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临床试验/NCT06026618
NCT06026618进行中(未招募)不适用

Perioperative Management of Preoperative Anemia in Colorectal Cancer. Effect of Intravenous Iron Treatment Within a Patient Blood Management on Colorectal Cancer Surgery

Consorci Sanitari Integral1 个研究点 分布在 1 个国家目标入组 1,294 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,294
试验地点
1
主要终点
Change in Hemoglobin

研究概览

简要总结

Both preoperative anemia (PA) and perioperative blood transfusion can contribute on poorer outcomes after colon cancer surgery. Anemia is known to be associated with a slower recovery after surgery thus often worsening short-term results, and allogenic red blood cells transfusion (ARBT) are known to promote systemic inflammatory response and affect overall and cancer-specific survival.

Patient Blood Management (PBM) systems are an evidence-based multimodal approach focused on safe and rational use of blood products, mainly through a proper PA assessment, a minimization of procedural blood loos and strict transfusion policies. Given the high prevalence of PA in patients with colorectal cancer (CRC), and its association with adverse events, it is expected that PBM implementation in said scenario carries a decrease in complications and an improved survival rate. Available literature to date supports preoperative anaemia screening and restrictive transfusion policies, nevertheless barriers exist that limit the expected implementation of PBM systems in colorectal surgery.

The present study aims to evaluate feasibility of a PBM pathway implementation in a high-volume CRC Surgery Unit based on completion of anemia screening and treatment before surgery and changes of allogenic products use along the years. The objective is to estimate the impact of a proper preoperative optimization with iron intravenous infusion (IVI) on PA measured from changes Hemoglobin (Hb) levels in comparison to those of non-anemic patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

  • Patients diagnosed with Colorectal Cancer
  • Patients with an indication of elective radical surgery

排除标准

  • treatment with red blood cells transfusion before assessment in the PBM Anemia Clinic
  • non-iron deficient anemia
  • treatment with Sucrose-based IVI or Oral Iron (OI) preparations not strictly controlled by the PBM clinic

结局指标

主要结局

Change in Hemoglobin

时间窗: Baseline and up to 30 days

Change in serum hemoglobin concentration between baseline (at the moment of initial colorectal clinic visit) and day of surgery

次要结局

  • Total iron dose(up to 30 days)
  • number of days needed to complete treatment(up to 30 days)
  • number of complications related to IVI administration(up to 30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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