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

NCT05714007 | Recruiting Phase 4 DMC

• 1 other identifier: PUMCH-Fe
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perioperative Anemia; Surgery; Spinal Deformity; Adult

Keywords

spinal deformity surgery; perioperative anemia; ferric derisomaltose; adult

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin concentration

  Change in hemoglobin concentrations from POD(postoperative day)1 to POD14

  At 14 days

Secondary Outcomes (29)

• Change in hemoglobin concentration

  At 5 days

• Change in hemoglobin concentration

  At 35 days

• Correction of anemia

  At 5 days

• Correction of anemia

  At 14 days

• Correction of anemia

  At 35 days

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Drug: Ferric derisomaltose

Control group

ACTIVE COMPARATOR

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.

Drug: Ferrous succinate

Interventions

Ferric derisomaltose DRUG

Single intravenous dose ferric derisomaltose

Also known as: MONOFER®

Treatment group

Ferrous succinate DRUG

Daily oral dose of 100 mg iron (ferrous succinate) tid postoperatively

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Pharmacosmos A/S: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• Zhan J, Jiao Y, Chen W, Huang Y, Shen J. Effects of ferric derisomaltose on postoperative anaemia in adult spinal deformity surgery: a study protocol for a randomised controlled trial. BMJ Open. 2024 Jan 24;14(1):e080952. doi: 10.1136/bmjopen-2023-080952.

  PMID: 38267243 BACKGROUND

MeSH Terms

Interventions

ferric derisomaltose; ferrous succinate

Study Officials

• Weiyun Chen, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Jianxiong Shen, MD

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Central Study Contacts

Jianxiong Shen, MD

CONTACT

01069152701; sjxpumch@163.com

Weiyun Chen, MD

CONTACT

13691412863; chenweiyun@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: August 31, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Anticipated that data from the study will become available within 5 years after publication of main data.
• Access Criteria: Data would only be shared with IRB approved collaborators.

Locations

CN (1)