Intravenous iron for the treatment of anaemia following cardiac surgery

Phase 1

• Conditions: Anaemia following cardiac surgery; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; MedDRA version: 22.0Level: LLTClassification code 10057220Term: Acute post haemorrhagic anaemiaSystem Organ Class: 100000004851; MedDRA version: 20.0Level: LLTClassification code 10022974Term: Iron deficiency anemiaSystem Organ Class: 100000004851

• Registration Number: EUCTR2020-001389-12-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-03
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Patients undergoing first-time, non-emergent cardiac surgery
2. Moderate anemia on the first postoperative day (i.e. a haemoglobin concentration of = 5.0 mmol/l [8 g/dl] and < 6.8 mmol/l [11 g/dl])
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Absolute and relative contraindications to treatment with intravenous iron
Treatment with intravenous iron within 4 weeks prior to surgery.
Untreated vitamin B12 or folate deficiency.
Anticipated inability to perform a six-minute walk test.
Women of childbearing potential, pregnant and nursing women.
Anticipated postoperative length of stay in the intensive care unit (ICU) > 48 hours.
Patients incapable of giving consent personally.
Significantly increased risk of non-adherence or loss to follow-up.
Active participation in another interventional trial with potential impact on postoperative anaemia or exercise capacity.

Study & Design

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