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ABC - A Post Intensive Care Anaemia Management Trial

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of Dec 31, 2025 to Jun 16, 2025 · Site details revisedv6 Show 2 more changesShow less
    • Primary completion date changed from estimate of Dec 31, 2025 to Jun 16, 2025
    • Site details revised
  2. Notable Primary completion date: Mar 31, 2025 to Dec 31, 2025 Enrollment target: 305 to 346 · Completion date: Aug 31, 2025 to May 31, 2026 · Eligibility criteria expanded, about 33 wordsv5 Show 3 more changesShow less
    • Enrollment target: 305 to 346
    • Completion date: Aug 31, 2025 to May 31, 2026
    • Eligibility criteria expanded, about 33 words

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Re-verified, no change to tracked fieldsv4
  4. Notable Primary completion date: Nov 30, 2023 to Mar 31, 2025 Completion date: Nov 30, 2023 to Aug 31, 2025v3 Show 1 more changeShow less
    • Completion date: Nov 30, 2023 to Aug 31, 2025
  5. Notable Primary completion date: Nov 2021 to Nov 30, 2023 Completion date: Sep 2026 to Nov 30, 2023 · Start date: Sep 23, 2020 to Sep 1, 2020v2 Show 2 more changesShow less
    • Completion date: Sep 2026 to Nov 30, 2023
    • Start date: Sep 23, 2020 to Sep 1, 2020
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04591574
Lead Sponsor University of Edinburgh
Collaborators: University of Oxford
Conditions Anemia Acute, Fatigue, Physical Disability, Quality of Life
Enrollment 346 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov