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Informed consent for blood product transfusions

  • 1. Purpose and scopeÌý

    The purpose of this document is to provide a framework for clinicians prescribing blood products for children at The Royal Children’s Hospital (RCH).

    Please refer to the Blood Transfusion – Fresh BloodÌý Products Procedure and the Consent – Informed Procedure.

    2. DefinitionsÌý

    Term / Abbreviation ·¡³æ±è±ô²¹²Ô²¹³Ù¾±´Ç²ÔÌý
    ÌýFresh blood components Red cells, platelets, fresh frozen plasma, cryoprecipitate
    Ìý¹ó¹ó±Ê Fresh frozen plasmaÌýÌý
    Ìý±áµþ³Õ Hepatitis B virusÌýÌý
    Ìý±á°ä³Õ Hepatitis C virusÌý
    Ìý±á±õ³Õ Human immunodeficiency virusÌýÌý
    Ìý±õ³Õ±õ²µ Intravenous ImmunoglobulinÌýÌý
    ÌýPlasma-derived blood components (batched)Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý ÌýÌý Albumin, IVIg, Beriplex, Biostate, Riastap (Fibrinogen concentrate)Ìý
    ÌýSCIg Ìý Subcutaneous immunoglobulinÌýÌý


    3. GuidelineÌý

    3.1 Consent discussionÌý

    Blood transfusions are used to treat blood loss or to supply blood components that the body cannot make itself and has the potential to be lifesaving. Valid informed consent must be obtained and documented prior to transfusion of blood products and/or plasma-derived blood components.

    The decision to transfuse a patient should be a carefully considered decision and involve a discussion with the patient, parent/legal guardian, providing the patient, parent/legal guardian with information and provide them with an opportunity to ask any questions and use an interpreter for non-English speaking families.Ìý

    The following should be part of the consent discussion:

    • The type of blood product (e.g., red cells)
    • The clinical indication for the blood product transfusion (e.g., severe anaemia)
    • The possible benefits of the transfusion
    • The possible risks associated with a transfusion
    • The risks of refusing a transfusion
    • Any alternatives to transfusionÌý

    3.2 Types of blood products and benefitsÌý

    Type of blood product (fresh)ÌýÌý ÌýPossible benefits and / or indicationÌý
    ÌýRed cellsÌý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý ÌýÌý ÌýRelieve symptoms of anaemia (fatigue, lethargy)
    ÌýIncrease oxygen carrying capacity to organs and tissues
    Ìý±Ê±ô²¹³Ù±ð±ô±ð³Ù²õ

    Ìý

    May prevent or treat bleedingÌý Ìý Ìý

    Ìý¹ó¹ó±Ê
    ÌýCryoprecipitate
    ÌýGranulocytes Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý Ìý ÌýÌý ÌýMay help treat infection
    ÌýType of blood product (batched)ÌýÌý ÌýPossible benefits and / or indicationÌý
    ÌýAlbumin 5% and 20% ÌýUsed to treat or prevent shock, treat hypovolaemia and used to replace low albumin levels.
    ÌýSCIg ÌýUsed to replace low levels of immunoglobulins and prevent infection or used as an immunomodulatory agent.

    ÌýPlasma derived clotting factorsÌý

    (e.g., Beriplex, Biostate, Riastap – fibrinogen concentrate) Ìý Ìý

    ÌýUsed to replace low clotting factor levels

    ÌýAntithrombin IIIÌý ÌýUsed to replace low antithrombin levels and prevent thrombosis.Ìý
    ÌýRh(D) immunoglobulinÌý ÌýUsed to prevent RhD sensitisation in RhD negative patients during pregnancy or following an RhD positive transfusion.Ìý
    ÌýOther immunoglobulins
    Ìý(e.g., CMV immunoglobulin, Hepatitis B immunoglobulin, Tetanus immunoglobulin, Zoster immunoglobulin, Normal Human immunoglobulin)Ìý Ìý
    ÌýMay be used to prevent or treat infection in naïve patients following potential infection-exposure.Ìý


    3.3 Risks associated with transfusionÌý

    Australia has one of the safest blood supplies in the world and blood transfusions in Australia are usually very safe. Blood donors are voluntary and non-remunerated. Blood donations are obtained, tested, handled and stored very carefully. Each blood donation is test for HIV, Hepatitis B, Hepatitis C, malaria and syphilis.

    There is a small chance that some patients experience complications, most side effects experienced and mild and self-limiting e.g. fever or a rash and are easily managed by stopping the transfusion.

    See table below for some of the risks related to transfusion:

    ÌýType of complicationÌý ÌýAdverse eventÌý ÌýApproximate incidence
    ÌýMild reaction ÌýFeverÌý Ìý0.1% to 1%Ìý
    ÌýRash or urticaria (mild allergic)Ìý Ìý1 - 3 %Ìý
    ÌýSevere allergic reactionÌý Ìý Ìý Ìý Ìý Ìý Ìý Ìý ÌýÌý ÌýAnaphylaxisÌý Ìý1:20,000 - 1:50,000
    ÌýInfection Ìý ÌýBacterial infection

    Ìý1:250,000 (platelets)

    Ìý1:2.5 million (red cells)Ìý

    ÌýViral infectionÌý

    <1:1 million (HIV)

    <1:1 million (HBV)

    <1:1 million (HCV)

    ÌýRespiratoryÌý Ìý ÌýTransfusion-associated circulatory overload (TACO) Ìý1%
    ÌýTransfusion related acute lung injury (TRALI) Ìý1:1,200 - 1:190,000
    ÌýHaemolyticÌý Ìý Ìý ÌýAcute haemolytic reaction Ìý1:76,000
    ÌýDelayed haemolytic reaction Ìý1:2,500 – 1:11,000
    ÌýAntibody formation Ìý1% (red cell antigens)
    Ìý10% (HLA antigen)
    ÌýIron overload ÌýRequiring chelation ÌýMay occur after >20 red cell units


    For further information see Australian Red Cross Lifeblood websites for more informationÌý

    3.4 Risks of not having a transfusionÌý

    Choosing not to have a blood transfusion may have serious consequences in certain situations including death or disability. Being fully informed about a blood transfusion, includes understanding the consequences of not having the suggested transfusion in the patient’s circumstances.Ìý

    3.5 Possible alternatives to transfusionÌý

    Blood productÌý ÌýPossible alternative to transfusionÌý Ìý Ìý Ìý Ìý ÌýÌý
    ÌýRed cells ÌýIron therapy (oral/IV), haematinics (B12/folate), cell salvage (surgery), erythropoietin- stimulating agents.
    ÌýPlasmaÌý ÌýFactor concentrates if applicable or tranexamic acid
    Ìý±Ê±ô²¹³Ù±ð±ô±ð³Ù²õÌý ÌýTranexamic acid


    3.6 Patient and family informationÌý

    Information on blood product transfusion will be offered to the patient, parents/legal guardians.

    Provision of information must be documented on the Blood eConsent form or the paper based MR634/A form in the event of an EMR downtime.

    ÌýOrganisationÌý ÌýResources - patient and family informationÌý
    ÌýRoyal Children's Hospital - KidsÌýHealth Info fact Sheets Ìý

    ÌýBlood product transfusionÌý

    ÌýIntravenous immunoglobulin (IVIg) infusionÌý
    ÌýAustralian Red Cross Lifeblood Ìý
    Ìý
    Ìý
    ÌýVictorian Department of Health - Bloods Matters program
    ÌýSouth Australia BloodSafe programÌý Ìý


    3.7 Documentation of blood transfusion consent

    Transfusion consent should be sought prospectively prior any blood product transfusion. The only exception is a critical bleeding event where consent should be sought retrospectively.

    The RCH records consent for blood transfusion on the Blood eConsent form. In the event of an EMR downtime the paper-based Ìýshould be used.ÌýA copy of this paper based form should be kept at the patient’s bedside until they are discharged. The original signed form should be sent to HIS for scanning. Ìý

    The RCH surgical consent form does not include a section on transfusion consent and if a blood transfusion may be required during the surgical procedure, the Blood eConsent form must be completed with the family prior to surgery.

    The Blood eConsent form should be sighted by medical and nursing clinicians prior to the prescription and administration of blood products.

    3.8 Clinical indication for blood transfusion and specific blood products consentedÌý

    Record the clinical indication for transfusion on the Blood eConsent form. This may be related to the admission or the specific clinical condition.Ìý

    Record the specific blood products the family/patient have consented to receive on the Blood eConsent form. Clinical staff ensure these are included on this form prior to transfusion of any prescribed/ordered blood products.Ìý

    The Blood eConsent form requires renewal if the clinical condition changes or the blood product prescribed/ordered is not included on the Blood eConsent form.Ìý

    3.8 Duration of blood transfusion consentÌý

    Blood product transfusion consent is valid for 12 months.

    3.9 Refusal of blood productsÌý

    If the patient, parent/legal guardian indicated that they are not willing to provide consent for transfusions of blood products, please refer to theÌýÌý

    Please document all aspects related to refusal within the patient's medical record.ÌýÌý

    3.10 Key aligned documents / resourcesÌý

    • Australian Red Cross Lifeblood -Ìý
    • Department of Health - Bloods Matters consumer information -Ìý
    • South Australia blood transfusion fact sheets in 18 translations -Ìý
    ÌýDocument authorship and review detailsÌýÌý Ìý
    ÌýAuthorship Dr Gemma Crighton, Dr Helen Savoia, Anne KinmonthÌý
    ÌýDate first introducedÌý Ìý-Ìý
    ÌýDate of last reviewÌý Ìý24/03/2026
    ÌýDate of next review Ìý24/09/2027Ìý
    ÌýDetails of changes ÌýNew document as of 24/09/2024