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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
United Kingdom
NHS Lothian
RECRUITING
Edinburgh
Contact Information
Primary
Trial Manager
ABC.Trial@ed.ac.uk
0131 651 9907
Time Frame
Start Date: 2020-09-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 346
Treatments
Other: 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.
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: University of Edinburgh
Collaborators: University of Oxford

This content was sourced from clinicaltrials.gov