On discharge from intensive care (ICU) patients are often severely anaemic (have a low level of haemoglobin (Hb) in their red blood cells (RBC)). Anaemia can persist for many months making patients feel tired and fatigued. Regaining pre-illness health and energy levels can take a long time. The ABC Post Intensive Care Trial will be the first trial to investigate if an anaemic ICU patient's health can be improved by treating with RBC transfusions following ICU discharge. We will compare the current approach as per national guidelines (restrictive transfusion), with a more active transfusion regime to correct anaemia from ICU discharge to hospital discharge. The trial will take place in acute hospitals throughout the UK where patients are discharged after a period of time in ICU. Patients discharged, or ready for discharge from ICU will be approached to consider participation in the trial. Once Hb level drops below 94g/L they would become eligible for inclusion (subject to meeting inclusion/exclusion criteria). The main indication for being excluded from participating in the trial is that transfusions are contraindicated (not appropriate for the patient) or they have an objection to blood transfusions. Group allocation will be randomly assigned at ICU discharge. We will explore which patients benefit most from transfusions and those who gain no benefit. Patients will have their Hb level checked at least weekly whilst in hospital and based on the result will have RBC transfusions as required according to the treatment regime they were randomised to. Part of the research is based on self-reported quality of life so participants will be asked to complete a number of questionnaires at set time-points from randomisation to 6 months post randomisation. Each participant will be actively on trial for approximately 6 months. The five-year follow will be done using routinely collected data from national databases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
346
Participants will receive RBC transfusions in accordance with trial protocol (intervention group) or usual care, which is in accordance with the NICE guidelines
NHS Lothian
Edinburgh, United Kingdom
Physical component score (PCS) of the SF-36 Health Related Quality of Life (HRQoL) questionnaire at 3 months post randomisation
Time frame: 3 months post randomisation
PCS of the SF-36 HRQoL questionnaire (and its four sub-domains) at 1 and 6 months post randomisation.
Time frame: 6 months post randomisation
Patient Fatigue (Fatigue Severity Scale (FSS)) at 1, 3 and 6 months post randomisation
Time frame: 6 months post randomisation
Mental Component Score of SF-36 (and its four sub-domains) at 1, 3 and 6 months post randomisation
Time frame: 6 months post randomisation
Activities of Daily Living (ADLs) (from WHODAS questionnaire) at 3 months post randomisation
Time frame: 3 months post randomisation
Patients alive at 1, 3, and 6 months post-randomisation
Time frame: 6 months post randomisation
Patients alive at 5 years post-randomisation derived from data linkage
Time frame: 5 years post randomisation
Haemoglobin concentration at 1 month post-randomisation
Time frame: 1 month post randomisation
Post-ICU length of hospital stay
Time frame: Variable according to patient's length of hospital stay
Care costs during 6 months post-randomisation
Time frame: 6 months post randomisation
Incremental cost per QALY at 6 months
Time frame: 6 months post randomisation
Care costs derived from data linkage during 5 years post-randomisation
Time frame: 5 years post randomisation
Protocol compliance (during intervention index hospital stay)
Proportion of participants compliant with the study intervention as per protocol (%).
Time frame: Throughout the study, for an average of 1 month
Hb concentration (during index hospital stay)
Time frame: Throughout the study, for an average of 1 month
RBC use (during 3 months follow up)
Time frame: 3 months post randomisation
New Infections (during 3 months follow-up)
Time frame: 3 months post randomisation
Transfusion-related adverse events (during 3 months follow-up)
Time frame: 3 months post randomisation
Major adverse cardiovascular events (MACE; during 3 months follow-up)
Time frame: 3 months post randomisation
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