Clinical trial NCT04591574: ABC - A Post Intensive Care Anaemia Management Trial
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2020-10-19
Enrollment: 305
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Physical component score (PCS) of the SF-36 Health Related Quality of Life (HRQoL) questionnaire at 3 months post randomisation
timeFrame: 3 months post randomisation
Secondary outcomes:
measure: PCS of the SF-36 HRQoL questionnaire (and its four sub-domains) at 1 and 6 months post randomisation.
timeFrame: 6 months post randomisation
measure: Patient Fatigue (Fatigue Severity Scale (FSS)) at 1, 3 and 6 months post randomisation
timeFrame: 6 months post randomisation
measure: Mental Component Score of SF-36 (and its four sub-domains) at 1, 3 and 6 months post randomisation
timeFrame: 6 months post randomisation
measure: Activities of Daily Living (ADLs) (from WHODAS questionnaire) at 3 months post randomisation
timeFrame: 3 months post randomisation
measure: Patients alive at 1, 3, and 6 months post-randomisation
timeFrame: 6 months post randomisation
measure: Patients alive at 5 years post-randomisation derived from data linkage
timeFrame: 5 years post randomisation
measure: Haemoglobin concentration at 1 month post-randomisation
timeFrame: 1 month post randomisation
measure: Post-ICU length of hospital stay
timeFrame: Variable according to patient's length of hospital stay
measure: Care costs during 6 months post-randomisation
timeFrame: 6 months post randomisation
measure: Incremental cost per QALY at 6 months
timeFrame: 6 months post randomisation
measure: Care costs derived from data linkage during 5 years post-randomisation
timeFrame: 5 years post randomisation
measure: Protocol compliance (during intervention index hospital stay)
timeFrame: Throughout the study, for an average of 1 month
measure: Hb concentration (during index hospital stay)
timeFrame: Throughout the study, for an average of 1 month
measure: RBC use (during 3 months follow up)
timeFrame: 3 months post randomisation
measure: New Infections (during 3 months follow-up)
timeFrame: 3 months post randomisation
measure: Transfusion-related adverse events (during 3 months follow-up)
timeFrame: 3 months post randomisation
measure: Major adverse cardiovascular events (MACE; during 3 months follow-up)
timeFrame: 3 months post randomisation
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
Study officials:
References: