Status:
COMPLETED
CArdio PulmOnary Exercise Testing and IntRAvenous Iron- 'CAPOEIRA-I STUDY'
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
University College, London
University of Bayreuth
Conditions:
Anemia
Anemia, Iron Deficiency
Eligibility:
All Genders
16-110 years
Brief Summary
Red blood cells contain a chemical called haemoglobin which carries oxygen from the lungs around the body. When the amount of haemoglobin is reduced, a patient is 'anaemic'. Anaemia can have many caus...
Detailed Description
Anaemia is common in the elective surgical population, a prevalence of around 30% being consistently reported in large cohorts. Cardiopulmonary exercise testing (CPET), which provides an objective as...
Eligibility Criteria
Inclusion
- Adult patients undergoing elective surgery
- Having a CPET as part of routine care
- Patients with a Hb value of \< 130 g/L who are iron deficient, iron restricted/deplete or have functional iron deficiency as described in 5.2 and Appendix 1
- Able to provide written informed consent.
- Patients with mixed aetiology anaemia who are either iron deficient, iron replete or functionally iron deficient alongside B12 or folate deficiency will be eligible for the study alongside treatment of their other nutritional deficiency.
Exclusion
- Pregnant women
- Prisoners
- Hypersensitivity to the active substance, to 'Monofer' (iron isomaltoside 1000) or any of its excipients
- Known documented serious hypersensitivity to any parenteral iron products
- Haemochromatosis or other iron overload states
- Acute liver or renal failure
- Active infection
- Those receiving a blood transfusion between the CPET tests
- Unable/ contraindication to perform CPET (Appendix 3)
- Haemoglobinopathies such as Sickle Cell Anaemia or Thalassemia
- Other cause for anaemia such as haematological malignancy, haemolysis, hypothyroidism.
Key Trial Info
Start Date :
February 2 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03346213
Start Date
February 2 2018
End Date
October 1 2018
Last Update
September 25 2019
Active Locations (1)
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1
University Hospital Southampton NHS Foundation trust
Southampton, England, United Kingdom, SO16 6YD