ABC - A Post Intensive Care Anaemia Management Trial

Status Recruiting

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04591574
Study type	Interventional
Source	University of Edinburgh
Contact	Trial Manager
Phone	0131 651 9907
Email	ABC.Trial@ed.ac.uk
Status	Recruiting
Phase	N/A
Start date	September 1, 2020
Completion date	August 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.