RecruitingPhase 4NCT05714007

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

The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study

Sponsor

Peking Union Medical College Hospital

Enrollment

120 participants

Start Date

Aug 31, 2023

Study Type

INTERVENTIONAL

Conditions

Surgery Adult Spinal Deformity Perioperative Anemia

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

Min Age: 18 Years

Inclusion Criteria5

Age ≥18 years
Received spinal deformity surgery
g/L ≤ Hb ≤ 110 g/L at POD1, or Hb at POD1 showed a decrease of
≥20 g/L compared with baseline
Informed consent was obtained voluntarily

Exclusion Criteria8

Women who are pregnant, breastfeeding, or planning to become pregnant.
known serious hypersensitivity to other parenteral iron products
Non-iron deficiency anemia (e.g., hemolytic anemia)
Decompensated liver insufficiency
Coexisting active infection
Drug 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.

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