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

NCT ID: NCT05714007

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Perioperative Anemia; Surgery; Spinal Deformity; Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Ferric derisomaltose

Intervention Type: DRUG

Single intravenous dose ferric derisomaltose

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.

Group Type: ACTIVE_COMPARATOR

Ferrous succinate

Intervention Type: DRUG

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

Interventions

Ferric derisomaltose

Single intravenous dose ferric derisomaltose

Intervention Type: DRUG

Ferrous succinate

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

Intervention Type: DRUG

Other Intervention Names

MONOFER®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmacosmos A/S

INDUSTRY

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Weiyun Chen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weiyun Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Jianxiong Shen, MD

Role: STUDY_DIRECTOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianxiong Shen, MD

Role: CONTACT

sjxpumch@163.com

01069152701

Weiyun Chen, MD

Role: CONTACT

chenweiyun@pumch.cn

13691412863

Facility Contacts

Jianxiong Shen, MD

Role: primary

sjxpumch@163.com

References

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.

Reference Type: BACKGROUND

PMID: 38267243 (View on PubMed)

Other Identifiers

PUMCH-Fe

Identifier Type: -

Identifier Source: org_study_id