- Red Blood Cells, Packed Red Cells, RBC's
- Plasma & Cryopreciptate
- Recombinant Factor VIIa
Description: Red Blood Cells
A unit of RBC is prepared from a whole blood collection using a closed sterile system. Blood is drawn into a bag containing the anticoagulant CPD. Most of the platelet rich plasma is separated with a centrifuge and separated into an attached container. 100 ml of an additive nutritive solution is added to RBC. The additive solution supports red cell survival and extends the shelf life of the unit to 42 days. The added fluid volume also reduces the unit's hematocrit to ~57% (range 50 to 65%), thereby improving the flow characteristics of the component.
To lessen the risks of exposure to donor leukocytes, all MMC RBC units, with the exception of autologous donations, are passed through a leukoreduction filter by the supplier. Leukocytes in the transfused unit can be further reduced by washing or exposure to gamma radiation.
For patient populations where prevention of transfusion-transmitted cytomegolovirus infection is important, RBC units from donors who have been screened for CMV antibodies are available.
Types & Terms; Red Blood Cells
- Leuko-Reduced RBCs: All pRBCs at MMC are passed through a leukoreduction filter by the supplier, to diminish the frequency of febrile non-hemolytic transfusion reaction.
- Irradiated RBCs: In immunocompromised patients and where there a partial HLA match between recipient and donor blood, RBCs are gamma-irradiated to prevent Transfusion-Associated Graft vs. Host Disease
- Washed RBCs: In order to prevent or eliminate complications associated with infusion of proteins present in the small amount of residual plasma in red cell concentrates, a unit of blood can be washed immediately before infusion. This is indicated for the following conditions:
- Patients with severe or recurrent allergic reactions (eg, hives) associated with red cell transfusion.
- Certain patients with IgA deficiency, when IgA deficient donors are not available (although frozen deglycerolized red cells may be the component of choice); patients with IgA deficiency may have circulating anti-IgA antibodies that react with IgA in the donor plasma.
- In the rare patient with a complement-dependent autoimmune hemolytic anemia to prevent complement infusion.
- Volume-Reduced RBCs: pRBCs where added solution is removed prior to transfusion to reduce TACO (Transfusion-Associated Circulatory Overload)
- Frozen RBCs: RBC units can be frozen when buffered with glycerol, but this is an expensive and time consuming process, and is rarely done. Frozen red cells are given an expiration date of up to ten years and are stored at −65 °C.
- Whole blood should be considered only when treating an adult who has bled acutely and massively.
Indications for transfusing Red Blood Cells:
- Blood loss anemia (acute or chronic)
- Symptomatic anemia with normovolemia
- Estimated acute blood loss of >15% of total blood volume
- Hemoglobin <8 or Hematocrit <24%
- Hemoglobin <9 or Hematocrit <27% on chronic transfusion therapy
- Acute blood loss with inadequate oxygen delivery
- Acute blood loss, patient >4 months old and >15% EBV
- Acute blood loss, patient <4 months old and >10% EBV in <1 week
- Chronic transfusion regimen for thalassemia or other RBC-dependent disorder
- Complication of sickle cell disease
- Hemoglobin <10 with impending surgery and <4 months old
- Hemoglobin <13 with severe cardiopulmonary disease in a pedi/neonatal pt
- Hemoglobin <8 or Hematocrit <24%
- Hemoglobin <9 with chronic transfusion therapy (chemo, radiation)
Description: Fresh frozen plasma (FFP)
Fresh frozen plasma (FFP) is the plasma removed from a single unit of whole blood and frozen at or below -18° Centigrade within eight hours of collection; shelf life is one year from date of collection.
FFP contains all coagulation factors in normal amounts and is free of red cells, leukocytes and platelets, slightly diluted by the citrate-anticoagluant. It is not a concentrate of clotting factors (see Cryoprecipitate)
One unit of FFP is approximately 225 ml and must be ABO compatible with the recipient’s red cells, Rh need not be considered.
Indications for transfusing FFP:
- PT >16 seconds and/or PTT >45 seconds and
- invasive procedure or clinically significant bleeding
- Anticoagulant deficiencies (proteins C or S, antithrombin) when specific treatment is unavailable
- Thrombotic thrombocytopenia purpura or
- Hemolytic-uremic syndrome
Plasma Cryoprecipitate Reduced is plasma from which Cryoprecipitate has been removed. This product is also referred to as Cryo-Poor Plasma.
It has been employed as plasma replacement in some patients with thrombotic thrombocytopenic purpura.
Cryo-Poor Plasma is suitable for use in patients with vitamin K deficiency or correction of bleeding in the setting of warfarinanticoagulation because the removal of Cryoprecipitate from plasma does not deplete the vitamin K-dependent clotting factors (table 1).
Cryoprecipitate is the precipitate that forms when FFP is thawed at 4°C. This precipitate is separated from the plasma by centrifugation. This product is also referred to as "cryo".
Cryo is a concentrated preparation that contains virtually all of the
- factor VIII,
- factor XIII, and
- von Willebrand factor (VWF)
from the FFP, reduced from an initial volume of 250 mL to a final volume of 10 to 20 mL.
The remaining material can be refrozen and used as Plasma Cryoprecipitate Reduced (or Cryo-Poor Plasma). (See 'Plasma Cryoprecipitate Reduced' above.)
Cryoprecipitate contains approximately 200 mg of fibrinogen and 100 units of factor VIII (80 to 110 international units) per unit and carries an approximately equivalent infectious risk as a unit of plasma.
Some blood suppliers now provide pre-pooled Cryoprecipitate (one "bag") containing theCryoprecipitate obtained from five (or more) units of plasma. The clinician should check with the local hospital transfusion service or blood supplier to determine the exact composition of one "bag" of Cryoprecipitate in order to determine the correct dosage for a patient.
Indications for transfusing Cryoprecipitate:
- Congenital and acquired deficiencies of fibrinogen and factor XIII
- Ten units of Cryoprecipitate (obtained from 10 units of plasma) contain approximately 2 g of fibrinogen and will raise the fibrinogen level approximately 70 mg/dL in a 70 kg recipient
- Obsolete Indications for Cryo:
- Cryoprecipitate for the treatment of hemophilia has become obsolete due to the availability of factor concentrates and recombinant factor products. Cryoprecipitate should not be used for the treatment of hemophilia unless none of these products are available, due to risks of viral transmission.
- Cryoprecipitate contains large multimers of VWF and factor VIII, and was used previously for managing von Willebrand disease (VWD), hemophilia A, and factor XIII deficiency. However, the availability of other therapies with less risk of complications (eg, factor concentrates, including a factor XIII concentrate licensed in 2013, desmopressin [DDAVP], recombinant products) have made the use of Cryoprecipitate obsolete in these conditions, unless these more specific therapies are unavailable.
A platelet transfusion may be prepared by pooling platelet components separated from multiple units of whole blood ("Platelets" or "platelet concentrates"), or by a single donor pheresis procedure ("Platelets, Pheresis" or "single donor platelets").
A unit of single donor platelets usually contains the equivalent of six or more platelet concentrates, the dose commonly administered for a single platelet transfusion in an adult.
Platelets are stored at room temperature and may be kept for a maximum of five days.
Whenever possible the plasma of a platelet component should be ABO compatible with the recipient's red cells, particularly if the recipient is a child.
Indications for transfusing platelets:
- Platelets <20,000
- Platelets <50,000 and stable premature infant (<37 weeks)
- Platelets <50,000 and bleeding or impending invasive procedure or perioperative
- Platelets <100,000 and sick premature infant (<37 weeks)
- Platelets <100,000 and post CPB or IABP with diffuse bleeding
- Platelets <100,000 and trauma or invasive procedure to CNS or eye
- Bleeding and a qualitative platelet defect
BUMINATE 5% Albumin (Human), USP, 5% Solution
Bottle contains 12.5 g albumin from venous plasma in saline and is osmotically equivalent to an equal volume of normal human plasma. It has been stabilized with sodium caprylate and sodium acetyltryptophanate and heated for 10 hours at 60°C. The sodium content is 145 ±15 mEq/L. Contains no preservative. Store at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the bottle. See attached directions for use. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Single dose container. Discard partially used bottle.
BUMINATE 5%, Albumin (Human), 5% Solution is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 5 g of albumin and is prepared from human venous plasma using the Cohn cold ethanol fractionation process. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and has been stabilized with sodium acetyltryptophanate and sodium caprylate. The sodium content is 145 ±15 mEq/L. The solution contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. BUMINATE 5%, Albumin (Human), 5% Solution is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color.
The likelihood of the presence of viable hepatitis viruses has been reduced by heating the product for 10 hours at 60°C. This procedure has been shown to be an effective method of inactivating hepatitis virus in albumin solutions even when those solutions were prepared from plasma known to be infective.
BUMINATE 5%, Albumin (Human), 5% Solution contains no blood group isoagglutinins thereby permitting its administration without regard to the recipient's blood group.
Hypovolemia is a possible indication for use of BUMINATE 5%, Albumin (Human), 5% Solution. Its effectiveness in reversing hypovolemia depends largely upon its colloid osmotic pressure. Although crystalloid solutions and colloid-containing plasma substitutes can be used in emergency treatment of shock, Albumin (Human) has a longer intravascular half-life than crystalloid solutions.9
When the hypovolemia is long-standing and hypoalbuminemia exists accompanied by adequate hydration or edema, treatment with BUMINATE 25%, Albumin (Human), 25% Solution is preferable.4,6
When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible.
General Hypoalbuminemia is another possible indication for use of BUMINATE 5%, Albumin (Human), 5% Solution. Hypoalbuminemia can result from one or more of the following:5
- Inadequate production (malnutrition, burns, major injury infections, etc.)
- Excessive catabolism (burns, major injury, pancreatitis, etc.)
- Loss from the body (hemorrhage, excessive renal excretion, burn exudates, etc.)
- Redistribution within the body (major surgery, various inflammatory conditions, etc.)
When albumin deficit is the result of excessive protein loss, the effect of administration of albumin will be temporary unless the underlying disorder is reversed. In most cases, increased nutritional replacement of amino acids and/or protein with concurrent treatment of the underlying disorder will restore normal plasma albumin levels more effectively than administration of albumin solutions. Occasionally hypoalbuminemia accompanying severe injuries, infections or severe pancreatitis cannot be quickly reversed and nutritional supplements may fail to restore adequate plasma albumin levels. In these cases, BUMINATE 5%, Albumin (Human), 5% Solution may be useful.
In conjunction with appropriate crystalloid therapy, BUMINATE 5%, Albumin (Human), 5% Solution may be useful for treatment of protein deficits after the initial 24-hour period following extensive burns.4
BUMINATE 5%, Albumin (Human), 5% Solution may be indicated prior to or during cardiopulmonary bypass surgery, though the data do not indicate a clear-cut advantage over crystalloid solutions.4,6,10
There is no valid reason for use of albumin as an intravenous nutrient.
DOSAGE AND ADMINISTRATION
BUMINATE 5%, Albumin (Human), 5% Solution must be administered intravenously. It may be administered either in conjunction with or combined with other parenterals such as whole blood, plasma,saline, glucose or sodium lactate. The volume of the total dose and the rate of infusion depends on the patient's condition and response.
Hypovolemia Although the volume of BUMINATE 5%, Albumin (Human), 5% Solution administered must be individualized, the initial dose should be 250 to 500 mL for older children and adults and 12 to 20 mL per kilogram of body weight for infants and young children. It may be repeated after 30 minute intervals if the response is not adequate.
Hypoalbuminemia Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia. When using the patient's serum albumin concentration to estimate the deficit, the body albumin compartment should be calculated to be 80 to 100 mL per kilogram of body weight.5,6 Daily dose should not exceed 2 g of albumin per kilogram of body weight.
Burns When BUMINATE 5%, Albumin (Human), 5% Solution is administered after the first 24 hours following burns, an initial dose of 500 mL is recommended.
BUMINATE 5%, Albumin (Human), 5% Solution is supplied in 250 mL and 500 mL bottles.
Storage Store BUMINATE 5%, Albumin (Human), 5% Solution at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the bottle.
A history of allergic reactions to albumin is a specific contraindication to the use of this product.
BUMINATE 5%, Albumin (Human), 5% Solution is also contraindicated in severely anemic patients and in patients with cardiac failure.
CLINICAL PHARMACOLOGY Albumin is responsible for 70-80% of the colloid osmotic pressure of normal plasma, thus making it useful in regulating and increasing blood volume.4,5,6 It is also a transport protein and binds naturally occurring, therapeutic and toxic materials in the circulation.5,6 BUMINATE 5%, Albumin (Human), 5% Solution is osmotically equivalent to an equal volume of normal human plasma and will increase circulating plasma volume by an amount approximately equal to the volume infused. The degree and duration of volume expansion depends upon the initial blood volume. With patients treated for diminished blood volume, the effect of infused albumin may last for many hours. In patients with normal blood volumes, the hemodilution lasts for a shorter period.7,8
Total body albumin is estimated to be 350 g for a 70 kg man and is distributed throughout the extracellular compartments. The half-life of albumin is 15 to 20 days with a turnover of approximately 15 g per day.5
The minimum plasma albumin level necessary to prevent or reverse peripheral edema is unknown. Some investigators recommend that plasma albumin levels be maintained at approximately 2.5 g/dL. This concentration provides a plasma oncotic pressure value of 20 mm Hg.
BUMINATE 5%, Albumin (Human), 5% Solution is manufactured by the modified Cohn-Oncley cold ethanol fractionation process which includes a series of cold-ethanol precipitation, centrifugation and/or filtration of human plasma followed by pasteurization of the final product at 60 ± 0.5°C for 10 - 11 hours. This process accomplishes both purification of albumin and the reduction of viruses.
4. Tullis JL: Albumin, 1. Background and use, and 2. Guidelines for clinical use. JAMA 237:355-360,460-463, 1977
5. Peters T Jr: Serum albumin, in The Plasma Proteins, 2nd ed, Vol 1. Putnam FW (ed). New York, Academic Press, 1975, pp 133-181
6. Finlayson JS: Albumin products. Sem Thromb Hemostas 6:85-120, 1980
9. Shoemaker WC, Schluchter M, Hopkins JA, et al: Comparison of the relative effectiveness of colloids and crystalloids in emergency resuscitation. Am J Surg 142:73-83, 1981
10. Lowenstein E, Hallowell P, Bland JHL: Use of colloid and crystalloid solutions in open heart surgery: Physiological basis and clinical results, in Proceedings of the Workshop on Albumin. Sgouris JT, Rene A (eds.) DHEW Publication No. (NIH) 76-925, Washington DC, U.S. Government Printing Office, 1976, pp 195-210