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Active, Not Recruiting

NCT Number: NCT04591574

ABC - A Post Intensive Care Anaemia Management 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Lothian

Edinburgh, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Patient Fatigue (Fatigue Severity Scale (FSS)) at 1, 3 and 6 months post randomisation

    Time frame: 6 months post randomisation

  3. 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

  4. Activities of Daily Living (ADLs) (from WHODAS questionnaire) at 3 months post randomisation

    Time frame: 3 months post randomisation

  5. Patients alive at 1, 3, and 6 months post-randomisation

    Time frame: 6 months post randomisation

  6. Patients alive at 5 years post-randomisation derived from data linkage

    Time frame: 5 years post randomisation

  7. Haemoglobin concentration at 1 month post-randomisation

    Time frame: 1 month post randomisation

  8. Post-ICU length of hospital stay

    Time frame: Variable according to patient's length of hospital stay

  9. Care costs during 6 months post-randomisation

    Time frame: 6 months post randomisation

  10. Incremental cost per QALY at 6 months

    Time frame: 6 months post randomisation

  11. Care costs derived from data linkage during 5 years post-randomisation

    Time frame: 5 years post randomisation

  12. Protocol compliance (during intervention index hospital stay)

    Time frame: Throughout the study, for an average of 1 month

    Proportion of participants compliant with the study intervention as per protocol (%).

  13. Hb concentration (during index hospital stay)

    Time frame: Throughout the study, for an average of 1 month

  14. RBC use (during 3 months follow up)

    Time frame: 3 months post randomisation

  15. New Infections (during 3 months follow-up)

    Time frame: 3 months post randomisation

  16. Transfusion-related adverse events (during 3 months follow-up)

    Time frame: 3 months post randomisation

  17. Major adverse cardiovascular events (MACE; during 3 months follow-up)

    Time frame: 3 months post randomisation

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • University of Oxford

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Oct 19, 2020
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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