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

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: Pharmacosmos A/S
• Treatments: Ferrous succinate

Criteria

Inclusion Criteria

1. Age ≥18 years

2. Received spinal deformity surgery

3. 70 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 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.