ABC Post ICU

Our trial will be the first to find out if an ICU patient’s health can be improved by treating their anaemia using blood transfusions from the time they leave the ICU. We will compare the current approach, which is to leave people more anaemic, with a more active approach of using blood transfusions to correct anaemia during the time they spend in hospital after leaving ICU. Patients will be randomly split into two groups and the allocated approach will be used from the time they leave ICU until they are discharged from hospital. We will measure the effect that treating anaemia with blood transfusions has on important patient outcomes such as quality of life, the ability to carry out daily tasks, symptoms of fatigue, and patients’ physical ability. Our trial will also explore which patients benefit most from blood transfusions and those who gain no benefit. We aim to establish which anaemic patients to treat with blood transfusions after ICU to help their recovery.

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Chief Investigator: Professor Timothy Walsh

Number and location of participating sites / geographical scope (by region/ country): UK – 15 sites

Funder: JP Moulton Foundation Trust

Start and End date

Of grant award:  1 Nov 2019 - 31 August 2025

Of recruitment: Grant start date: September 2020

Current Status: Recruitment open in Edinburgh, set-up of other sites in Spring 2022

UK GDPR Privacy Statement: Information can be found in our Patient Information Sheets.

You can find out more about how we use your information:

• at www.hra.nhs.uk/information-about-patients/  

• our leaflet available from www.hra.nhs.uk/patientdataandresearch

• by asking one of the research team

• by sending an email to  the ABC.Trial@ed.ac.uk email address, or the Data Protection Officer: Rena.Gertz@ed.ac.uk

• by ringing us on 0131 651 9923

Study Protocol:

Example Patient Information Sheet (Scotland):

Example Patient Information Sheet (Rest of UK):

REDCap Database:

https://redcap.clinicaltrials.ed.ac.uk/

ABC Post ICU frequently asked questions:

ABC Post ICU Patient Video v1.0 08Aug2023

ABC Post ICU Rationale for Clinicians

ABC Post ICU Autumn Relaunch 25^th October 2023

Co-enrolment between ABC Post ICU and the following CTIMP studies has been agreed: A2B, ABBRUPT, ABC Sepsis, ADD-Aspirin, EVIS, GuARDS, INFINIT, MARCH, MOSAICC, PARAMEDIC-3, SINFONIA, SWIFT, SNAP-IT, VARICiSS, VITDALIZE, TRAITS – platform agreed, TRAITS – trial specific platform LYMPH-RESP (budesonide / baricitinib) agreed, TRAITS – trial specific platform ENDO SHOCK (imatinib) agreed. Should you have any queries regarding platform trials, please contact ABC.Trial@ed.ac.uk and Jo.Singleton@nhs.scot.

Co-enrolment between ABC Post ICU and the following non-CTIMP studies has been agreed: A prospective, single arm, multiple-centre study of the ENSEAL X1 curved jaw tissue selar and generator G11 in thoracic, urologic and ear nose and throat procedures, Adapt Sepsis, AFAR, , Autoflow, BIGPAK2 (only where patients are at least 72 hours post-surgery), Biomarkers associated with Postoperative Cognitive Dysfunction, CandiRes, Cognishine, CONDUCT ICU, DRESSINg, EMU, FREECycl-D, GI DAMPS, Inference, iRehab, NOTE-AF, PREFIBRILLATE, PQIP, REACT SHOCK, Rossini 2, Scottish Colorectal Cancer Genetic Susceptibility Study 3 (SOCCS3), SHORTER, SR1418 SSCAMP, T4P, UK-ROX, VITAL

Co-enrolment between ABC Post ICU and the following observational/sampling studies has been agree: ARDS-Neut (participants in both PHIND & ARDS-Neut can also be co-enrolled), A-STOP, GenOMMIC, IMPROVE, KRAKIL, PHIND

Sponsor: The University of Edinburgh and Lothian Health Board, ACCORD (ref: AC18022), The Queen’s Medical Research Institute, 47 Little France Crescent, Edinburgh EH16 4TJ.  http://accord.scot/

Chief Investigator: Professor Timothy Walsh Timothy.Walsh@ed.ac.uk

Trial manager:  Rachel Locherty, contact the trial team on: ABC.Trial@ed.ac.uk

ECTU Involvement: Trial Management /Statistics/ Database and randomisation service.

(UKCRC)