NATIONAL 111S00301 BLOOD COMPONENT DATASHEET WHOLE BLOOD PLASMA REDUCED LEUCOCYTE DEPLETED COMPONENT DESCRIPTION This component is prepared by leucodepleting fresh whole blood and removing a proportion of plasma. It is designed for use for neonatal exchange transfusions and large volume transfusion in neonates but it can also be used for adult transfusion. QUALITY SPECIFICATIONS Volume: Leucocyte Count: Haematocrit: Anticoagulant: CMV Status: High titre anti A or B: 250 – 450 mls (usually 350mls) <5 x 106 per unit 0.45 – 0.55 CPD On demand* Negative Supernatant Hb: Fibrinogen: Factor VIIIc: Platelet Count: pH at out date: N/A N/A N/A N/A N/A *Components for neonatal exchange transfusion should be CMV negative. USES To increase tissue oxygenation, when this is critically reduced by either loss of blood or anaemia of other origin. This is the product of choice for neonatal exchange transfusion. DOSAGE AND ADMINISTRATION Dosage Dosage depends on the clinical need of the patient and it must be adjusted accordingly. Neonatal Exchange Transfusion: Indicated in infants born with clinically significant anaemia with or without hyperbilirubinaemia due to haemolytic disease of the newborn or other causes. Only units less than 5 days old should be used for this purpose. Anaemia: A transfusion of 4-5 ml per kg will increase the circulating haemoglobin by about 10 g/l. Administration Prepared by: Susanta Ghosh Authorised by: Peter Flanagan QA Approved by: Nick Smith Effective Date: 11/01/02 Copy No: Page 1 of 3 File Name: 111S00301 Previous Name: N/A NATIONAL 111S00301 Blood to be transfused must be tested to ensure compatibility with patient’s serum except in life threatening emergencies. For neonatal exchange transfusions it should be compatible with neonatal serum and maternal serum if available. It must be transfused intravenously through a blood giving set with an in-line, 170-200 micron filter. If a syringe is used it should be filled through a filter assembly. Patient’s vital signs should be monitored during the transfusion. In cases where large volume of transfusion is given in a short time or where recipient’s plasma contains significant cold acting antibodies, a blood warmer should be used. Otherwise this preparation can be transfused without warming. The transfusion rate depends on the clinical need but transfusion of each unit should be completed within 4 hours. Transfusion of every unit of red cells must be preceded by adequate checking procedures that ensure the unit to be transfused has been issued for the patient who is to receive it and that the integrity of the bag has been maintained. It is a legal requirement that all details of the blood component which is infused are documented in the patient’s notes (eg, product pack number, ordering medical officer, duration of infusion, given by, checked by, time started). CONTRAINDICATIONS, WARNINGS, ADVERSE REACTIONS Contraindications Red cells must be transfused with extreme caution in patients with expanded plasma volume, heart failure or with hyperviscosity states. Cellular blood products should be irradiated before transfusion for patients with profound cellular immune-deficiency or those receiving a transfusion from genetically related donors. Warning Acute transfusion reactions may occur if incompatible, wrongly stored or bacterially contaminated red cell preparations are transfused. Non-haemolytic transfusion reactions can present as urticaria, fever and rarely as anaphylaxis. Symptoms include chills, rigors, fever, chest tightness and hypotension. The transfusion should be stopped immediately and the cause investigated. The implicated component together with the recipient’s blood sample should be returned to the blood bank. Adverse Reactions These may be immediate or delayed. Immune: Transfusion of ABO incompatible blood may result in acute and severe haemolysis with shock. Transfusion of red cells may lead to immunisation to red cell antigens. When this happens, difficulties may arise in providing compatible blood for later transfusions. Antibodies not detectable at compatibility testing may cause haemolysis some days after transfusion. On rare occasions such haemolysis may be acute. Transfusion of red cells that lead to immunisation to Rh(D) or other red cell antigens may cause or aggravate haemolytic disease of the newborn in subsequent pregnancies in female patients. Prepared by: Susanta Ghosh Authorised by: Peter Flanagan 111S00301 QA Approved by: Nick Smith Effective Date: 11/01/02 Copy No: Page 2 of 3 File Name: Previous File: N/A NATIONAL 111S00301 Immunisation to leucocyte antigens and platelet antigens can make the patient refractory to subsequent platelet transfusions. Immunisation to platelet antigens can also cause thrombocytopenia in susceptible individuals. Immunisation to various other non-red cell antigens is associated with non-haemolytic transfusion reactions. Cytokines present in stored blood also can cause non-haemolytic transfusion reactions. These complications are rather infrequent with leucodepleted red cell preparations. Transfusion related lung injury might occur if antibodies to recipient’s granulocytes are present in donor plasma. Transfusion of non-irradiated red cells can cause graft versus host disease in patients with cellular immune-deficiency or if transfused to a genetically related patient. Haemodynamic: overload. Transfusion of excessive volumes may lead to circulatory Metabolic: Rapid transfusion of large volume of red cells may lead to hypothermia or hyperkalaemia. Transfusion of stored red cells may effect acid base balance in critically ill patients. Hypokalaemia may arise about 24 hours after a large volume transfusion. Infective: Every care is taken in donor selection and in blood collection, processing and storage but there is a small but definite risk of transmitting bacterial, viral and other infections. Reaction due to bacterially contaminated red cells usually develops within minutes and consists of chills, rigors, fever, nausea, vomiting, abdominal and muscle pains, hypotension, haemoglobinaemia and DIC. Recipients showing signs and symptoms consistent with a septic reaction should be treated for septic shock before laboratory results are available. Appropriate support for haemostatic failure may be required. STORAGE AND PRECAUTIONS Store at +2 °C to +6 °C. Do not use if the bag is damaged, if the product is discoloured, or if there is a clot present. No drugs or additives other than 0.9 % Sodium Chloride intravenous infusion may be mixed with red cells before or during transfusion. Discard all used or partially used bags. All unused bags should be returned to the Blood Bank. Avoid skin contact with this preparation. FURTHER INFORMATION Each unit conforms to the NZBS specification for donor selection and collection procedure. Each unit has tested negative for HBsAg, Anti-HIV-I and -II, anti-HCV and Syphilis. This component has also tested negative for HCV and HIV RNA using NAT method. Prepared by: Susanta Ghosh Authorised by: Peter Flanagan 111S00301 QA Approved by: Nick Smith Effective Date: 11/01/02 Copy No: Page 3 of 3 File Name: Previous File: N/A