Erythrocyte concentrate, frozen and thawed

This product data sheet describes a patient-specific blood product that is only prepared to order in the context of specific indications. It is intended for a specific patient and is requested through a separate ordering procedure with the order form for patient-specific blood products. To ensure timely delivery, it must be ordered 24 hours in advance.

Product Codes

Code 'Blood Service'

Not irradiated:

E6124V00

E6124VA0

Irradiated:

E6116V00

E6116VA0

 

NIHDI Code

Hospitalized: 752 463

Non-hospitalized: 752 452

Preparation and composition

By additional processing, a de-ukocyzed erythrocyte concentrate of a particular phenotype can be prepared for long-term frozen storage. A glycerol solution is added to the erythrocyte concentrate, which is then frozen at - 80 °C or below. Upon thawing, the erythrocytes are deglycerolized in a closed system and finely re-suspended in preservative solution (SAGM).

A thawed erythrocyte concentrate has a hematocrit between 0.35 - 0.60 and contains at least 36 g of hemoglobin. The volume is at least 185 ml and is printed on the release label.

Depending on the year of donation, the frozen and thawed erythrocyte concentrates are deleukocyzed or not. Deleukocyzed erythrocyte concentrates contain less than 1 x106 leukocytes/product.

If desired, the product is irradiated. The irradiation dose is not less than 25 Gray and not more than 50 Gray. Irradiation is performed after thawing.

 

Indications

A frozen and thawed erythrocyte concentrate is used to treat severe blood loss and/or anemia in patients with a special phenotype for whom no compatible blood in the form of a standard erythrocyte concentrate is available.

 

Dose and instructions for use

Dose

Transfusion of one erythrocyte concentrate increases the hemoglobin concentration in a 70-kg person not actively bleeding by an average of 1 g/dl and the hematocrit value by ± 3%.

Special precautions

In transfusion of an erythrocyte concentrate, compatibility between donor and recipient must be ensured by selection of an erythrocyte concentrate compatible with the ABO and rhesus D blood type of the recipient, negative for the blood group antigens to which the patient has antibodies, and by performance of a cross-test between donor red blood cells and recipient serum. To confirm the suitability of the selected product, a cross-test is performed before thawing on a pilot sample of the frozen erythrocyte concentrate by the reference laboratory of Belgian Red Cross-Flanders. The actual compatibility between the thawed product and the recipient should be ensured by cross-testing at the requesting hospital.

If intended for severely immunocompromised patients, the product should be irradiated.

User Manual

Aseptic technique should be used during the duration of the transfusion. Delivery sets and filters should be replaced in a timely manner in case of multi-unit transfusion. The erythrocyte concentrate is administered intravenously via a perfusion set with standard filter (170-260 µ).

For the first 10 to 15 minutes, a low infusion rate is set and the patient is closely observed for any transfusion reaction. Then the infusion rate is increased according to the clinical condition. The average transfusion duration of an erythrocyte concentrate is 1 to 2 hours. It is recommended that the duration for transfusion of one unit be limited to a maximum of 4 hours.

Any residues are disposed of as medical waste.

 

Possible undesirable effects when the product is administered

The most frequent side effects of blood product transfusion are chills, fever and symptoms of an allergic nature such as urticaria and itching.

Serious, potentially fatal, adverse reactions include: circulatory overfilling with pulmonary edema, transfusion-related acute lung disease (TRALI), bacterial sepsis,

hemolytic transfusion reaction and severe allergic reactions such as anaphylactic shock.

Further occurrences may include: chemical disturbance in massive transfusion (hyperkalemia) and transfusion-associated graft versus host disease (TA-GVHD).

Through blood and blood derivatives, infections can be transmitted: with viruses (B19 parvovirus, CMV*, HAV, HBV, HCV, HIV,...), with bacteria (syphilis), with protozoa (malaria, leishmania, trypanosomiasis) and with unknown pathogenic agents.

Iron accumulation may occur with frequent transfusions or transfusions over a long period of time.

If an acute transfusion reaction occurs, transfusion should be stopped immediately and appropriate therapy initiated. The following laboratory tests may be useful in severe reactions: hemolysis parameters (haptoglobin, free hemoglobin, LDH, bilirubin), repeat cross-matching and blood group determination of patient and product, direct antiglobulin test, serum IgA, patient's hemoculture and bacteriological examination of the administered unit.

In case of a mild allergic transfusion reaction (itching, redness, urticaria), the transfusion can be continued if necessary after administration of antihistamines or corticosteroids.



* Deukocyte-derived blood products are generally believed to virtually eliminate the possibility of CMV virus transmission due to elimination of the white blood cells. For indications of the use of blood products derived from donors serologically negative for CMV: see under CMV-negative blood products.

Medication and other interactions

The erythrocyte concentrate should not be mixed with drugs or infusion fluids. Physiological saline solutions may be administered along with blood, but not added to the blood bag.

Preservation and stability

A frozen and thawed erythrocyte concentrate should be administered within 24 hours of preparation. It is stored between + 2 °C and + 6 °C.

An erythrocyte concentrate should not be used with signs of damage or decay.

Safety of products prepared from human whole blood

Blood is drawn from voluntary, non-remunerated donors, selected in accordance with the standards laid down by Belgian legislation and the procedures of the Blood Service of Belgian Red Cross-Flanders.

With each donation, the donor is inspected by a physician and tested for antibodies against the human immunodeficiency viruses (anti-HIV-1 and HIV-2), for antibodies against the hepatitis C virus (anti-HCV), for the hepatitis B virus surface antigen (HBsAg) and for antibodies against Treponema pallidum. HIV, HBV and HCV are also detected by NAT testing.
Products from donations with positive test results are destroyed.

When products prepared from human blood are administered, transmission of an infectious agent cannot be completely excluded. The residual risk of transmission of HIV, HBV or HCV by unit transfusion is estimated at 1 in 4 to 6 x106, 1 in 0.3 to 1 x106 and 1 in 700,000, respectively.

Transmission of as yet unknown pathogens cannot be ruled out.

 

Episode

By medical prescription, after order in patient's name.

Order at least 24 hours before the desired delivery time.

                                                                                                                                                                             

Last updated 11/04/24.