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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 4

Conditions: Adult; Surgery; Spinal Deformity; Perioperative Anemia

Treatments: Drug: Ferric derisomaltose; Drug: Ferrous succinate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05714007

PUMCH-Fe

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Treatment group

Experimental group

Description:

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

Treatment:

Drug: Ferric derisomaltose

Control group

Active Comparator group

Description:

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.

Treatment:

Drug: Ferrous succinate