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NCT05714007
The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery
Conditions: Perioperative Anemia, Surgery, Spinal Deformity, Adult
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 98
Sponsor: Peking Union Medical College Hospital
Location: China
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 i.v.
ferric derisomaltose 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 Criteria
Inclusion CriteriaAge ≥18 yearsReceived spinal deformity surgery70 g/L ≤ Hb ≤ 110 g/L at POD1, or Hb ≤120 g/L at POD1 with a decrease in Hb of ≥20 g/L compared with baselineInformed consent was obtained voluntarilyExclusion CriteriaWomen who are pregnant, breastfeeding, or planning to become pregnant.known serious hypersensitivity to other parenteral iron productsNon-iron deficiency anemia (e.g., hemolytic anemia)Decompensated liver insufficiencyCoexisting active infectionDrug abuse, including but not limited to opioids, amphetamines, methamphetamine, ketamine, etc.Other conditions that the investigator considers inappropriate for participation (e.g.
deafness, Parkinson's disease, communication disorders, etc.)Participation in another clinical trial within three months prior to this study.
Source: ClinicalTrials.gov (NCT05714007). StuddyBuddy aggregates publicly available trial information.