The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery
- Conditions
- Perioperative AnemiaAdultSurgerySpinal Deformity
- Interventions
- Registration Number
- NCT05714007
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group Ferric derisomaltose 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 Control group Ferrous succinate 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.
- Primary Outcome Measures
Name Time Method Change in hemoglobin concentration At 14 days Change in hemoglobin concentrations from POD(postoperative day)1 to POD14
- Secondary Outcome Measures
Name Time Method Change in hemoglobin concentration At 35 days Change in hemoglobin concentrations from POD1 to POD35
Change in ferritin At 35 days Change in ferritin from POD1 to POD35
Correction of anemia At 35 days The percentage of effective correction of anemia (elevation of Hb \>20g/L or Hb ≥120g/L) at POD35
Fatigue score At 35 days Fatigue measured FACIT-F questionnaire at POD35
Adverse events At 3 months Incidence of adverse events
Barthel Index At 35 days Independence in daily activities measured by the Barthel questionnaire at POD 35
Length of hospital stay At 3 months Hospitalized days
Change in soluble transferrin receptor At 35 days Change in soluble transferrin receptor from POD1 to POD35
EQ-5D At 35 days Quality of life measured by EQ-5D at POD35
Change in transferrin saturation At 35 days Change in transferrin saturation from POD1 to POD35
Infection At 3 months Incidence of postoperative infection
Change in serum iron At 35 days Change in serum iron from POD1 to POD35
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China