Anemia AcuteNCT04591574
ABC - A Post Intensive Care Anaemia Management Trial
A study testing Red Blood Cells (Transfusion) in people with Anemia Acute and Fatigue, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anemia Acute, Fatigue, Physical Disability
- What is being tested?
- Red Blood Cells (Transfusion)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2020to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Red Blood Cells (Transfusion)
- Keywords
- Post Intensive Care Recovery, Blood Transfusion, Physical Function, Moderate-Severe Anaemia, Systemic Inflammation, Impaired Erythrogenesis
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Biological: Red Blood Cells (Transfusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical component score (PCS) of the SF-36 Health Related Quality of Life (HRQoL) questionnaire at 3 months post randomisation
Measured: 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.
Measured: 6 months post randomisation
Patient Fatigue (Fatigue Severity Scale (FSS)) at 1, 3 and 6 months post randomisation
Measured: 6 months post randomisation
Mental Component Score of SF-36 (and its four sub-domains) at 1, 3 and 6 months post randomisation
Measured: 6 months post randomisation
Activities of Daily Living (ADLs) (from WHODAS questionnaire) at 3 months post randomisation
Measured: 3 months post randomisation
Patients alive at 1, 3, and 6 months post-randomisation
Measured: 6 months post randomisation
Patients alive at 5 years post-randomisation derived from data linkage
Measured: 5 years post randomisation
Haemoglobin concentration at 1 month post-randomisation
Measured: 1 month post randomisation
Post-ICU length of hospital stay
Measured: Variable according to patient's length of hospital stay
Care costs during 6 months post-randomisation
Measured: 6 months post randomisation
Incremental cost per QALY at 6 months
Measured: 6 months post randomisation
Care costs derived from data linkage during 5 years post-randomisation
Measured: 5 years post randomisation
Protocol compliance (during intervention index hospital stay)
Proportion of participants compliant with the study intervention as per protocol (%).
Measured: Throughout the study, for an average of 1 month
Hb concentration (during index hospital stay)
Measured: Throughout the study, for an average of 1 month
RBC use (during 3 months follow up)
Measured: 3 months post randomisation
New Infections (during 3 months follow-up)
Measured: 3 months post randomisation
Transfusion-related adverse events (during 3 months follow-up)
Measured: 3 months post randomisation
Major adverse cardiovascular events (MACE; during 3 months follow-up)
Measured: 3 months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Sep 2020
- Primary completion16 Jun 2025
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anemia AcuteStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591574
- Sponsor's protocol ID
- AC19089
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2020
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41244217Radford 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.
PubMed 38780066
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anaemia Management With Red Blood Cell Transfusion to Improve Post-intensive Care Disability: a Randomised Controlled Trial (The ABC Post-intensive Care Trial)
- ClinicalTrials.gov ID
- NCT04591574
- Acronym / sponsor ID
- AC19089
- Conditions
- Anemia Acute, Fatigue, Physical Disability, Quality of Life
- Keywords
- Post Intensive Care Recovery, Blood Transfusion, Physical Function, Moderate-Severe Anaemia, Systemic Inflammation, Impaired Erythrogenesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 346 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Other | Biological: Red Blood Cells (Transfusion)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. |
| Usual care group | Active comparator | Biological: Red Blood Cells (Transfusion)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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Intervention Group, Usual care group |
Primary outcome
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
17 secondary outcomes
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
Patient Fatigue (Fatigue Severity Scale (FSS)) at 1, 3 and 6 months post randomisation
Time frame: 6 months post randomisation
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
Activities of Daily Living (ADLs) (from WHODAS questionnaire) at 3 months post randomisation
Time frame: 3 months post randomisation
Patients alive at 1, 3, and 6 months post-randomisation
Time frame: 6 months post randomisation
Patients alive at 5 years post-randomisation derived from data linkage
Time frame: 5 years post randomisation
Haemoglobin concentration at 1 month post-randomisation
Time frame: 1 month post randomisation
Post-ICU length of hospital stay
Time frame: Variable according to patient's length of hospital stay
Care costs during 6 months post-randomisation
Time frame: 6 months post randomisation
Incremental cost per QALY at 6 months
Time frame: 6 months post randomisation
Care costs derived from data linkage during 5 years post-randomisation
Time frame: 5 years post randomisation
Protocol compliance (during intervention index hospital stay)
Time frame: Throughout the study, for an average of 1 month
Hb concentration (during index hospital stay)
Time frame: Throughout the study, for an average of 1 month
RBC use (during 3 months follow up)
Time frame: 3 months post randomisation
New Infections (during 3 months follow-up)
Time frame: 3 months post randomisation
Transfusion-related adverse events (during 3 months follow-up)
Time frame: 3 months post randomisation
Major adverse cardiovascular events (MACE; during 3 months follow-up)
Time frame: 3 months post randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Derived from this study: PubMed 41244217Walsh 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.
- Derived from this study: PubMed 38780066Radford 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Blood Cells (Transfusion) in people with Anemia Acute and Fatigue, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04591574, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.