RecruitingACTRN12620000530921

Does washing blood for transfusion make a difference to preterm babies?

Transfusion with washed versus unwashed red blood cells to reduce morbidity and mortality in infants born less than 28 weeks gestation: a multi-centre, blinded, parallel group, randomised controlled trial. The WashT trial.

Sponsor

South Australian Health and Medical Reseach Institute

Enrollment

1,214 participants

Start Date

Mar 1, 2021

Study Type

Interventional

Conditions

Necrotizing Enterocolitis Retinopathy of Prematurity Intraventricular Haemorrhage Neonatal Mortality

Summary

Standard red blood cell transfusion is almost unavoidable in very preterm newborns. This common therapy likely causes harm by inciting an inflammatory response in the recipient, a precursor to injury and end organ morbidity. This inflammatory signal can be ameliorated with use of washed red blood cells. Though currently available from Red Cross this washed product incurs additional manufacturing costs and has a shorter half-life. Our randomised controlled trial will determine if washed, allogeneic red cells reduces end organ morbidity in surviving, very preterm newborns resulting in life-long benefit and thereby defraying the additional costs of product manufacture.

Eligibility

Sex: Both males and femalesMin Age: 23 WeekssMax Age: 28 Weekss

Plain Language Summary

Simplified for easier understanding

Very premature babies — those born before 28 weeks of pregnancy — almost always need blood transfusions because their bodies cannot yet produce enough red blood cells on their own. However, standard transfused blood can trigger inflammation in the baby's tiny body, which may contribute to serious complications such as injury to the bowel, lungs, and brain that can have lifelong effects. This trial is testing whether 'washing' the donated red blood cells before transfusion (to remove storage by-products) reduces this inflammatory response and leads to better health outcomes for these very premature babies. Washed blood is already available from the Red Cross Blood Service, though it costs more and has a shorter shelf life. Your baby may be eligible if they were born before 28 weeks of gestation and require one or more red blood cell transfusions. Babies who have already received a transfusion, received a fetal transfusion before birth, or have major congenital abnormalities are not eligible for this trial.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Group O Rhesus negative, washed leukodepleted red blood cells will be provided by Australian Red Cross Lifeblood. Washing of red blood cells will occur as per current established protocols. The wash

Group O Rhesus negative, washed leukodepleted red blood cells will be provided by Australian Red Cross Lifeblood. Washing of red blood cells will occur as per current established protocols. The washed leukodepleted red blood cells will be divided into four packs (quad-packs) using closed techniques. Washed leukodepleted red blood cell quad-packs will be supplied to the participating centres on a weekly basis. Washed, leukodepleted red cells split into quad packs using this process have a mean volume of 65 ± 6 mL/unit, a mean haematocrit of 54.8 ± 3.48. Each infant will receive their allocated red blood cell pack type for the first red blood cell transfusion and any subsequent red blood cell transfusions to first discharge home. The approach to transfusion will be standardised within each study centre, using a pre-defined restrictive haemoglobin threshold used in the Transfusion of Prematures (TOP) study. The haemoglobin threshold will be derived from a capillary, arterial or venous blood haemoglobin concentration ([Hb]) and adjusted for whether or not the infant is receiving respiratory support (invasive ventilation via endotracheal tube (ETT), nasal continuous positive airway pressure (CPAP), nasal non-invasive ventilation, nasal high flow, or supplemental oxygen) and by postnatal age. The protocol does not dictate sampling mode or how often [Hb] will be determined; this will be conducted according to local policies/clinician discretion. All [Hb] values derived from a complete blood examination (CBE) will be recorded to determine compliance with the transfusion threshold algorithm. Transfusion will be indicated whenever the [Hb] equals or falls below the threshold value and requires an active decision to transfuse to be made as soon as possible (at least within six hours of [Hb] determination) after the attainment of a threshold value. A fixed transfusion volume of 15 mL/kg will be given. Weekly reviews of the database and on-site audits using medical and online records will be conducted at each site to determine adherence to the transfusion protocol. 1. Adherence to transfusion protocol – each screened infants’ [Hb] from a CBE and respiratory support requirements at time of [Hb] will be entered into REDcap by a research nurse, or nominee, on a daily basis for the first three weeks of life. Following this, weekly [Hb] results will be recorded. An in-built alert system will alert clinicians and study personnel if a transfusion event has been triggered. 2. Dispensing and product accountability – compliance with the randomised intervention will be managed by the transfusion laboratory with each study participant and allocated product identified electronically through REDCap. This process will be audited routinely to ensure individual units and transfusions laboratories are maintaining randomisation compliance. This information will be communicated, blinded, to the Trial Management Committee.