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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Spinal Deformity; Adult; Perioperative Anemia
• Intervention / Treatment: Drug: Ferric derisomaltose; Drug: Ferrous succinate

Detailed Description

Iron deficiency is a common cause of perioperative anemia in patients undergoing spinal deformity surgery. Anemia may lead to increased postoperative complications and mortalities, prolonged hospital stays, deteriorated physical function, and severely affect the quality of life.

Oral iron has been widely recommended to treat perioperative anemia. However, the pro-inflammatory cytokines (such as IL-6 (Interleukin-6), TNF-a (Tumor necrosis factor-α)) produced by the inflammatory state after surgery can lead to an increase in hepcidin, which greatly affects the absorption of oral iron. Compared to oral iron, intravenous iron can circumvent the effects of decreased iron absorption in the gastrointestinal tract due to the postoperative inflammatory state and achieve faster and more effective iron supplementation. At present, intravenous iron supplements are mainly second-generation products, including iron sucrose and ferric gluconate. However, the unstable molecular structure of second-generation iron supplements may cause oxidative stress, which limits its administration in large doses.

Compared with traditional intravenous iron, the third-generation iron preparations allow more iron (1000 mg (milligram) or more, no more than 20 mg/kg (kilogram)) to be infused within a short period of time (15-60 minutes), improving patient compliance, reducing costs and complications caused by multiple infusions, and is promising to improve anemia more rapidly. Ferric derisomaltose, as the only third-generation iron currently available in China market, has showed its value in treating anemia in joint replacement surgeries. However, the effectiveness of postoperative intravenous ferric derisomaltose in spinal deformity surgery remains uncertain. Therefore, we designed this prospective randomized trial to evaluate whether intravenous ferric derisomaltose may improve anemia and prognosis in patients undergoing spinal deformity surgery compared with oral iron.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jianxiong Shen, MD; Phone Number: 01069152701; Email: sjxpumch@163.com
• Study Contact Backup: Name: Weiyun Chen, MD; Phone Number: 13691412863; Email: chenweiyun@pumch.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Jianxiong Shen, MD; Email: sjxpumch@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Age ≥18 years
2. Received spinal deformity surgery

3. 70 g/L ≤ Hb ≤ 110 g/L at POD1, or Hb at POD1 showed a decrease 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Ferrous succinate; Daily oral dose of 100 mg iron (ferrous succinate) tid postoperatively
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	Drug: Ferric derisomaltose; Single intravenous dose ferric derisomaltose; Other Names: MONOFER®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin concentration	Change in hemoglobin concentrations from POD(postoperative day)1 to POD14	At 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin concentration	Change in hemoglobin concentrations from POD1 to POD5	At 5 days
Change in hemoglobin concentration	Change in hemoglobin concentrations from POD1 to POD35	At 35 days
Correction of anemia	The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb ≥120g/L) at POD5	At 5 days
Correction of anemia	The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb ≥120g/L) at POD14	At 14 days
Correction of anemia	The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb ≥120g/L) at POD35	At 35 days
Change in serum iron	Change in serum iron from POD1 to POD5	At 5 days
Change in serum iron	Change in serum iron from POD1 to POD14	At 14 days
Change in serum iron	Change in serum iron from POD1 to POD35	At 35 days
Change in ferritin	Change in ferritin from POD1 to POD5	At 5 days
Change in ferritin	Change in ferritin from POD1 to POD14	At 14 days
Change in ferritin	Change in ferritin from POD1 to POD35	At 35 days
Change in transferrin saturation	Change in transferrin saturation from POD1 to POD5	At 5 days
Change in transferrin saturation	Change in transferrin saturation from POD1 to POD14	At 14 days
Change in transferrin saturation	Change in transferrin saturation from POD1 to POD35	At 35 days
Change in soluble transferrin receptor	Change in soluble transferrin receptor from POD1 to POD5	At 5 days
Change in soluble transferrin receptor	Change in soluble transferrin receptor from POD1 to POD14	At 14 days
Change in soluble transferrin receptor	Change in soluble transferrin receptor from POD1 to POD35	At 35 days
Barthel Index	Independence in daily activities measured by the Barthel questionnaire at POD 5	At 5 days
Barthel Index	Independence in daily activities measured by the Barthel questionnaire at POD 14	At 14 days
Barthel Index	Independence in daily activities measured by the Barthel questionnaire at POD 35	At 35 days
Length of hospital stay	Hospitalized days	At 3 months
Adverse events	Incidence of adverse events	At 3 months
Infection	Incidence of postoperative infection	At 3 months
EQ-5D	Quality of life measured by EQ-5D (European Quality of Life-5 Dimensions) at POD5	At 5 days
EQ-5D	Quality of life measured by EQ-5D at POD14	At 14 days
EQ-5D	Quality of life measured by EQ-5D at POD35	At 35 days
Fatigue score	Fatigue measured FACIT-F (The Functional Assessment of Chronic Illness Therapy-Fatigue) questionnaire at POD5	At 5 days
Fatigue score	Fatigue measured FACIT-F questionnaire at POD14	At 14 days
Fatigue score	Fatigue measured FACIT-F questionnaire at POD35	At 35 days

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Pharmacosmos A/S
• Investigators: Principal Investigator: Weiyun Chen, MD, Peking Union Medical College Hospital; Study Director: Jianxiong Shen, MD, Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: adult; spinal deformity surgery; perioperative anemia; ferric derisomaltose
• Additional Relevant MeSH Terms: Hematologic Diseases; Congenital Abnormalities; Anemia; Hematinics; Ferrous succinate
• Other Study ID Numbers: PUMCH-Fe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Coded data is anticipated to be shared with potential collaborators.
• IPD Sharing Time Frame: Anticipated that data from the study will become available within 5 years after publication of main data.
• IPD Sharing Access Criteria: Data would only be shared with IRB approved collaborators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No