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临床试验/CTRI/2025/05/087381
CTRI/2025/05/087381尚未招募不适用

AN AUDIT TO EVALUATE THE EFFECTIVENESS OF INTRAVENOUS HEMATINICS THERAPY IN PERIOPERATIVE OUTCOMES IN MAJOR ABDOMINAL ONCOSURGERIES

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2025年2月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
350
试验地点
1
主要终点
Increase in mean Hemoglobin value after preoperative intravenous therapy to treat anaemia

研究概览

简要总结

Anemia, a condition where the blood lacks enough healthy red blood cells to carry oxygen, is common in cancer patients scheduled for major abdominal surgeries. It affects 30–60% of these patients and can lead to complications such as increased need for blood transfusions, delayed recovery, and longer hospital stays. Traditional treatments like oral iron supplements often fail to address this anemia effectively because cancer and related conditions interfere with how the body processes and uses iron.

This study aims to explore the use of intravenous (IV) iron therapy to treat anemia before surgery. Unlike oral supplements, IV iron bypasses the barriers caused by inflammation and allows for faster correction of anemia. By improving hemoglobin before surgery, we hope to reduce the need for blood transfusions during or after the operation, lower the risk of complications, and speed up recovery.

Over one year, we will monitor cancer patients undergoing elective abdominal surgeries at our hospital. We will examine how effective IV iron therapy is in improving hemoglobin levels, reducing blood transfusions, and ensuring better overall outcomes. This research is especially important in countries like India, where anemia is highly prevalent, and effective management could significantly improve peri-operative outcomes.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Haemoglobin less than 12g/dl in females and less than 13g/dl in males 2.All elective major abdominal oncosurgeries (Upper and lower gastrointestinal surgeries, Hepatico-pancreatico-biliary surgeries, Urological and Gynaecological surgeries) 3.Patients over the age of 18 years.

排除标准

  • 1.Emergency surgery 2.H/o allergy to parenteral iron preparations 3.Patients with recurrent or second primary cancer 4.Palliative surgery 5.Patients with chronic liver disease, chronic kidney disease, iron storage disorder, haematological malignancy and hemoglobinopathies.

结局指标

主要结局

Increase in mean Hemoglobin value after preoperative intravenous therapy to treat anaemia

时间窗: Hb at first visit, Preoperative Hb, Postoperative Hb

次要结局

  • 1.To study the effect of intravenous haematinics on the number of PRBC transfusions during and within 72 hours after surgery in comparison with patients without iron therapy(2.Incidence of anemia in patients undergoing major abdominal oncosurgeries)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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