NCT04591574

ABC - A Post Intensive Care Anaemia Management Trial

Active, enrolled NA Last updated 9 January 2026

What this trial tests

NA trial testing Red Blood Cells (Transfusion) in Anemia Acute in 346 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 September 2020

Primary endpoint
16 June 2025

31 May 2026

Quick facts

Lead sponsor	University of Edinburgh
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	346
Start date	1 September 2020
Primary completion	16 June 2025
Estimated completion	31 May 2026
Sites	1 location across United Kingdom

Drugs / interventions tested

• Red Blood Cells (Transfusion) — full drug profile →

Conditions studied

• Anemia Acute — all drugs for Anemia Acute →
• Fatigue — all drugs for Fatigue →
• Physical Disability — all drugs for Physical Disability →
• Quality of Life — all drugs for Quality of Life →

Sponsor

University of Edinburgh

Who can join

16 and older, any sex, with Anemia Acute or Fatigue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transfusion thresholds for guiding red blood cell transfusion.
   Carson JL, Stanworth SJ, Dennis JA, Trivella M, et al · · 2021 · cited 165× · PMID 34932836 · DOI 10.1002/14651858.cd002042.pub5
2. 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.
   Radford M, Estcourt LJ, Sirotich E, Pitre T, et al · · 2024 · cited 8× · PMID 38780066 · DOI 10.1002/14651858.cd011305.pub3
3. Anaemia management with red blood cell transfusion to improve post-intensive care disability: Protocol for the ABC post-ICU randomised controlled trial.
   Walsh TS, Emerson L, Singleton J, Locherty R, et al · · 2026 · PMID 41244217 · DOI 10.1177/17511437251374884