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Sucrosomial Vs Intravenous Iron for Preoperative Anemia

Study acronym: RSIVI
StatusWithdrawn
PhasePhase 4
Started
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Record History

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  1. Withdrawn before enrolling Sponsor's reason: Study withdrawn due to lack of funding and the company's decision not to pursue the IND. No participants were enrolled. Show 6 more changesShow less
    • Enrollment target: estimated 75 to confirmed 0
    • Start date: Dec 31, 2025 to Dec 1, 2026
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Site contact updated
    • Publications: details revised at 5 of 5 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07287371
Lead Sponsor University of Rochester
Collaborators: Pharmanutra S.p.a.
Conditions
(from sponsor)		 Anemia, Iron Deficiency Anemia
Related terms Anemia, Anemia, Iron-Deficiency
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov