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临床试验/NCT00199277
NCT00199277Unknown4 期

Randomized, Parallel Group, Clinical Trial Comparing Intravenous Iron Sucrose Versus Oral Ferrous Sulphate in the Treatment of Perioperative Iron Deficiency in Patients With Colo-Rectal Neoplasm and Iron Deficiency Anemia.

J. Uriach and Company5 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2005年9月20日最近更新:
适应症
相关药物

试验速览

阶段
4 期
发起方
入组人数
150
试验地点
5
主要终点
Preoperative variations in hemoglobin.

研究概览

简要总结

The main objective of this study is to evaluate the efficacy of intravenous iron sucrose in increasing preoperative haemoglobin values in patients with colo-rectal neoplasm and iron deficiency anemia, compared to the standard treatment with oral iron. It will also determine whether intravenous iron sucrose administration improves outcomes such as postoperative haemoglobin values, serum ferritin values, transfusional needs, postoperative complications, or length of hospital stay.

详细描述

Most patients with colorectal neoplasm have iron deficiency, which can be triggered in the pre-operative period by a decrease of iron intake and the bleeding in the site of neoplasm.

In the postoperative period, iron deficiency can be aggravated by surgical bleeding.

Iron plays a leading rol in haemoglobin production, cell mitosis and immune system. Animal experimentation has shown that induced iron deficiency and mild anemia lead to postoperative mortality and lactacidemia in a model of peritonitis.

Moreover, anemia is the main risk factor to require intra and postoperative blood transfusions, and iron deficiency and anemia are associated to a larger number of postoperative complications (infections and longer hospital stay).

Oral iron therapy is the standard treatment in patients with preoperative iron deficiency, but iron levels inside red cells may not reach normality in time before surgery, and it can not be resumed until the patient can start again oral feeding.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-recurrent colorectal neoplasm, surgically resectable

排除标准

  • Severe renal impairment
  • High anesthetic risk

结局指标

主要结局

Preoperative variations in hemoglobin.

次要结局

  • - Infections
  • - Reintervention
  • - Death
  • Length of hospital stay
  • Postoperative variations in hemoglobin.
  • Blood transfusion needs (pre, intra and postoperative)
  • Postoperative complications:
  • - Pulmonary thromboembolism

研究者

发起方
J. Uriach and Company
申办方类型
Industry

研究点 (5)

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