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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study

Conditions
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Perioperative Anemia, Surgery, Spinal Deformity, Adult

Intervention / Treatment
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* Drug: Ferric derisomaltose
* Drug: Ferrous succinate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age ≥18 years Received spinal deformity surgery 70 g/L ≤ Hb ≤ 110 g/L at POD1, or Hb ≤120 g/L at POD1 with a decrease in Hb 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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<br>* Single intravenous dose ferric derisomaltose<br>* Other names: MONOFER®;|
| Active Comparator: Control group<br>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<br>* Daily oral dose of 100 mg iron (ferrous succinate) tid postoperatively<br>|

What is the study measuring?
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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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal deformity surgery, perioperative anemia, ferric derisomaltose, adult