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临床试验/NCT07314424
NCT07314424尚未招募4 期

The Effect of Preoperative Intravenous Ferric Derisomaltose and EPO and Tranexamic Acid Versus Usual Treatment in Patients With Preoperative Anemia or Iron Deficiency in Bone Tumor: a Single-center, Prospective, Open-label, RCT Study

Tang Xiaodong0 个研究点目标入组 160 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
160
主要终点
Hb levels 21 days after surgery

研究概览

简要总结

The pelvis and spine are common sites of primary and secondary bone tumors, and most patients require surgical treatment. However, due to bleeding, high tumor burden, and other reasons, iron deficiency anemia (IDA) is common in these patients. At present, allogeneic blood resources are scarce in China and even globally, and cancer patients cannot undergo autologous blood transfusion. In addition, there is a large amount of bleeding during pelvic and spinal open surgery, which collectively leads to a high incidence of perioperative anemia in patients with pelvic and spinal tumors, and even the loss of surgical opportunities. Therefore, perioperative blood management for bone tumor surgery is extremely important. The combination of intravenous iron and EPO has been proven to rapidly improve the hemoglobin levels of perioperative surgical patients in previous studies, but there is currently no research related to bone tumors. This study uses a single center, prospective, open label, randomized controlled clinical trial to explore the effects of preoperative application of intravenous isomaltose iron combined with erythropoietin and tranexamic acid compared to conventional treatment in patients with preoperative anemia or iron deficiency in bone tumor surgery, hoping to establish a standard paradigm for perioperative blood management in bone tumor patients.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Isomaltose Anhydride Iron Group

Experimental

Calculate the patient's iron requirement based on a simplified scale for the isomaltose iron group; Yibiao 150IU/kg subcutaneous injection, no treatment in the conventional treatment group; 0.5g of tranexamic acid is administered locally after dilution before surgical closure

干预措施: isomaltose iron (Drug)

结局指标

主要结局

Hb levels 21 days after surgery

时间窗: Day 21

次要结局

  • Blood transfusion rate within 21 days after surgery(Day 21)
  • Hb levels 14 days after surgery(Day 14)

研究者

发起方
Tang Xiaodong
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tang Xiaodong

professor

Peking University People's Hospital

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