectious agents (eg, viruses, vCJD agent); undergoes solvent-detergent purification

Do not inject drugs containing calcium in the same IV line (precipitant may occur)

Citrate toxicity

  • Citrate toxicity can occur with volumes exceeding 1 mL/kg/min of Octaplas
  • Do not exceed infusion rate of 0.02-0.025 mmol/kg/min of citrate (ie, <1 mL/kg/min Octaplas)
  • Symptoms attributable to citrate toxicity (hypocalcaemia) include fatigue, paresthesia, and muscle spasms, especially in patients with liver function disorders
  • Administer calcium gluconate IV into another vein in order to minimize citrate toxicity
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Pharmacology

Mechanism of Action

Each unit provides all plasma proteins and clotting factors to support adequate hemostasis to treat or prevent bleeding or to treat other protein deficiencies that cannot be replaced with protein specific concentrates

Description

Fresh frozen plasma (FFP): Plasma from a unit of whole blood separated by centrifugation and frozen within 8 hours of collection

P24 plasma: Essentially the same as FFP except that the separation and centrifugation occurred between 8 and 24 hours of collection

Thawed plasma: Either FFP or P24 plasma that has been relabeled after being stored thawed for 24 hr

Liquid plasma: Plasma that has been separated from whole blood and never frozen

Pooled plasma and solvent-detergent treated pooled plasma are now available in the United States (Octaplas)

Storage

FFP

  • Stored at -18º C (negative 18º C) or colder for up to 12 months
  • Thaw at 30-37ºC and kept at 1-6º C for no longer than 24 hours after thawing
  • FFP contains an average of 1 IU/mL of each coagulation factor, including the labile factors V and VIII  

P24 plasma

  • May have decreased amounts of labile proteins such as factors VIII (8) and V (5)

Thawed plasma

  • Thawed plasma may be stored for an additional 4 days reducing the wastage of untransfused FFP or P24; it contains sufficient amounts of stabile proteins and clotting factors for most indications of plasma transfusion
  • By day 5 of storage the amount of factor VIII (8) is reduced by up to 40% and factors V (5) and VII (7) may be reduced by up to 20% 

Liquid plasma

  • Maximum storage of 5 days longer than the unit of whole blood it was collected from
  • Like thawed plasma the amount of labile clotting factors are reduced with extended storage but contains sufficient amounts of stabile clotting factors
  • This product is almost solely used in for emergency transfusions, such as in trauma cases, when plasma is needed more rapidly than frozen plasma products can be thawed and prepared for issue
  • Not all institutions keep liquid plasma on stock

Octaplas

  • Store at ≤-18°C (-0.4°F) protected from light
  • Use thawed product with 12 hr if stored at 2 -4°C (35.6-39.2°F) or within 3 hr if stored at 20 - 25°C (68-77°F)
  • Do not refreeze thawed product
  • Discard unused product
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