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Clinical Trials/NL-OMON56336
NL-OMON56336
Recruiting
Not Applicable

INTRAVENOUS IRON TO TREAT POSTOPERATIVE ANEMIA IN OLDER CARDIAC SURGERY PATIENTS: A RANDOMIZED CONTROLLED TRIAL - AGE anemia

Sint Antonius Ziekenhuis0 sites310 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Sint Antonius Ziekenhuis
Enrollment
310
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Mentally competent with age \>\= 70 years
  • •Elective aortic valve replacement or coronary artery surgery
  • •Expected uncomplicated postoperative trajectory, defined as:
  • •\- No inotropic agents or ventilation at time of final inclusion (day 1\)
  • •\- Expected discharge to general ward at day 1
  • •Moderate postoperative iron deficiency anemia, defined as:
  • •\- Hb between 85 and 110 g/L and
  • •\- Ferritin \<100 µg/L or
  • •\- Iron saturation \< 20%

Exclusion Criteria

  • •Medical history of iron overload/haemochromatosis
  • •Medical history of liver cirrhosis or ALT/AST value in blood serum triple of
  • •normal value (female patients: ALT \>120, AST \>105 U/L. Male patients: ALT\>150,
  • •AST\>135 U/L)
  • •Severe renal failure (eGFR\<15ml/min/1\.73m2\)
  • •Recent treatment with IVI (\<12 weeks prior)
  • •Serious or severe allergic reaction to IVI in medical history
  • •Severe asthma or eczema in medical history (atopic constitution)

Outcomes

Primary Outcomes

Not specified

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