ABC - A Post Intensive Care Anaemia Management Trial

Anaemia Management With Red Blood Cell Transfusion to Improve Post-intensive Care Disability: a Randomised Controlled Trial (The ABC Post-intensive Care Trial)

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 Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Fatigue; Physical Disability; Anemia Acute
• Intervention / Treatment: Biological: Red Blood Cells (Transfusion)

• Study Type: Interventional
• Enrollment (Actual): 346
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • Nhs Lothian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient who received level 3 ICU care at any time point during the current hospital admission (defined as advance respiratory support and/or at least two organ support).
• Patient considered ready for discharge from ICU by the caring clinical team.
• Hb less than or equal to 94g/L when ready for ICU discharge or during the first seven days following the decision by the treating clinician that the patient is ready for ICU discharge.
• 16years of age or older
• Patient expected to remain in study hospital until hospital discharge.
• Consent provided (by participant or in accordance with appropriate mental capacity legislation for the site).

Exclusion Criteria:

• Contraindication or objection to RBC transfusion
• Active bleeding when screened
• Primary neurological ICU admission diagnosis
• Patients discharged from the ICU following cardiac surgery
• Currently receiving or planned to receive end-of-life care
• Not expected by clinical team to survive to hospital discharge
• Patient with a proven chronic haematological disease that requires regular RBC transfusion to treat anaemia
• Patient with dialysis-dependent chronic renal failure prior to ICU admission
• Patient receiving regular erythropoietin (or any erythropoiesis stimulating agent) treatment for anaemia prior to ICU admission
• Unable to obtain consent (frompatietn or in accordance with appropriate mental capacity legislation for the site)
• Readmission to ICU during current hospitalisation episode and not enrolled following previous ICU admissions
• Patient recovering following liver transplantation, kidney transplantation, or combined kidney/pancreas transplantation
• Patient recovering from variceal bleeding due to chronic liver disease
• Prisoners
• Patient due for imminent hospital discharge within the next 24 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention Group; All patients will receive a single unit red blood cell (RBC) transfusion post randomisation. Single RBC transfusions will subsequently be administered to achieve and maintain haemoglobin (Hb) concentration of 100-120g/L unitl hospital discharge. Hb measured at least weekly in hospital.	Biological: Red Blood Cells (Transfusion); Participants will receive RBC transfusions in accordance with trial protocol (intervention group) or usual care, which is in accordance with the NICE guidelines
Active Comparator: Usual care group; Current usual care transfusion practice, namely single RBC transfusions when Hb 70g/L or less (or modified according to clinician decision) to achieve target Hb 70-90g/L. HB measured at least weekly in hospital	Biological: Red Blood Cells (Transfusion); Participants will receive RBC transfusions in accordance with trial protocol (intervention group) or usual care, which is in accordance with the NICE guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical component score (PCS) of the SF-36 Health Related Quality of Life (HRQoL) questionnaire at 3 months post randomisation	3 months post randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCS of the SF-36 HRQoL questionnaire (and its four sub-domains) at 1 and 6 months post randomisation.		6 months post randomisation
Patient Fatigue (Fatigue Severity Scale (FSS)) at 1, 3 and 6 months post randomisation		6 months post randomisation
Mental Component Score of SF-36 (and its four sub-domains) at 1, 3 and 6 months post randomisation		6 months post randomisation
Activities of Daily Living (ADLs) (from WHODAS questionnaire) at 3 months post randomisation		3 months post randomisation
Patients alive at 1, 3, and 6 months post-randomisation		6 months post randomisation
Patients alive at 5 years post-randomisation derived from data linkage		5 years post randomisation
Haemoglobin concentration at 1 month post-randomisation		1 month post randomisation
Post-ICU length of hospital stay		Variable according to patient's length of hospital stay
Care costs during 6 months post-randomisation		6 months post randomisation
Incremental cost per QALY at 6 months		6 months post randomisation
Care costs derived from data linkage during 5 years post-randomisation		5 years post randomisation
Protocol compliance (during intervention index hospital stay)	Proportion of participants compliant with the study intervention as per protocol (%).	Throughout the study, for an average of 1 month
Hb concentration (during index hospital stay)		Throughout the study, for an average of 1 month
RBC use (during 3 months follow up)		3 months post randomisation
New Infections (during 3 months follow-up)		3 months post randomisation
Transfusion-related adverse events (during 3 months follow-up)		3 months post randomisation
Major adverse cardiovascular events (MACE; during 3 months follow-up)		3 months post randomisation

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: University of Oxford

Publications and helpful links

General Publications

• Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
• Walsh TS, Emerson L, Singleton J, Locherty R, Hope D, Cholbi S, Giddings A, Macdonald A, Lone N, Docherty AB, Mead G, Stanworth SJ, Drakesmith A, Roy NBA, Hall P, Neilson AR, Pollock R, Rodriguez A, Norrie J, Weir CJ, Shah A, Griffith D. Anaemia management with red blood cell transfusion to improve post-intensive care disability: Protocol for the ABC post-ICU randomised controlled trial. J Intensive Care Soc. 2025 Nov 12:17511437251374884. doi: 10.1177/17511437251374884. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): June 16, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Blood Transfusion; Physical Function; Post Intensive Care Recovery; Moderate-Severe Anaemia; Systemic Inflammation; Impaired Erythrogenesis
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fatigue; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cell Count; Cytological Techniques; Hematologic Tests; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Biological Therapy; Blood Cell Count; Blood Transfusion; Erythrocyte Count
• Other Study ID Numbers: AC19089

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No