Sucrosomial Vs Intravenous Iron for Preoperative Anemia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester
About this trial
50 patients with anemia scheduled for heart surgery or procedures will be randomized to receive either oral sucrosomial iron or standard-of-care intravenous iron before surgery to see if the oral iron is as effective as intravenous iron in increasing the red blood cell count.
Eligibility criteria
Qualifiers
Age ≥18 years
Coronary artery bypass graft surgery (CABG)
Valve procedures
Aortic root procedures
Disqualifiers
Scheduled for cardiac surgery requiring deep hypothermia or circulatory arrest
Undergoing heart transplantation or ventricular assist device placement
Lacking capacity to provide informed consent or unable to understand spoken and written English
Baseline hemoglobin >12 g/dL or <10 g/dL
Trial design
Treatments tested in this trial
- Treatment with oral sucrosomial iron
- Treatment with intravenous iron
Treatment groups
75 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Rochester
Lead sponsor
Pharmanutra S.p.a.
Collaborator
Source ClinicalTrials.gov