The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ferric derisomaltose, Ferrous succinate.
- Who it may be relevant to
- Registry conditions: Perioperative Anemia, Surgery, Spinal Deformity, Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study
Overview
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.
Interventions
- Drug Ferric derisomaltose
Single intravenous dose ferric derisomaltose - Drug Ferrous succinate
Daily oral dose of 100 mg iron (ferrous succinate) tid postoperatively
Primary outcome measures
- Change in hemoglobin concentration [Time frame: At 14 days]
Secondary outcome measures (12)
- Change in hemoglobin concentration [Time frame: At 5 days]
- Change in hemoglobin concentration [Time frame: At 35 days]
- Correction of anemia [Time frame: At 5 days]
- Correction of anemia [Time frame: At 14 days]
- Correction of anemia [Time frame: At 35 days]
- Change in serum iron [Time frame: At 5 days]
- Change in serum iron [Time frame: At 14 days]
- Change in serum iron [Time frame: At 35 days]
- Change in ferritin [Time frame: At 5 days]
- Change in ferritin [Time frame: At 14 days]
- Change in ferritin [Time frame: At 35 days]
- Change in transferrin saturation [Time frame: At 5 days]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
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. PMID 38267243
Identifiers
NCT: NCT05714007 · PUMCH-Fe