ABC - A Post Intensive Care Anaemia Management Trial

NCT04591574 | Active Not Recruiting DMC

• 1 other identifier: AC19089
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Physical Disability; Quality of Life; Anemia Acute; Fatigue

Keywords

Post Intensive Care Recovery; Blood Transfusion; Physical Function; Moderate-Severe Anaemia; Systemic Inflammation; Impaired Erythrogenesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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

Study Arms (2)

Intervention Group

OTHER

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)

Usual care group

ACTIVE COMPARATOR

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)

Interventions

Red Blood Cells (Transfusion) BIOLOGICAL

Participants will receive RBC transfusions in accordance with trial protocol (intervention group) or usual care, which is in accordance with the NICE guidelines

Intervention Group; Usual care group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• University of Oxford: collaborator

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

Location

Related Publications (2)

• 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;27(1):98-106. doi: 10.1177/17511437251374884. eCollection 2026 Feb.

  PMID: 41244217 DERIVED

• 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.

  PMID: 38780066 DERIVED

MeSH Terms

Conditions

Fatigue

Interventions

Erythrocyte Count; Blood Transfusion

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: October 19, 2020
• Study Start: September 1, 2020
• Primary Completion: June 16, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

GB (1)