NCT04078880已完成不适用
Sideral Forte in Prosthetic Hip and Knee Surgery
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2018年12月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Change of blood hemoglobin levels
研究概览
简要总结
Randomized controlled trial to evaluate the efficacy of oral iron supplementation in reducing the prevalence of preoperative anemia in a cohort of 82 patients undergoing elective prosthetic hip or knee surgery.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •ASA 1, 2, or 3
- •No neuropsychiatric conditions
- •Acceptance of informed consent
- •Elective prosthetic hip or knee surgery
排除标准
- •Present or past neuropsychiatric conditions
- •Hip or knee revision surgery
- •Use of iron as dietary supplement
- •Known erythrocytosis
- •Incompatible hypersensitivities
- •Iron metabolism disorders
- •Lymphoproliferative disorders
结局指标
主要结局
Change of blood hemoglobin levels
时间窗: Baseline and 30 days +/- 5 days
CHange of hemoglobin concentration (g/dl) from baseline and after 30 days +/- 5 days
次要结局
未报告次要终点
研究者
研究点 (1)
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