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)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
Beijing Municipality
Recruiting
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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.
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