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Clinical Trials/EUCTR2018-000767-91-GB
EUCTR2018-000767-91-GB
Active, not recruiting
Phase 1

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 sites130 target enrollmentJune 14, 2018

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Oxford / Clinical Trials and Research Governance
Enrollment
130
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 14, 2018
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity of Oxford / Clinical Trials and Research Governance

Eligibility 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

  • (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)

Outcomes

Primary Outcomes

Not specified

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