INtravenous Iron to Treat Anaemia in CriTical Care (INTACT)
Research type
Research Study
Full title
INtravenous Iron to Treat Anaemia in CriTical Care Survivors (INTACT): a feasibility study
IRAS ID
238406
Contact name
Akshay Shah
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Eudract number
2018-000767-91
Clinicaltrials.gov Identifier
U1111-1209-6873, WHO Universal Trial Number (UTN)
Duration of Study in the UK
1 years, 7 months, 2 days
Research summary
Research Summary
Anaemia is a reduction in the amount haemoglobin in the blood. Haemoglobin is responsible for carrying oxygen in the blood. Anaemia is very common in patients during and after an ICU stay. Recent research has shown that that many patients who leave ICU and subsequently hospital with anaemia are still anaemic even up to 6 months after leaving hospital.
Symptoms of anaemia include feeling tired (fatigue), lacking energy (lethargy), and shortness of breath. These symptoms are very common and distressing to ICU survivors and whilst these could be symptoms of anaemia they may also be related to other complications of having been ill in ICU. At present we do not which is the best way to treat anaemia after ICU and as a result many patients do not receive any investigations or treatment for this. Recently, there have been a few small studies that suggest giving an injection of iron to patients that have spent time in ICU may be beneficial to their recovery, but more evidence is needed.
We are aiming to recruit around 130 participants across two large hospitals in Oxford and Edinburgh into a small feasibility study to see if a bigger study, involving hundreds more patients, is possible. In the bigger study, we would test whether or not giving an injection of iron through a vein (intravenous) after intensive care (ICU) can treat anaemia (increase a patient's blood count) and make patients feel better when they are recovering at home.
Participants will be randomised (allocated by chance) to receive either iron through a vein (intravenous) or no iron. We will also take some extra blood samples (2-3 teaspoons worth) to measure in-depth levels of iron and ask participants to complete health questionnaires on three separate occasions – before randomisation, and at 28 and 90 days after randomisation.
Summary of Results
This research was for patients who survive a stay in an intensive care unit (ICU) with a low red blood cell count - a condition known as anaemia.
Every year, around 260,000 adults are treated in an ICU, and up to 100,000 patients have anaemia when they leave ICU. Our previous research has shown that anaemia makes these patients feel tired and weak, leading to longer hospital stays and difficulties getting by at home after leaving hospital.
In this study, we wanted to see if iron given through a drip (intravenously) can help the body make red blood cells in patients who are recovering from a stay. It is a safe treatment that is already used in the NHS to treat anaemia in other conditions such as heart and kidney disease.
We enrolled 98 adult ICU survivors. We found that patients who had their anaemia treated went home from hospital quicker, and were less likely to return to hospital afterwards. The treatment was also safe with no serious side effects reported. Although our results are encouraging, we now need a larger study to confirm these benefits.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0308
Date of REC Opinion
19 Jun 2018
REC opinion
Favourable Opinion