INtravevous Iron to Treat Anaemia in CriTical Care Survivors (INTACT): a feasibility study

Phase 1

• Conditions: Anaemia in survivors of intensive care; MedDRA version: 20.0Level: PTClassification code 10002034Term: AnaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: LLTClassification code 10002062Term: Anaemia iron deficiencySystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: PTClassification code 10022519Term: Intensive careSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-000767-91-GB
• Lead Sponsor: niversity of Oxford / Clinical Trials and Research Governance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-14
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

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

(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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified