NCT02800746Unknown不适用
Preoperative Intravenous Iron Supplementation on Postoperative Hematocrit and Intraoperative Transfusion Amount in Prognathic Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 主要终点
- Serum-Hematocrit
研究概览
简要总结
The objective of the present study is to determine the impact of preoperative IV-iron (ferric carboxy maltose) supplementation on postoperative hematocrit values and allogenic blood transfusion amount in patients undergoing elective prognathic 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with prognathism in undergoing elective prognathic surgery
- •Patients provided a written informed consent.
- •Patients with s-ferritin < 300 mg/dl (male) or 200 mg/dl (female)
- •Patients with preoperative Hematocrit > 39% (male) and > 36% 9female)serum hemoglobin >13 g/dL (male) and >12 g/dL (female)
排除标准
- •Patients with history of anaphylaxis, iron overload, active infection.
- •Patients with endocrine disease
- •Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.
研究组 & 干预措施
Experimental group
Experimental
Ferric carboxymaltose
干预措施: Ferric carboxymaltose (Drug)
Control Group
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Serum-Hematocrit
时间窗: Postoperative 2 hour
intergroup-difference immediately after surgery, %
次要结局
- Serum-Ferritin level(Postoperative 2 hour)
- Changes of serum-Ferritin level(Postoperative 2 hour)
- Transfusion amount(Postoperative 2 hour)
研究者
Tae-Yop Kim, MD PhD
Professor
Konkuk University Medical Center
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