Single-donor platelet concentrate, volume-reduced

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'

E7021VC0

E7021VD0

 

NIHDI Code

Hospitalized: 752 500

Non-hospitalized: 752 496

Preparation and composition

A one-donor platelet concentrate, pathogen-reduced is selected as the starting product for volume reduction.

From this, 3 EEE (Single Unit Equivalent) are separated and centrifuged. The volume of the above mixture of plasma and storage solution (PAS) is then reduced to a maximum of 25 ml per unit (EEE). This corresponds to a concentration of minimum 2 x106/µl.

Indications

Severe thrombocytopenia or thrombocytopathy in a newborn at risk of circulatory overfilling, or when a larger platelet dose is desired than can be administered in the volume of a normal platelet concentrate.

 

Contraindications

Het gebruik van bloedplaatjesconcentraten is gecontra-indiceerd bij patiënten met een voorgeschiedenis van allergische reacties op amotosalen of psoralenen. Bloedplaatjesconcentraten dienen niet te worden voorgeschreven aan neonatale patiënten die behandeld zij met fototherapie-apparaten die een piekgolflengte van minder dan 425 nm afgeven, en/of een lagere limiet van de emissiebandbreedte van <375 nm hebben. 

Dose and instructions for use

Dose

A dose of 5 ml/kg volume-reduced platelet concentrate increases platelet count by approximately 40 000/µl.

To evaluate the efficiency of a platelet transfusion in a comparable manner at different doses and individuals, the corrected count increment (CCI) can be calculated. The CCI represents, for a given individual, and at an assumed body surface area of 1m2, the increase in platelet concentration (in103/µl) after transfusion of 1x1011 platelets.

            

CCI = ([PLT]* 1 hour after transfusion - [PLT]* before transfusion) x body surface area** x1011

                                    number of platelets administered

  

Body surface area** = √ (length°x weight°°/3,600)

  

(* thrombocyte count expressed as103 per µl)

(** body surface area in m²)

(°length in cm)

(°°weight in kg)

 

CCI is calculated from the platelet count 10 to 60 minutes after transfusion (1-hour CCI) or from the platelet count 24 hours after transfusion (24-hour CCI).

With fever, sepsis, hypersplenism, diffuse intravascular coagulation, massive bleeding and use of certain antibiotics, the yield is usually low.

A 1-hour CCI value below 7,000/µl in the absence of the above factors may indicate neonatal allo-immune thrombocytopenia. If possible,HPA-compatible single-donor platelet concentrates are then administered.

Special precautions

No cross-matching is required. Platelets are preferably administered ABO-compatible; for small children and for repeated transfusions, ABO compatibility of the plasma is also important and ABO-identical platelets are recommended. If these are not available, type O platelets without the indication "isogroup only" can be used. Type O platelets marked 'isogroup only' should only be administered to type O patients.

Resus D-negative recipients are preferably treated with platelets from rhesus D-negative donors. If platelets from rhesus D-positive donors are still used for female rhesus D-negative patients, rhesus D immunization should be prevented by administration of anti-resus D immunoglobulins (a dose of 50 µg i.m. provides protection when transfusing rhesus D-positive platelet concentrates for several weeks).

User Manual

A platelet concentrate is administered intravenously through a perfusion set with standard filter (170-260 µl). The platelets are infused slowly for the first 10 to 15 minutes while the patient is closely observed for any transfusion reaction. Then the infusion rate is increased according to clinical condition. The transfusion never lasts longer than 4 hours. Aseptic technique must be used during administration.

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 due to plasma incompatibility and severe allergic reactions such as anaphylactic shock.

Further occurrences may include: posttransfusion purpura, chemical disruption in massive transfusion (citrate toxicity), 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.

If an acute transfusion reaction occurs, transfusion should be stopped immediately and appropriate symptomatic therapy initiated.

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

A platelet concentrate should not be mixed with drugs or infusion solutions.

Preservation and stability

Platelets should be stored under conditions that maintain optimal viability and hemostatic activity. A platelet concentrate is contained in an oxygen-permeable storage bag and should be stored on a shaker with movement in a horizontal plane. The storage temperature for a platelet concentrate is between + 20 °C and + 24 °C. The storage time is 6 hours. A platelet concentrate should not be used after the expiration date and with signs of damage or deterioration.

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.

The residual risk - after donor selection and lab testing - of transmission of HIV, HBV and HCV was estimated at 1 in 4 to 6 x106, 1 in 0.3 to 6 x106 and 1 in 700,000, respectively, and is mainly due to the "window period" for lab detection. This residual risk is reduced to almost zero by PR. This residual risk is reduced to near zero by PR. Because of its broad action spectrum, PR also protects to a significant extent against transmission of lesser or unknown pathogens ("emerging infectious diseases"). However, such transmission can never be excluded.

The risk of bacterial contamination of PLC is very much reduced by PR. Sterility control on PLC is therefore no longer performed.

Prions are not eliminated by PR and cannot be detected in donors by routine lab tests. Protection against transmission of prions by transfusion relies on careful donor selection.

 

Episode

By medical prescription, after order.

Order at least 24 hours before the desired delivery time.

                                                                                                                                                                         

Last updated 11/04/24.