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

niversity of Oxford / Clinical Trials and Research Governance0 个研究点目标入组 130 人开始时间: 2018年6月14日最近更新: 2020年10月13日

试验速览

暂无简介。

•(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

•(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)

发起方

niversity of Oxford / Clinical Trials and Research Governance