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