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RED CELL CONCENTRATE

Red Blood Cells; Concentrated Red Blood Cells; Packed Red Cells (PRC).

      Caution Red Cell Concentrate shall be administered only through a 170 to 200 μm filter as transfusion equipment for medical use.

 

Category Human blood and blood products.

         Red Cell Concentrate is the portion of blood that contains hemoglobin and is derived from human whole blood, from which plasma and platelets are removed by centrifugation, sedimentation, or by apheresis. In the case of apheresis, the plasma is automatically removed and returned directly to the donor.

         Red Cell Concentrate derived from whole blood may be prepared at any time during the dating period of the whole blood from which it is derived. Red Cell Concentrate may be further processed by addition of red cell preservatives, irradiation to inactivate lymphocytes, filtration for removal of leukocytes, washing to remove proteins, freezing and thawing, or rejuvenation using validated and approved procedures. The source blood for Red Cell Concentrate must comply with the requirements as described under Blood, Whole, p. 188. A unit (dose) of Red Cell Concentrate contains a minimum of 50 g of hemoglobin in a total volume of approximately 180 to 325 ml. A unit (dose) of Red Cell Concentrate, Leukocytes Reduced contains a minimum of 42.5 g of hemoglobin in a total volume of approximately 150 to 275 ml, and has a residual leukocyte count of less than 5 × 106 . A unit (dose) of Red Cell Concentrate, Deglycerolized contains a minimum of 40 g of hemoglobin in a total volume of approximately 180 to 325 ml. A unit (dose) of Red Cell Concentrate, Leukocytes Reduced and Deglycerolized contains a minimum of 34 g of hemoglobin in a total volume of approximately 180 to 325 ml and has a residual leukocyte count of less than 5 × 106 . A unit (dose) of Red Cell Concentrate, Pheresis contains a mean hemoglobin content of 60 g of hemoglobin. A unit (dose) of Red Cell Concentrate, Pheresis, Leucocytes Reduced contains a mean hemoglobin content of 51 g (or 153-ml packed red cell volume, and has a residual leukocyte count of less than 5 × 106 .

Description Dark red fluid. After standing the red cells may sediment leaving a supernatant layer of yellow plasma.

Strength available The red cell equivalent of 1 Unit (450±45 ml) of human whole blood.

Dose Intravenous infusion, as needed to replenish red cells, prime extracorporeal circuits, etc, the equivalent of 1 Unit of Whole Blood, repeated as necessary.

Warning The high rate of alloimmunization among patients with sickle-cell anemia could be due to racial differences between donors and recipients.

See also under Blood, Whole, p. 188.

Additional information

         1. Before transfusion of Red Cell Concentrate compatibility tests shall be carried out with the blood of the intended recipient and the identity of that recipient shall be indicated on the container.

         2. One unit in a 70-kg recipient increases the hematocrit about 3 per cent.

Expiration date Red Cell Concentrate in ACD and CPD may be stored for up to 21 days at 2º to 6º after the blood has been drawn. Red Cell Concentrate in CPDA-1 may be stored for up to 35 days at 2º to 6º. Red Cell Concentrate may be stored in an approved additive solution (AS), for up to 42 days at 2º to 6º. If the hermetic seal of the container is broken during collection, preparation, or further processing, the expiration date is not later than 24 hours after the seal is broken (when blood is stored at 2º to 6º). The expiration date for frozen Red Cell Concentrate prepared with low glycerol content (20 per cent glycerol) is not later than 10 years from the date of collection when stored at –120º or colder, except when Red Cell Concentrate is prepared for freezing with high glycerol content (40 per cent glycerol), in which case it may be stored at –65º or colder for no later than 10 years from date of collection. If the frozen Red Cell Concentrate is processed for freezing or for thawing, in an open system, the expiration date for the thawed Red Cell Concentrate is 24 hours after removal from –65º storage, provided it is then stored at the temperature of unfrozen Red Cell Concentrate.

Packaging and storage Collect into an approved container containing a sterile, pyrogen-free approved anticoagulant. An approved additive solution may be added after removal of the plasma. Store Red Cell Concentrate in the original container, or transfer to an equivalent container using a technique that does not compromise sterility. Liquid Red Cell Concentrate is stored at a temperature between 2º and 6º. Frozen Red Cell Concentrate is stored at –65º or colder.

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition, the label on the container states (1) the reference number of the donation of the Whole Blood from which the preparation was made; (2) the ABO group and the Rh type of the Whole Blood from which the preparation was made and, where appropriate, the specificities of the antisera used in testing; (3) the nature of the anticoagulant and any additive solutions added subsequent to collection; (4) that the preparation shall not be used if there is any visible evidence of deterioration; (5) the product name as indicated in Table 1; (6) the names of the adventitious agents tested and the results of the tests.

Table 1 Red Cell Concentrate Preparations

Identification

         A. Blood group Determine the blood group, using a separate sample of the donor’s blood, as described in the “Determination of ABO Group of Donors” (Appendix 15.1.1) by examination of both cells and serum.

         B. Rh type Determine the Rh type, using a separate sample of the donor’s blood, as described in the “Determination of Rh Group of Donors” (Appendix 15.1.2) by examinations of the cells.

         Sterility Complies with the “Sterility Test” (Appendix 10.1).

Visual inspection Inspect visually during storage and immediately prior to use. If the colour or physical appearance is abnormal or there is any indication or suspicion of microbial contamination, the unit is unsuitable for transfusion.

Leukocyte count Pipette 40 μl of a suitable red celllysing agent into a clean test-tube, add 100 μl of Red Cell Concentrate diluted with saline TS, if necessary, such that the hematocrit of Red Cell Concentrate is not more than 60 per cent. Mix by pipetting up and down several times. Add 360 μl of a 0.01 per cent w/v solution of crystal violet in a 15 per cent v/v solution of acetic acid into the mixture, and mix thoroughly. Fit a hemocytometer with a 50-μl counting volume and a bright background, with a cover slip, and load the counting chamber with the mixture until the counting area is completely covered, but not overfull. Cover the counting chamber with a suitable moist lid to prevent evaporation, and allow to settle undisturbed for 10 to 15 minutes. Remove the lid, place the chamber on the stage of a light microscope fitted with 10× ocular lens and 20× objective. Count the leukocytes in the entire 50-μl counting volume. Calculate the leukocyte count in Red Cell Concentrate, expressed in leukocytes per μl, by dividing the observed leukocyte count by 10. Calculate the total number of leukocytes in the Red Cell Concentrate unit by using the following formula:

Total leukocytes = leukocytes/μl × 103 × the volume of the Red Cell Concentrate unit in ml.

Adequacy of deglycerolization (for Red Cell Concentrate, Deglycerolized) Interrupt the last wash cycle of the deglycerolization process at a point where the wash fluid is visible in the clear tubing segment leading to the waste receptacle. Hold the tubing against a welllighted, white background. Note the coloration of the fluid in the tubing, and compare it to a suitable hemolysis colour comparator standard. The colour of the fluid should be no stronger than the block indicating 3 per cent hemolysis. (Note If the level of hemolysis is more than 3 per cent, continue the wash process, and repeat the test until the colour is within acceptable limits.)

Hemoglobin Complies with the “Determination of Hemoglobin Concentration by Hemiglobincyanide Method” (Appendix 14.2.3).

 

MONOGRAPHS • RED CELL CONCENTRATE
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หมายเหตุ / Note : TP II 2011 PAGE 189-191