Informed consent for blood product transfusions
1. Purpose and scope
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 Blood
Products Procedure and the Consent – Informed Procedure.
Patient consent to blood product form MR 634/A (RCH use only).
2. Definitions
Term / Abbreviation | Red cells, platelets, fresh frozen plasma, cryoprecipitate |
FFP | Fresh frozen plasma |
HBV | Hepatitis B virus |
HCV | Hepatitis C virus |
HIV | Human immunodeficiency virus |
IVIg | Intravenous Immunoglobulin |
Plasma-derived blood components (batched) | Albumin, IVIg, Beriplex, Biostate, Riastap (Fibrinogen concentrate) |
SCIg | Subcutaneous immunoglobulin |
3. Guideline
3.1 Consent discussion
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.
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 transfusion
- The duration of the consent.
3.2 Types of blood products and benefits
Type of blood product (fresh) | Possible benefits and / or indication |
Red cells | Relieve symptoms of anaemia (fatigue, lethargy) Increase
oxygen carrying capacity to organs and tissues |
Platelets | May prevent or treat bleeding |
FFP |
Cryoprecipitate |
Granulocytes | May help treat infection |
Type of blood product (batched) | Possible benefits and / or indication |
Albumin 5% and 20% | Used to treat or prevent shock, treat hypovolaemia and
used to replace low albumin levels. |
SCIg | Used to replace low levels of immunoglobulins and prevent infection or used
as an immunomodulatory agent. |
Plasma derived clotting factors (e.g.,
Beriplex, Biostate, Riastap – fibrinogen concentrate) | Used to replace low clotting factor levels |
Antithrombin III | Used to replace low antithrombin levels and prevent thrombosis. |
Rh(D) immunoglobulin | Used to prevent RhD sensitisation in RhD negative patients during
pregnancy or following an RhD positive transfusion. |
Other immunoglobulins (e.g.,
CMV immunoglobulin, Hepatitis B immunoglobulin, Tetanus immunoglobulin, Zoster immunoglobulin,
Normal Human immunoglobulin) | May be used to prevent or treat infection in naïve patients following
potential infection-exposure. |
3.3 Risks associated with transfusion
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:
Type of complication | Adverse event | Approximate incidence |
Mild reaction | Fever | 0.1% to 1% |
Rash or urticaria (mild allergic) | 1 - 3 % |
Severe allergic reaction | Anaphylaxis | 1:20,000 - 1:50,000 |
Infection | Bacterial infection | 1:250,000 (platelets) 1:2.5 million (red cells) |
Viral infection | <1:1 million (HIV) <1:1 million (HBV) <1:1
million (HCV) |
Respiratory | Transfusion-associated circulatory overload (TACO) | 1% |
Transfusion related acute lung injury (TRALI) | 1:1,200 - 1:190,000 |
Haemolytic | Acute haemolytic reaction | 1:76,000 |
Delayed haemolytic reaction | 1:2,500 – 1:11,000 |
Antibody formation | 1% (red cell antigens) 10%
(HLA antigen) |
Iron overload | Requiring chelation | May occur after >20 red cell units |
For further information see Australian Red Cross
Lifeblood websites for more information https://www.lifeblood.com.au/health-professionals/clinical-practice/adverse-events/classification-incidence
3.4 Risks of not having a transfusion
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.
3.5 Possible alternatives to transfusion
Blood product | Possible alternative to transfusion |
Red cells | Iron therapy (oral/IV), haematinics (B12/folate), cell salvage
(surgery), erythropoietin- stimulating agents. |
Plasma | Factor concentrates if applicable or tranexamic acid |
Platelets | Tranexamic acid |
3.6 Patient and family information
Information on blood
product transfusion will be offered to the patient, parents/legal guardians.
Provision of
information must be documented on the MR634/A form.
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 has a dedicated paper-based consent form for
the documentation of transfusion consent. Patient
consent to blood products MR634/A.
A copy of the transfusion consent form should be kept at
the patient’s bedside until they are discharged. The original signed form
should be sent to HIS for scanning.
When the transfusion consent form has been scanned
into the EMR, or if a patient has a standing consent form (e.g. chronically
transfused patient valid for 12 months) it can be viewed in chart review section of EMR under the
Media tab.
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 MR634/A consent form must be completed with
the family prior to surgery.
The consent form should be sighted by medical and
nursing clinicians prior to the prescription and administration of blood
products.
3.8 Duration of blood transfusion consent
Blood product transfusion consent is valid for a
child’s entire admission, e.g., if the child requires multiple blood product
transfusion during their admission only one blood product transfusion consent
form is required.
When a child needs ongoing transfusion support (e.g.
oncology patient, transfusion dependent patient, patient receiving immunoglobulin
replacement therapy), consent can be sought for 12 months. The consent form will
indicate an expiry date of the long-term consent.
3.9 Refusal of blood products
If the patient, parent/legal guardian indicated that
they are not willing to provide consent for transfusions of blood products,
please refer to the Blood
Refusal – Management of Procedure
Please document in both the medical record and on the
blood transfusion consent form.
3.10 Key aligned documents / resources
Document authorship and review details | |
Authorship | Dr Gemma Crighton, Dr Helen Savoia, Anne Kinmonth |
Date first introduced | - |
Date of last review | 7/01/2025 |
Date of next review | 24/09/2027 |
Details of changes | New document as of 24/09/2024 |