跳至主要内容
临床试验/NCT07057973
NCT07057973招募中不适用

The Effectiveness of Preoperative Iron Therapy in Improving Anemia After Multi-level Lumbar Fusion in the Elderly

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
the levels of hemoglobin

研究概览

简要总结

Preoperative iron therapy has important value in improving the outcomes after lumbar fusion surgery, but there is significant heterogeneity in both domestic and international studies. International studies provide high-level evidence-based evidence for intravenous iron, but lack spinal surgery-specific data; domestic studies focus on the comparison of iron types and the improvement of clinical practice, but high-quality evidence is still insufficient. At present, there are still few studies on preoperative iron therapy in the field of spinal surgery, especially its specific impact on the prognosis of patients after lumbar fusion surgery is still unclear. Therefore, it is particularly important to study the preoperative iron supplementation regimen for lumbar fusion surgery to improve the efficacy and safety. Through multidisciplinary collaboration and technological innovation, preoperative iron therapy is expected to become an important part of accelerated recovery after lumbar fusion surgery.

详细描述

Preoperative iron therapy has important value in improving the outcomes after lumbar fusion surgery, but there is significant heterogeneity in both domestic and international studies. International studies provide high-level evidence-based evidence for intravenous iron, but lack spinal surgery-specific data; domestic studies focus on the comparison of iron types and the improvement of clinical practice, but high-quality evidence is still insufficient. At present, there are still few studies on preoperative iron therapy in the field of spinal surgery, especially its specific impact on the prognosis of patients after lumbar fusion surgery is still unclear. Therefore, it is particularly important to study the preoperative iron supplementation regimen for lumbar fusion surgery to improve the efficacy and safety. Through multidisciplinary collaboration and technological innovation, preoperative iron therapy is expected to become an important part of accelerated recovery after lumbar fusion surgery.

This study aimed to investigate the correlation between ferric carboxymaltose and iron deficiency anemia (IDA) patients with or without concurrent iron therapy on hemoglobin changes, 90-day adverse events, and satisfactory health-related quality of life (HRQOL) indicators after multilevel lumbar spine fusion.

Outcome measures

  1. Differences in hemoglobin and iron metabolism indicators (serum iron, ferritin, transferrin, transferrin saturation) levels on the 1st, 4th, 7th day after surgery and at discharge
  2. Differences in the incidence of adverse events and length of hospital stay within 90 days after lumbar multilevel fusion surgery Any adverse event (AAE): serious or minor adverse event Serious adverse events (SAE): pulmonary embolism, wound infection, deep vein thrombosis, sepsis, myocardial infarction, neurological complications, delirium, septic shock, reoperation Minor adverse events (MAE): wound dehiscence, hematoma, other wound complications, acute kidney injury, blood transfusion, cerebrospinal fluid leak, urinary tract infection, pneumonia
  3. Study-specific surveys conducted at the time of assessment included the following health status-related quality of life scores (HRQOL): Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and EuroQol-5D (EQ-5D), 36-Item Short Form Health Survey (SF-36)

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients underwent multi-segment lumbar spine surgery;
  • IDA patients aged 65 years or older (male: Hb < 120g/dL; female: Hb < 110g/dL);
  • All patients completed the relevant questionnaire survey;

排除标准

  • Age less than 65 years old;
  • Previous surgery for spinal tumors, trauma or infection;
  • Inflammatory or immune diseases (such as rheumatoid arthritis or systemic lupus erythematosus), acute kidney injury, progressive cancer and porphyria cutanea tarda);
  • Non-adjacent segment surgery;
  • History of allergy to ferric carboxymaltose or any intravenous iron preparations, asthma, atopic dermatitis or allergy;
  • Decompensated cirrhosis and microcytic anemia;
  • Incomplete clinical data;

研究组 & 干预措施

Ferric carboxymaltose

Experimental

Ferric carboxymaltose treatment

干预措施: Ferric carboxymaltose (Drug)

结局指标

主要结局

the levels of hemoglobin

时间窗: on the first, fourth, and seventh days after surgery and at four weeks

the levels of hemoglobin

the level of iron metabolism indicators (serum iron, ferritin, transferrin, and transferrin saturation)

时间窗: on the first, fourth, and seventh days after surgery and at 4 weeks

the level of iron metabolism indicators (serum iron, ferritin, transferrin, and transferrin saturation)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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