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Clinical Trials in China / NCT05714007
Recruiting Phase 4

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

NCT05714007 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Phase 4
Started
2023-08-31
Last updated
2025-06-13

Condition(s) studied

Perioperative AnemiaSurgerySpinal DeformityAdult

Investigational drug(s) / intervention(s)

Ferric derisomaltose →Ferrous succinate →

Ferric derisomaltose: Single intravenous dose ferric derisomaltose

Ferrous succinate: Daily oral dose of 100 mg iron (ferrous succinate) tid postoperatively

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria 1. Age ≥18 years 2. Received spinal deformity surgery 3. 70 g/L ≤ Hb ≤ 110 g/L at POD1, or Hb at POD1 showed a decrease of ≥20 g/L compared with baseline 4. Informed consent was obtained voluntarily Exclusion Criteria 1. Women who are pregnant, breastfeeding, or planning to become pregnant. 2. known serious hypersensitivity to other parenteral iron products 3. Non-iron deficiency anemia (e.g., hemolytic anemia) 4. Decompensated liver insufficiency 5. Coexisting active infection 6. Drug abuse, including but not limited to opioids, amphetamines, methamphetamine, ketamine, etc. 7. Other conditions that the investigator considers inappropriate for participation (e.g. deafness, Parkinson's disease, communication disorders, etc.) 8. Participation in another clinical trial within three months prior to this study.

Primary outcome measure(s)

  • Change in hemoglobin concentration — At 14 days
    Change in hemoglobin concentrations from POD(postoperative day)1 to POD14

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05714007 on ClinicalTrials.gov ↗ ← All trials in China