EUCTR2018-004213-41-BE进行中（未招募）1 期
Effect of intravenous replenishment of iron in the preoperative management of anemia in patients with colon cancer: RIPAC-trial - RIPAC-trial
niversity Hospital Ghent0 个研究点目标入组 60 人开始时间: 2019年5月6日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with a M0-stage colon carcinoma who are scheduled for segmental colonic resection
- •Patients with a Hb higher than 6.5 g/dl or 7.5 g/dl in patients with cardiac disease at moment of diagnosis
- •Patients with a proven iron deficiency anemia defined by a Hb lower than 13g/dl in men and 12g/dl in women with a transferrin saturation lower than 20%.
- •Obtained informed consent
- •=18 years; female or male
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 51
排除标准
- •The period between diagnosis and surgery is less than two weeks
- •Hemochromatosis, iron overload, defined as TSAT > 45%
- •Known hypersensitivity to Injectafer®
- •Metastatic colon disease
- •Patients not suitable for surgery due to age or comorbidities
- •Pregnancy, lactation or woman of childbearing potential who don’t use an effective method of contraception
- •Administration of IV iron/oral iron/ESA in the past three months before inclusion
- •Administration of blood transfusion in the past month before inclusion
- •Chronic kidney disease with a eGFR < 30 ml/min
- •Hematological disorders as a cause of anemia (myelodysplastic syndrome, leukemia, chronic hemolysis)
- •Vitamin B12 and/or serum folate deficiency
- •Patients undergoing endoscopic excision of a (rectal) carcinoma (EMR/ESD)
研究者
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Effects of intravenous administered iron in non-anemic iron deficient patients with colorectal cancer.Iron-deficiency in colorectal cancerMedDRA version: 20.0Level: PTClassification code 10009944Term: Colon cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10038038Term: Rectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2019-003819-56-DKCentre for Surgical Science134
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