Centrul național de transfuzie a sângelui

Erythrocyte concentrate


 

 

    

A blood component obtained from whole blood by removing some of the plasma, without any other changes. Its properties include, for each unit, hematocrit of 0.65 - 0.75, minimum of 45 g Hb at the end of the storage period. The product contains all the red cells in the unit of origin. Contains no more than 0.8% free haemoglobin at the date of expiry. Prepare this blood product by separating plasma from the whole blood unit after centrifugation.

    During storage the temperature of the blood component must remain between +2° and +6°C. The shelf life depends on the anticoagulant/preservative solution used: CPD shelf life is 28 days, CPD-A1 shelf life is 35 days, CPD -Mannitol or CPD + SAGM shelf life is 42 days).

    Validated transport systems will guarantee that at the end of a transport circuit of maximum 24 hours, the temperature will not exceed +10°C. In case of transport by vehicles without refrigeration, an insulated and cooled container must be used.

 

       b) Red blood cell leucocyte concentrate

     Blood-derived component obtained from blood by separating part of the plasma and leukocyte layer from the red cell concentrate. The haematocrit of this derived component will be 0.50 - 0.70. The product contains all but 10-30 ml of the red cells in the unit of origin. Each unit must contain a minimum of 43 g Hb/un. The leukocyte content is less than 1,2 x 109 cells/unit, the haemolysis at the end of storage shall be greater than 0,8 % of the erythrocyte sediment.

     To prepare this derivative, plasma and 20 - 60 ml of the leukocyte layer of the red cell unit are separated after centrifugation. Sufficient plasma is returned to the erythrocyte unit to give a haematocrit of 0,50 - 0,70.

     The storage process will be as for the red cell concentrate. Validated transport systems shall ensure that at the end of a transport of maximum 24 hours, the temperature does not exceed +10°C. In case of transport by vehicles without refrigeration, an insulated and cooled container must be used.

        

c) Displaced erythrocyte concentrate

Blood derivative component obtained from centrifuged whole blood, eliminating the plasma, the red blood cells being subsequently washed in an isotonic solution. This derivative is a suspension of red blood cells from which most of the plasma, leukocytes and platelets have been extracted. The hematocrit will be 0.65 – 0.75. Each unit must contain a minimum of 40 g/unit of hemoglobin at the end of the preparation procedure. Hemolysis at the end of storage will be no more than 0.8% of the sediment.

It is prepared by centrifugation and the extraction, as complete as possible, of the plasma and the leuco-platelet layer, the red blood cell concentrate is centrifuged in several rounds, preferably at a temperature of +4°C, after it has been added each time a cold isotonic solution (its temperature being +4°C). Operations can be performed in a closed functional system, using sterile connections.

The product must be stored at a temperature of +2°C to +6°C. The preservation period must be as short as possible after washing and must not, in any case, exceed 24 hours, if the preparation was carried out at low temperatures. The preservation time should not exceed 6 hours, if the preparation was made at room temperature.

The possibilities of transport are limited by the short preservation period. The preservation conditions will be kept constant during transportation. The observance of temperature and duration must be strictly observed.

 

d) Platelet concentrate

Depending on the preparation method, the concentration of platelets on a single unit is between 45 – 85 x 109, the suspension medium being 50 – 60 ml. Similarly, the leukocyte concentration will be no more than 0.05 x 109 and the erythrocyte concentration is no more than 0.2 x 109 per unit, unless further steps are taken to reduce these numbers.

The platelet concentrate must be kept in optimal conditions, which ensure their survival and hemostatic activity. Platelet concentrate can be stored in plasma.

The amount of oxygen required depends on the concentration of platelets in the product. Adequate storage is achieved at a permanent pH of the platelet product between 6.4 - 7.4 during storage. During preservation, the platelets must be agitated with sufficient effectiveness, to ensure their oxygen intake, proceeding as gently as possible at the same time. The storage temperature must be between + 20°C and +24°C. The maximum storage time of the platelet concentrate is 5 days.

 

e) Granulocyte concentrate

Blood component obtained from a unit of whole blood, collected from a donor, whose suitability for donating blood is ascertained by a medical certificate. The number of granulocytes/granulocyte concentrate unit must be greater than 10 x 109. The corrected pH value at + 22°C, measured at the end of the shelf life, is between 6.4 and 7.4.

The granulocyte concentrate should be transfused as soon as possible after collection. If its storage cannot be avoided, the preservation period must be limited to a maximum of 24 hours, at a temperature between +20°C and +24°C.

The granulocyte concentrate must be transported in a container adapted to the preservation temperature between +20°C and +24°C.

 

f) Fresh frozen plasma

Component for transfusion or fractionation, prepared from whole blood or from plasma collected by apheresis, frozen for a time and at a temperature that maintains the labile coagulation factors in a functional state. This component contains, at normal plasma values, stable coagulation factors, albumin and immunoglobulins. It must contain, on average, no less than 50g/l of the total protein concentration in accordance with the limit established by the European Pharmacopoeia 0853EC Directive 2004/33EC. It also contains, on average, no less than 70 IU of factor VIII per 100 ml and at least similar amounts of other labile coagulation factors, as well as natural inhibitors present. Residual cells: the erythrocyte content will be no more than 6 x109 /l, the leukocyte content will be no more than 0.1 x109 /l, the wafer content will be no more than 50 x109. If fresh frozen plasma serves as raw material for the preparation of biomedical products from blood, the reference documentation in this regard is the European Pharmacopoeia. The freezing process must be initiated within the first 12 hours after the completion of the collection procedure (by apheresis or separation from the whole blood unit) in a system that allows full freezing for one hour at a temperature below -30ºC.

Stability depends on available storage temperature. The optimal storage temperature is equal to or lower than - 25°C; the authorized storage duration and temperature are as follows: 36 months below -25°C or 3 months between -18°C and -25°C.

The storage temperature must be maintained during transport.

After defrosting, the product is used immediately. Refreezing is prohibited.

 

g) Antistaphylococcal fresh frozen plasma

Component for transfusion or fractionation, prepared from whole blood or plasma collected by apheresis from donors previously immunized with antistaphylococcal toxoid, frozen for a time and at a temperature that maintains the labile coagulation factors in a functional state .

Stability depends on available storage temperature. The optimal storage temperature is equal to or lower than -25°C; the authorized storage duration and temperature are as follows: 36 months below -25°C or 3 months between -18°C and -25°C.

The storage temperature must be maintained during transport.

After thawing, the product is used immediately. Refreezing is prohibited.

 

h) Cryoprecipitate

Component containing plasma cryoglobulins, obtained from fresh frozen plasma and prepared from fresh frozen plasma, acellular and concentrated to a final volume of 10 – 20 ml. It contains most of factor VIII, Willebrand factor, fibrinogen, factor XIII and fibronectin, present in freshly collected and/or separated plasma. Each unit will contain factor VIII not less than 70 IU per unit and fibrinogen not less than 140 mg per unit.

Stability depends on available storage temperature. The optimal storage temperature is equal to or lower than - 25°C; the authorized storage duration and temperature are as follows: 36 months below -25°C or 3 months between -18°C and -25°C.

The transport and thawing conditions are analogous to those of fresh frozen plasma.

 

j) Fresh frozen, decryoprecipitated plasma

Component prepared from plasma by removal of cryoprecipitate. The content in albumin, immunoglobulins and coagulation factors of the product is identical to that of fresh frozen plasma, except for the labile factor V and factor VIII, with a net low value. The concentration of fibrinogen is also lower than that of fresh frozen plasma. Decryoprecipitated plasma must not contain clinically significant irregular antibodies. The quality control parameter is the specified volume ± 10%.

De-cryoprecipitated plasma is a secondary product, obtained in the process of preparing cryoprecipitate from fresh frozen plasma. Stability depends on available storage temperature. The optimal storage temperature is equal to or lower than -25°C; the authorized storage duration and temperature are as follows: 36 months below -25°C or 3 months between – 18°C ​​and – 25°C.

The storage temperature must be maintained throughout transportation.

 

k) Concentrated fresh-frozen, decryoprecipitated plasma

Component prepared from plasma by removal of cryoprecipitate. The content of albumin, immunoglobulins and coagulation factors of the product is identical to that of fresh frozen plasma, concentrated to a lower concentration of plasma, except for the labile factor V and factor VIII, with a net low value. The concentration of fibrinogen is also lower than that of fresh frozen plasma. The quality control parameter is the concentration of plasma proteins, their level will not be lower than 75g/l.

Concentrated decryoprecipitated plasma is a secondary product, obtained in the process of preparing cryoprecipitate from fresh frozen plasma, removing the saline solution from the primary plasma unit. Stability depends on available storage temperature. The optimal storage temperature is equal to or lower than -25°C; the authorized storage duration and temperature are as follows: 36 months below -25°C or 3 months between -18°C and -25°C.

The storage temperature will be maintained throughout the transportation.