Effect of Transfusion of Washed Reed Blood Cells on Neonatal Outcome: A Pilot Randomised Controlled Trial

Not Applicable

Completed

• Conditions: neonatal morbidity and mortality; Bronchopulmonary dysplasia; Retinopathy of prematurity; Necrotising enterocolitis; Peri/ Intraventricular haemorrhage; Nosocomial infection; Inflammatory and Immune System - Other inflammatory or immune system disorders; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12613000237785
• Lead Sponsor: Robinson Institute

Brief Summary

A growing body of observational data has recognised that transfusion exposure results in adverse responses and increased rates of morbidity in the recipient. The current study suggests that the association between transfusion and poor outcome may have a predominantly immunomodulatory basis, a relationship that may be altered by the use of washed packed red blood cells for the extremely preterm infant. Transfusion with washed packed red blood cells resulted in significant post-transfusion decreases in plasma pro-inflammatory cytokines and chemokines, while transfusion with unwashed packed red blood cells resulted in the opposite, with significant increases in IL-17A and TNF. Further, by the 3rd transfusion exposure, this response to unwashed blood was also associated with increases in markers of endothelial activation, an effect not seen with washed s. These alterations in pro-inflammatory cytokines and markers of endothelial activation in response to early, repeated transfusion exposure comparing the response to unwashed and washed packed red blood cells are novel. While the mechanisms underlying transfusion associated morbidities and immunomodulation are not yet fully understood, the current results provide strong mechanistic data supporting a potentially beneficial effect of transfusion of washed packed red blood cells in this high-risk population.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-27
• Study Completion: 2020-01-06
• Last Update Posted: 8 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 223

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified