The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years
• Received spinal deformity surgery
• 70 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
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Jianxiong Shen, MD
sjxpumch@163.com
01069152701
Backup
Weiyun Chen, MD
chenweiyun@pumch.cn
13691412863
Time Frame
Start Date:2023-08-31
Estimated Completion Date:2025-12
Participants
Target number of participants:120
Treatments
Experimental: Treatment group
Iron to be administered as intravenous ferric derisomaltose:~Where Hb (hemoglobin) ≥100 g/L, dosage according to body weight is as follows:~Body weight \<50 kg: 500mg; Body weight 50 to \<70 kg: 1000 mg; Body weight ≥70 kg: 1500 mg.~Where Hb \<100 g/L, dosage according to body weight is as follows:~Body weight \<50 kg: 500mg; Body weight 50 to \<70 kg: 1500mg; Body weight ≥70 kg: 2000 mg.~The maximial dose should not exceed 20mg/kg body weight, rounded off to the nearest 100mg
Active_comparator: Control group
Iron to be administered as oral ferrous succinate:~1 tablet (100 mg) tid (three times daily), starting on the first postoperative day and continuing for 4 weeks.
Who is this study for: Children 0 to <18 years of age with iron deficiency anemia due to NDD-CKD or with iron deficiency anemia who are intolerant or unresponsive to oral iron