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ACD Whole Blood; CPD Whole Blood; CPDA-1 Whole Blood; Heparin Whole Blood.

Category Human blood and blood products.

         Whole Blood is blood that has been mixed with a suitable anticoagulant. The blood is obtained from a counselled healthy donor who must, as far as can be ascertained after medical examination, laboratory tests and a study of the donor’s medical history, be free from detectable agents of infection transmissible by transfusion of blood or blood components. The examinations and tests to be carried out are decided by the National Blood Centre and Ministry of Public Health. Tests for syphilis, for hepatitis B surface antigen (HBsAg), for hepatitis C antibodies (antiHCV) and for HIV antigen and antibodies (anti-HIV-1 and anti-HIV-2) and nucleic acid test (for HBV, HCV, HIV) are carried out by suitably sensitive methods and must give non-reactive results in all cases.

         The blood has a hemoglobin value, in terms of the National or International Standard for Hemiglobincyanide, of not less than 12.5 per cent w/v. The blood is withdrawn aseptically through a closed sterile system consisting of a tube connecting the needle inserted in a donor’s vein into a suitable, sterile plastic container holding one of the Anticoagulant and Preservative Solutions for Blood in a specific amount not exceeding 22 per cent v/v of the final volume of the mixture. No antimicrobial preservative is added. Requirements and advice concerning the container are given in Appendix 11.3. When withdrawal is complete, the container is sealed immediately so as to exclude micro-organisms and cooled at 2º to 6º. Firmly attached to each container is a smaller container with a small quantity of the blood for compatibility and other tests. The final mixture of blood and anticoagulant solution has a hemoglobin value in terms of the National or International Standard for Hemiglobincyanide of not less than 9.7 per cent v/v (calculated from the hemoglobin value of the donor’s blood and the dilution due to the anticoagulant solution).

Description Deep red fluid which, on standing, separates into a lower layer of sedimented red cells and a yellow, upper layer of plasma free from signs of hemolysis. A layer may be visible between the two, appearing as a whitish film of white cells and platelets.

Dose Intravenous infusion, as needed to replenish blood volume; usually 1 Unit1 , repeated as necessary. The dose is based on the estimated blood loss, laboratory determination of need or central venous pressure. Units must be administered through a 170 to 200 μm filter.

Warning

1. The rapid transfusion of large volumes of whole blood may overload the circulation and cause pulmonary edema.

2. Repeated transfusion of blood, as in thalassemia, may lead to iron overload.

3. Disseminated intravascular coagulation may also occur in patients receiving large-volume transfusion.

¹ One unit is 450±45 ml of whole blood to which 63 ml of ACD, CPD or CPDA-1 solution has been added. 

4. Group O blood samples whose sera show the presence of hemolysins should not be transfused to recipients of other groups.

Expiration date The expiration date depends on the anticoagulant used as follows:

ACD Whole Blood and CPD Whole Blood not later than 21 days.

CPDA-1 Whole Blood not later than 35 days.

Packaging and storage Whole Blood shall be stored at a temperature of 2º to 6º.

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition, the label on the container states (1) the ABO group; (2) the Rh group and the nature of specific antisera used in testing; (3) the total volume of fluid, the proportion of blood and the composition and volume of anticoagulant solution; (4) a means whereby the individual source of the blood may be identified; (5) the date on which the blood was withdrawn; (6) that the contents shall not be used if there is any visible evidence of deterioration; (7) that the tests for HBV, HCV and HIV were non-reactive in all tests; (8) that a serologic test for syphilis was nonreactive; (9) for blood of group O, that the blood is for transfusion only to recipients belonging to group O unless the absence of hemolysins has been demonstrated.

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 (for units labelled as Whole Blood, Leukocytes Reduced) Proceed as directed under Red Cell Concentrate, p. 191, except to use 100 μl of Whole Blood.

Hemolysins Add 1 volume of fresh donor serum to 1 volume of a 10 per cent v/v suspension of A₁ cells in saline TS and add 1 volume to 1 volume of a similar suspension of B cells; a similar test using O cells is carried out as a negative control. If the serum is more than 24 hours old, add 1 volume of fresh group O serum free of lysins to each tube as a source of complement. Mix the contents of each tube, incubate at 37º for 1 hour and examine the supernatant liquid for hemolysis.

A serum giving a positive result in this test should be further examined as follows.

Dilute 1 volume of the serum with 3 volumes of saline TS and mix 1 volume of the diluted serum with 1 volume of fresh group O serum free of lysins and 1 volume of a 10 per cent v/v suspension, in saline TS, of A₁ or B cells (whichever were lysed in the first test). At the same time, in two further tubes, mix 1 volume of saline TS with 1 volume of the fresh group O serum free of lysins. To one of these tubes add 1 volume of a 10 per cent v/v suspension of A₁ cells in saline TS and to the other 1 volume of a similar suspension of B cells. Incubate the tubes for 1 hour at 37º, mix the contents of each tube and examine the supernatant liquid for hemolysis. Group O blood samples whose sera show the presence of hemolysins should be regarded as unsafe for transfusion to recipients of other groups and must be labelled accordingly.

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