The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in hemoglobin concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: Ferric derisomaltose (Drug)
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.
干预措施: Ferrous succinate (Drug)
结局指标
主要结局
Change in hemoglobin concentration
时间窗: At 14 days
Change in hemoglobin concentrations from POD(postoperative day)1 to POD14
次要结局
- Fatigue score(At 35 days)
- Change in hemoglobin concentration(At 35 days)
- Change in serum iron(At 35 days)
- Change in ferritin(At 35 days)
- Correction of anemia(At 35 days)
- Adverse events(At 3 months)
- Barthel Index(At 35 days)
- Length of hospital stay(At 3 months)
- Change in soluble transferrin receptor(At 35 days)
- EQ-5D(At 35 days)
- Infection(At 3 months)
- Change in transferrin saturation(At 35 days)
研究者
Weiyun Chen
Principal Investigator
Peking Union Medical College Hospital