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The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 13, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Jun 2025 to Dec 2025 Publications: details revised at 1 of 1 entry · Eligibility criteria shortened, about 4 wordsv8 Show 2 more changesShow less
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 2023 to Aug 31, 2023 · Site details revisedv7 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2023 to Aug 31, 2023
    • Site details revised
  3. Enrollment target: 98 to 120v6
  4. Primary and study completion dates: Oct 2024 to Jun 2025 Start date: May 2023 to Jul 2023v5 Show 1 more changeShow less
    • Start date: May 2023 to Jul 2023
  5. Start date: Mar 2023 to May 2023v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Feb 2023 to Mar 2023v3
  2. Secondary endpoints: details revised at 6 of 29 entries Study description expanded, about 4 wordsv2 Show 1 more changeShow less
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The prognosis of patients undergoing spinal deformity surgery is often compromised by perioperative anemia due to iron deficiency. The aim of this randomized, controlled trial was to evaluate whether postoperative ferric derisomaltose intravenous injection may improve anemia and prognosis in patients undergoing spinal deformity surgery comparing with oral iron. Participants will be randomly assigned to the treatment group (intravenous ferric derisomaltose) and the control group (oral iron). Changes in hemoglobin concentration, percentage of anemia correction, changes in iron indicators, patient quality of life, and incidence of adverse events will be analyzed to evaluate the efficacy and safety of iron isomaltoside infusion.
Trial Details
NCT Number NCT05714007
Lead Sponsor Peking Union Medical College Hospital
Collaborators: Pharmacosmos A/S
Conditions Perioperative Anemia, Surgery, Spinal Deformity, Adult
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov