None listed
Conditions
Brief summary
Extremely low gestational age newborns represent the smallest and most immature newborns and are at greatest risk of dying or surviving with significant morbidity particularly neurodevelopmental disability. Over 90% of these newborns receive at least one packed red blood cell (PRBC) transfusion whilst in neonatal intensive care with the majority receiving between 3 and 5 transfusions during their primary hospital admission. There is increasing evidence that PRBC transfusions are independently associated with more frequent and severe cardiopulmonary, gastrointestinal and neurodevelopmental morbidities. Indeed, in comparison to other populations, these transfusion associated adverse events are more common in the preterm newborn. Packed red blood cells are biologically active. We have shown that PRBC transfusion results in endothelial activation, inflammation and oxidative stress in preterm neonates. This transfusion related immunomodulation (TRIM) might contribute to the recognised association between allogeneic PRBC transfusion and adverse clinical outcomes. It is unclear if TRIM is a response to red blood cells themselves, the time-dependent accumulation of bioactive substances in the supernatant (storage lesion), or both. However, in adult and childhood populations significant benefit is gained from modifications in blood product processing such as PRBC washing, though this has never been studied in the preterm neonate. Any reduction in PRBC transfusion related harm would be of substantial clinical benefit in this at risk population. This pragmatic clinical trial aims to identify if transfusion with washed PRBCs reduces harm from transfusion in high-risk newborns.
Interventions
Standard (red cell leukodeplete) packed red blood cells will be supplied from Australian Red Cross Blood Service to the study centres. Two 3-day old Group O Rh- cross-match compatible standard packed red blood cell packs will be washed at the Blood Service following standard methodology and subsequently divided into 4 paediatric packs using closed techniques. The prepared washed packed red blood cells, with a shelf life of 28 days will be supplied on a weekly basis for use in study subjects. Only washed packs aged less than 14 days will be allocated to enrolled subjects, controlling for red cell lesion, and residual unused packs will be discarded weekly. Infants randomised to this group will receive standard packed red blood cells washed pre-transfusion. Infants who require more than one transfusion will continue to receive washed packed red blood cells for any subsequent transfusion that is required. If an infant requires an emergency transfusion and no washed packed red blood cells are available for issue from blood bank, O-negative, cross-match compatible, unwashed packed red blood cells will be administered in accordance with current neonatal practice guidelines. Enrolled infants will receive either washed or standard packed red blood cell transfusion from 24 hours of age until discharge from their primary hospital admission.
Sponsors
Study design
Eligibility
Inclusion criteria
Infant’s born with a gestational age up to 28 weeks 6 days clinically requiring a packed red blood cell transfusion transfusion.
Exclusion criteria
Infants with major congenital or chromosomal abnormalities Infants who have received a packed red blood cell transfusion in the first 24 hours of life.