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Do donor white blood cells survive in children who need a blood transfusion?

Is there an incidence of donor white blood cell survival (microchimerism) in paediatric transfusion recipients?

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616001066471
Enrollment
44
Registered
2016-08-09
Start date
2016-12-05
Completion date
2020-12-31
Last updated
2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Some adverse transfusion-related reactions are hypothesised to be primarily mediated by donor white blood cells (leucocytes) present in red blood cell (RBC) units. Leucodepletion (removal of leucocytes via filtration) has successfully reduced transfusion related reactions, however current clinical data suggests that RBC transfusion can still result in poor patient outcomes. One such undesirable outcome is the development of microchimerism, where genetically distinct donor leucocytes are detected within a transfused patient. Transfusion-associated microchimerism has primarily been reported in trauma patients who receive multiple blood units and often have an underlying disruption of their immune response. In Australia, we reported that despite the use of leucodepleted blood components 10% of trauma patients showed an incidence of microchimerism. However, it is still unknown whether there is an incidence of microchimerism in other Australian transfusion recipients. This study aims to gather preliminary data on the incidence of microchimerism in chronically transfused paediatric patients. These patients were chosen since they receive multiple RBC units and may be immunosuppressed at the time of transfusion. It is currently unknown whether chronic red blood cell treatment results in long term donor white cell survival (microchimerism) within this patient group and whether the use of gamma-irradiated blood components can affect any potential incidence found. To test for the presence of surviving donor cells in chronically transfused paediatric cases both a retrospective (look-back) and prospective (current) study will be collected. For the retrospective study, a single blood samples (1mL) will be analysed for an incidence of microchimerism. These patients will have been transfused 5-15 years ago and will enable data to be gathered on whether there is a long-term donor cell survival. For the prospective study, a blood sample (1mL) will be collected before transfusion, routinely before each red blood cell unit transfusion during the course of their treatment and at 12-18 months following treatment completion. Genomic DNA will be isolated from the blood sample which will undergo a sensitive genetic test for a series of insertion/deletion sequences which are diagnostic for the presence of microchimerism.

Interventions

This study is a pilot observational study only. A blood sample (1mL, 0.2 teaspoon) will be taken from any paediatric patients with any indication who requires a routine blood transfusion with at least one paediatric sized red blood cell unit as standard of care treatment. Since some patients will require multiple transfusions over the course of their treatment. The research samples will be taken before transfusion and during other routine standard of care samples that will be taken, this can m

This study is a pilot observational study only. A blood sample (1mL, 0.2 teaspoon) will be taken from any paediatric patients with any indication who requires a routine blood transfusion with at least one paediatric sized red blood cell unit as standard of care treatment. Since some patients will require multiple transfusions over the course of their treatment. The research samples will be taken before transfusion and during other routine standard of care samples that will be taken, this can mean samples will be taken every week or every few months depending on the clinical diagnosis of the patient. It is expected that each patient may provided up to, but not limited to, 10 samples over the 18 month study period and up to 12 months post transfusion.

Sponsors

Australian Red Cross Blood Service
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
No minimum to 16 Years
Healthy volunteers
No

Inclusion criteria

For retrospective study Male and female paediatric patients between the age of 0-16 years of age admitted for (but not limited to) haematology or oncology conditions which require chronic blood transfusion as part of treatment and who have received at least one blood transfusion between 5-15 years prior to enrollment into this study. For prospective study Male and female paediatric patients between the age of 0-16 years of age admitted for (but not limited to) haematology or oncology conditions which require chronic blood transfusion as part of treatment.

Exclusion criteria

For both retrospective and prospective studies these exclusion criteria apply: 1)No blood transfusion given 2) Females who are pregnant, or have previously been pregnant 3) Mentally impaired or individuals in dependant relationships who are not sound of mind to consent to agree to participate in this study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026