Condition category
Haematological Disorders
Date applied
16/07/2018
Date assigned
17/07/2018
Last edited
21/09/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Anaemia is a reduction in the amount of haemoglobin in the blood. Haemoglobin is responsible for carrying oxygen in the blood. Anaemia is very common in patients during and after an intensive care unit (ICU) stay. Recent research has shown that that many patients who leave the ICU and subsequently the 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 it is not known 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. The aim of this small study is to recruit around 130 participants across two large hospitals in Oxford and Edinburgh to see if a bigger study, involving hundreds more patients, is possible. The bigger study would test whether or not giving an injection of iron through a vein (intravenous) after ICU can treat anaemia (increase a patient's blood count) and make patients feel better when they are recovering at home.

Who can participate?
Adult patients who have been in the ICU for over 48 hours, are now deemed fit for discharge, and have low haemoglobin

What does the study involve?
Participants are randomly allocated to receive either iron through a vein (intravenous) or no iron. Extra blood samples (2-3 teaspoons worth) are taken to measure levels of iron and participants are asked to complete health questionnaires on three separate occasions: at the start of the study and after 28 and 90 days.

What are the possible benefits and risks of participating?
Potential benefits to patients include correction of anaemia with potential improvements in fatigue symptoms. Participants from both groups may benefit from increased observation, data collection and event monitoring as is common to other participants in research studies. The risks of participating are the possible side effects of receiving intravenous iron. The most common reported side effects are nausea and headache. Other known side effects which may occur are dizziness, high blood pressure, and/or injection site reactions.

Where is the study run from?
1. John Radcliffe Hospital (UK)
2. Edinburgh Royal Infirmary (UK)

When is the study starting and how long is it expected to run for?
October 2017 to June 2020

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Akshay Shah
Akshay.shah@ndcls.ox.ac.uk

Trial website

https://www.octru.ox.ac.uk/trials/trials-in-set-up/intact

Contact information

Type

Public

Primary contact

Dr Akshay Shah

ORCID ID

http://orcid.org/0000-0002-1869-2231

Contact details

Nuffield Department of Clinical Laboratory Sciences
University of Oxford
Level 4 Academic Block
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 387906
Akshay.shah@ndcls.ox.ac.uk

Additional identifiers

EudraCT number

2018-000767-91

ClinicalTrials.gov number

Protocol/serial number

38731

Study information

Scientific title

INTACT: a randomised feasibility study of INtravenous iron versus usual care to Treat Anaemia in CriTical care survivors

Acronym

INTACT

Study hypothesis

The primary objective of this study is to assess the feasibility of a future large multicentre trial of intravenous iron to anaemia in survivors of intensive care.

Ethics approval

South Central - Berkshire B Research Ethics Committee, 07/07/2018, ref: 18/SC/0308

Study design

Randomised; Interventional; Design type: Treatment, Drug

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Critical Care, Primary sub-specialty: Critical Care; UKCRC code/ Disease: Blood/ Other diseases of blood and blood-forming organs

Intervention

Eligible participants will be randomised at the baseline visit to receive either intravenous iron or usual care using minimisation on a secure web-based system. Minimisation variables will include anaemia severity (Hb <80 g/l vs Hb 80 - 100 g/l) and ICU length of stay (<7 days vs ≥ 7 days)

Intervention group: Participants will receive a one-dose dose of intravenous ferric carboxymaltose (dose 1000 mg) as an infusion over a minimum of 15 minutes. This will be administered at any point between ICU and hospital discharge.

Control group: Participants will not receive intravenous iron from the research team. Any decision to commence iron therapy in this group would be at the discretion of the responsible clinical team and independent of the study.

Both groups will receive usual medical care.

Intervention type

Drug

Phase

Phase II

Drug names

Ferric carboxymaltose

Primary outcome measure

1. Recruitment and randomisation rates at baseline
2. Protocol adherence, defined as the number of participants allocated to the study drug who actually go on to receive it between randomisation and hospital discharge
3. Completeness of outcome data collection; completion of health-related quality of life (HRQoL) and healthcare resource use questionnaires at baseline and at 28 and 90 days post-randomisation

Secondary outcome measures

1. Clinical data on in-hospital mortality, length of stay and new infection will be collected from baseline to hospital discharge
2. Changes in laboratory haematological (e.g. haemoglobin) and iron profiles (e.g. ferritin) from baseline to 28 and 90 days post-randomisation
3. Changes in fatigue and HRQoL scores, using the MFI-20, FACIT-F and EQ-5D-5L questionnaires, from baseline to 28 and 90 days post-randomisation
4. Healthcare resource use (e.g. direct, indirect and total costs for the NHS from societal and payers perspective) measured using a bespoke questionnaire at 28 and 90 days post-randomisation

Overall trial start date

03/10/2017

Overall trial end date

01/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult ICU/HDU (Level 2 or 3) for ≥48 hours and now deemed fit for discharge by the attending physician
2. Last measured laboratory haemoglobin ≤100 g/l
3. Able to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 130; UK Sample Size: 130

Participant exclusion criteria

1. Planned palliative care
2. Planned home ventilation
3. Primary neurological diagnosis
4. Requirement for English translation
5. Known hypersensitivity to iron
6. Immunosuppressive therapy for organ transplant
7. Intravenous iron or erythropoietin in the previous 4 weeks
8. Weight < = 50 kg
9. Already enrolled into another trial where the trial protocol explicitly prohibits co-enrolment
10. Pregnancy (however, breastfeeding is not an exclusion criteria)
11. Personal or family history of iron overload disorders such as haemachromatosis or previously documented ferritin > 1200 ng.ml-1 and/or Tsat > 50%
12. History of severe asthma, eczema, or other atopic allergy
13. Chronic liver disease and/or screening Alanine Transferase / Aspartate Transferase x3 above upper limit of normal range
14. Haemodialysis dependent chronic kidney disease
15. Acute infection – non-resolving temperature > = 38°C within the past 24 hours or patient on non-prophylactic antibiotics
16. Patients residing outside a reasonable geographic follow-up area (e.g. defined as within approximately 30 miles of the John Radcliffe Hospital or Edinburgh Royal Infirmary)

Recruitment start date

18/09/2018

Recruitment end date

31/07/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Edinburgh Royal Infirmary
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Trainees Co-ordinating Centre (TCC); Grant Codes: DRF-2017-10-094

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists plan to publish their study protocol in an appropriate peer-reviewed journal before study completion. They plan to publish their findings in a high-impact peer reviewed journal by June 2021.

IPD sharing statement
Whilst the trialists intend to share participant level data, the data sharing plans have as yet not been fully formulated and will be made available at a later date.

Intention to publish date

01/06/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/09/2018: The recruitment start date was changed from 01/08/2018 to 18/09/2018.