ABC - A Post Intensive Care Anaemia Management Trial

NCT ID: NCT04591574

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2026-05-31

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

Anemia Acute; Fatigue; Physical Disability; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Red Blood Cells (Transfusion)

Intervention Type: BIOLOGICAL

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

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

Group Type: ACTIVE_COMPARATOR

Red Blood Cells (Transfusion)

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Edinburgh

OTHER

Sponsor Role: lead

University of Oxford

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Locations

NHS Lothian

Edinburgh, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 41244217 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38780066 (View on PubMed)

Other Identifiers

AC19089

Identifier Type: -

Identifier Source: org_study_id