Anaemia in survivors of intensive care MedDRA version: 20.0 Level: PT Classification code 10002034 Term: Anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0 Level: PT Classification code 10022519 Term: Intensive care System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Ferric carboxymaltose
Product Name: Ferric carboxymaltose
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ferric carboxymaltose
CAS Number: 1461680-64-7
Other descriptive n
Sponsors
University of Oxford / Clinical Trials and Research Governance
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a feasibility study aiming to find out whether it is possible to give intravenous (through a drip) iron to patients with anaemia (low blood count) who have survived intensive care (ICU). A feasibility study is a short trial with a small number of people taking part, to help us decide how a larger study would work. Important questions that we are asking in this feasibility study are (i) How easy is it to recruit participants? (ii) How easy is it to collect the relevant information we would need for a future large trial? Our ultimate aim is to complete a larger trial which will test whether or not intravenous iron will treat anaemia in ICU survivors and improve quality of life after discharge from hospital. This would require external funding and be a separate ethics application. ;Secondary Objective: Secondary outcomes will include collecting information on the following outcomes that we feel are important to both patients and doctors: (i) Clinical outcomes - new infection, hospital length of stay, readmission to intensive care and in-hospital death (ii) Laboratory outcomes - changes in blood counts and iron profiles (iii) Completion rates of health-related quality of life questionnaires (iv) Healthcare resource use after discharge from hospital We anticipate the information collected above will help us make calculations on how many patients we would need for a future, larger trial. ;Primary end point(s): The primary objective for this study is to assess the feasibility of a future large multicentre trial of intravenous iron to treat anaemia in ICU survivors. The following outcomes will be measured: (1) Recruitment and randomisation rates (2) Number of participants randomised to the study drug who actually go on to receive it (protocol adherence) (3) Completion rates of health related quality of life and health economic questionnaires ;Timepoint(s) of evaluation of this end point: The recruitment period is 52 weeks. Data will be collected at | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Clinical outcomes - new infection, mortality, hospital length of stay (LOS), ICU and hospital readmissions, blood product use (2) Laboratory data – changes from baseline to 28 and 90 days post-randomisation in the following – haemoglobin, iron profile (ferritin, serum iron, Transferrin saturation (Tsat (%)), urea and electrolytes (U&Es), liver function tests (LFTs), bone profile, C-reactive protein, erythropoietin (EPO), Vitamin D, hepcidin, soluble transferrin receptor (sTfR) (3) Healthcare resource use – primary healthcare use post-hospital discharge, societal costs and productivity losses (4) Health-related quality of life – MFI-20, FACIT-F and EQ-5D-5L questionnaires;Timepoint(s) of evaluation of this end point: The recruitment period is 52 weeks. Data will be collected at baseline (pre-randomisation) and at 28 and 90 days post-randomisation. | — |
Countries
United Kingdom
Contacts
Public ContactAkshay Shah
University of Oxford
Outcome results
None listed