What are Blood Products
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A blood product is any therapeutic substance derived from human blood, including whole blood and other blood components for transfusion, and plasma-derived medicinal products (PDMPs).
Medicinal (medical therapeutic) products derived from human donations of blood and plasma play a critical role in health care. Safe, effective and quality-assured blood products contribute to improving and saving millions of lives every year, as they:
- address child mortality and maternal health;
- dramatically improve the life expectancy and quality of life of patients suffering from life-threatening inherited disorders, such as haemophilia, thalassaemia and immune deficiency, and acquired conditions such as cancer and traumatic haemorrhage; and
- support complex medical and surgical procedures, including transplantation.
An insufficient or unsafe blood supply for transfusion has a negative impact on the effectiveness of key health services and programmes to provide appropriate patient care in numerous acute and chronic conditions. Ensuring access of all patients who require transfusion to safe, effective and quality-assured blood products is a key component of an effective health system and vital for patient safety.
Impact
Blood products contribute to the saving of millions of lives every year, improve dramatically life expectancy and the quality of life of patients suffering from life-threatening conditions, and support complex medical and surgical procedures.
In high-income countries, blood products are most commonly used to support advanced medical and surgical procedures, including treatments of cancer and haematological diseases, trauma resuscitation, cardiovascular surgery and transplantation. In lower-income countries where diagnosis and treatment options are limited, a greater portion of blood is used to treat women with obstetric emergencies and children suffering from severe anaemia, often resulting from malaria and malnutrition.
In many countries, demand outstrips supply, and blood services throughout the world face the daunting challenge of making sufficient supplies of blood products available, while also ensuring the quality and safety of these products in the face of known and emerging threats to public health.
Red Cells
They may be resuspended in other additives to prolong storage and filtered to remove most of the leucocytes.
A red cell unit is divided into four packs of equal volume to create paediatric red cells. This is to reduce donor exposure for small volume paediatric transfusions and to minimise product wastage.
Washed red cells are prepared using a manual process that double washes leucodepleted red cells (<14 days old) with SAG-M (saline adenine mannitol glucose) solution to remove the majority of plasma proteins, antibodies and electrolytes. The washed red cells are then resuspended in SAG-M solution to preserve their shelf life.
Red cells must be stored at 2 to 6ºC and have a variable shelf life.
Typical unit content and specifications
The typical unit content data is derived from Lifeblood process control testing. For each parameter, the mean value (± 1 SD) and specification is shown.
Data is for the period 1 January to 31 December 2023.
Red cells leucocyte depleted
| Volume (mL) | 258± 15 (>220) |
| Haemoglobin (g/unit) | 49 ± 5 (≥ 40) |
| Haematocrit (L/L) | 0.60± 0.03 (0.50–0.70) |
| Haemolysis (% at expiry) | 0.3 ± 0.1 (< 0.8) |
| Leucocyte count (106 /unit) | 0.03± 0.09(< 1.0) |
Paediatric red cells leucocyte depleted
| Volume (mL) | 60 ± 4 (25–100) |
| Haemoglobin (g/unit) | (Initial unit prior to splitting ≥ 40) |
| Haematocrit (L/L) | 0.62± 0.03(0.50–0.70) |
| Haemolysis (% at expiry) | 0.2 ± 0.1 (< 0.8) |
| Leucocyte count (106 /unit) | (Initial unit prior to splitting < 1.0) |
Washed red cells leucocyte depleted
| Volume (mL) | 264± 16(> 130) |
| Haemoglobin (g/unit) | 50 ± 5 (≥ 40) |
| Haematocrit (L/L) | 0.62 ± 0.03 (0.50–0.70) |
| Haemolysis (% at expiry) | 0.2 ± 0.1 (< 0.8) |
| Leucocyte count (10^6 /unit) | (Initial unit prior to splitting <1.0) |
| Last wash supernatant total protein (g/unit) | 0.01 ± 0.00 (< 0.5) |
Availability
Leucodepleted red cells are available in Group O, A, B and AB, and RhD positive and RhD negative groups.
Platelets
For apheresis platelets, an apheresis machine separates anticoagulated blood into components and retains platelets and a portion of plasma, which are resuspended in a bag containing platelet additive solution (PAS). The remaining elements (red and white blood cells) and the majority of the plasma are either returned to the donor or collected for preparation of other component types.
One, two or three adult doses of platelets may be prepared from a single apheresis platelet donation. If required, one adult apheresis platelet dose can be divided into three units to produce paediatric apheresis platelets. This reduces donor exposure for paediatric recipients and minimises product wastage.
Whole blood derived platelets are produced by harvesting platelets from a pool of buffy coats from four ABO and RhD identical whole blood donations. The platelets are resuspended in platelet additive solution to produce the pooled platelet component.
Both apheresis and pooled platelets are leucodepleted during or soon after collection and are also irradiated before release from Lifeblood.
Platelets can be stored for 7 days after collection at 20 - 24º C with gentle agitation.
Platelets can be irradiated at any stage during their 7-day storage and thereafter can be stored up to their normal shelf life of 7 days after collection.
Typical unit content and specifications
The typical unit content data is derived from Lifeblood process control testing. For each parameter, the mean value (± 1 SD) and specification is shown.
Unless otherwise specified, data is for the period 1 January to 31 December 2023.
Platelet apheresis leucocyte depleted in platelet additive solution (PAS)
| Volume (mL) | 212 ± 10(100–400) |
| Platelet count (109/unit) | 281± 36(> 200 to ≤ 450) |
| pH | 7.1 ± 0.1 (6.4-7.4) |
| Leucocyte count (106 /unit) | 0.2 ± 0.1 (< 1.0) |
| Residual plasma content (%) | Approximately 40% |
Platelets paediatric apheresis leucocyte depleted
| Volume (mL) | 55 ± 1 (40-60) |
| Platelet count (109/unit) | 72± 10(> 50) |
| pH | 7.1 ± 0.1 (6.4-7.4) |
| Leucocyte count (106 /unit) | (Initial unit prior to splitting < 1.0) |
| Residual plasma content (%) | Approximately 40% |
Platelets pooled leucocyte depleted
| Volume (mL) | 273 ± 11(> 160) |
| Platelet count (109 /unit) | 266± 38(> 200) |
| pH | 7.0± 0.1(6.4-7.4) |
| Leucocyte count (106 /unit) | 0.03 ± 0.15 (< 1.0) |
| Residual plasma content (%) | Approximately 30% |
Availability
Platelets are available in all ABO groups and RhD positive and negative groups. Group AB is manufactured on request.
Fresh Frozen Plasma (FFP)
The freezing process must commence within 18 hours of collection for whole blood plasma and within 6 hours of collection for apheresis plasma.
FFP must be frozen to a core temperature below –30º C within 1 hour of starting the freezing process.
A unit of FFP contains all coagulation factors including the labile plasma coagulation Factors VIII and V. An adult dose contains approximately 200 IU of Factor VIII.
FFP has a shelf life of 12 months when stored at –25º C or below.
Paediatric FFP is produced from a single adult unit of whole blood plasma which is then separated into four packs of equal volume. This reduces donor exposure for small volume paediatric transfusions and minimises product wastage.
Typical unit content and specifications
The typical unit content data is derived from Lifeblood process control testing. For each parameter, the mean value (± 1 SD) and specification is shown.
Unless otherwise specified, data is for the period 1 January to 31 December 2023.
Fresh frozen plasma whole blood
| Volume (mL) | 285± 14(250–310) |
| Factor VIIIc (IU/mL) | 1.11± 0.37 (≥ 0.70) |
Fresh frozen plasma paediatric
| Volume (mL) | 69± 4 (60–80) |
Fresh frozen plasma apheresis
| Volume (mL) | 272± 5(250–310) |
| Factor VIIIc (IU/mL) | 1.38 ± 0.41(≥ 0.70) |
Availability
This component is available in all ABO groups. Matching for RhD type is not necessary.
Cryodepleted Plasma
It contains most clotting factors in similar amounts to FFP but is deficient in factor VIII, fibrinogen, von Willebrand factor (the high molecular weight multimers are more thoroughly removed than the smaller multimers), factor XIII and fibronectin.
Cryodepleted plasma has a shelf life of 12 months when stored at –25˚ C or below.
Typical unit content and specifications
The typical unit content data is derived from Lifeblood process control testing. For each parameter, the mean value (± 1 SD) and specification is shown.
Unless otherwise specified, data is for the period 1 January to 31 December 2023.
Cryodepleted plasma whole blood
| Volume (mL) | 247± 13 (215–265) |
Cryodepleted plasma apheresis
| Volume (mL) | 757±10 (675–825) |
Availability
Cryodepleted plasma is available in all ABO groups. Matching for RhD type is not required.
Modifications
There is no modification available for cryodepleted plasma. Matching for RhD type is not required.
Cryoprecipitate
Cryoprecipitate is obtained from thawed frozen plasma and is used for patients with fibrinogen deficiency or dysfibrinogenaemia.
Cryoprecipitate is prepared from plasma derived from both whole blood and apheresis donations. Fresh frozen plasma (FFP) is slowly thawed at a temperature between 1–6 ˚C and the resulting cold-insoluble precipitate is removed and then refrozen.
Cryoprecipitate contains most of the factor VIII, fibrinogen, factor XIII, von Willebrand factor and fibronectin found in FFP.
Cryoprecipitate has a shelf life of 12 months when stored at –25º C or below.
One unit of apheresis cryoprecipitate is approximately equivalent to 2.5 units of whole blood-derived cryoprecipitate.
When reviewing international studies of fibrinogen replacement, ensure that the current fibrinogen content in Australian cryoprecipitate is considered when estimating equivalence. Due to differences in manufacturing process between Blood Services internationally, fibrinogen content per 'unit' (pack) and per mL can vary considerably.
Typical unit content and specifications
The typical unit content data is derived from Lifeblood process control testing. For each parameter, the mean value (± 1 SD) and specification is shown.
Unless otherwise specified, data is for the period 1 January to 31 December 2023.
Cryoprecipitate whole blood
| Volume (mL) | 37 ± 2 (30–40) |
| Factor VIIIc (IU/unit) | 152± 40(≥ 70) |
| Fibrinogen (mg/unit) | 372± 114(≥ 140) |
| Von Willebrand factor (IU/unit) | 249± 56(> 100) |
Cryoprecipitate apheresis
| Volume (mL) | 60 ± 2 (54–66) |
| Factor VIIIc (IU/unit) | 396 ± 71(≥ 70) |
| Fibrinogen (mg/unit) | 1079 ± 299(≥ 140) |
| Von Willebrand factor (IU/unit) | 666 ± 125(> 100) |
Availability
Cryoprecipitate is available in all ABO groups. Matching for RhD group is not required.
Modifications
There are no modifications available for cryoprecipitate.