p-OpTTICCA
Research type
Research Study
Full title
Optimizing Transfusion Thresholds in Critically-ill Children with Anaemia (p-OpTTICCA): A pilot trial for a large pragmatic international parallel open-label non-inferiority randomised controlled trial
IRAS ID
259635
Contact name
Avishay Sarfatti
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 27 days
Research summary
This is a small pilot feasibility study, ahead of a larger planned randomised trial comparing clinical outcomes aimed at comparing two different transfusion strategies in critically ill children.
Critically-ill children admitted to paediatric intensive care units (PICU) are often found to have anaemia, i.e. low levels of haemoglobin, the part of blood that carries oxygen around to the tissues in the body. This is particularly important because one of the hallmarks of critical illness is poor oxygen delivery to the tissues. Theoretically, we can improve by increasing haemoglobin levels through blood transfusion. The only randomised clinical trial in PICU compared two different haemoglobin based blood transfusion thresholds (TRIPICU). There was no significant difference in the PICU outcomes in both groups. However, close to 90% of potential participants (children with Hb ≤95 g/L) were not enrolled in TRIPICU due to a large number of exclusion criteria, clinician buy-in, and consent process. It is possible that the more restrictive strategy of transfusing children once the haemoglobin level is <70g/L may benefit all children but may also not be ideal in all circumstances.
In order to test this, we propose to conduct a trial comparing transfusion at a haemoglobin threshold of 70g/L versus usual care, in children, regardless of their clinical state, in PICU.
Prior to starting a randomised clinical trial, we would like to undertake this pilot trial to assess feasibility and acceptability to users of the study design. Children admitted to PICU will be randomised between two red cell transfusion strategies.
This pilot-RCT will focus on feasibility outcomes. It will explore whether we can 1) recruit a much broader eligible patient group, 2) assess protocol adherence, 3) assess the primary outcome measure, and 4) abstract most data electronically.REC name
London - City & East Research Ethics Committee
REC reference
21/LO/0274
Date of REC Opinion
10 May 2021
REC opinion
Further Information Favourable Opinion