EUCTR2020-001389-12-DK
Active, not recruiting
Phase 1
The Postoperative Iron in Cardiac Surgery (PICS-) trial:A randomised clinical trial comparing the efficacy of single-, high-dose intravenous iron and oral iron for the treatment of anaemia following cardiac surgery. - PICS-trial
Aarhus University Hospital0 sites110 target enrollmentSeptember 3, 2020
ConditionsAnaemia following cardiac surgeryMedDRA version: 22.0Level: LLTClassification code 10057220Term: Acute post haemorrhagic anaemiaSystem Organ Class: 100000004851MedDRA version: 20.0Level: LLTClassification code 10022974Term: Iron deficiency anemiaSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Anaemia following cardiac surgery
- Sponsor
- Aarhus University Hospital
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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