Patient Blood Management in the Approach to Prosthetic Surgery in Orthopedic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Reduction in transfusion patients
研究概览
简要总结
We have been well guided in the "Good use of blood" during major surgery for many years, reaching a percentage of 4% of patients transfused after elective prosthetic operations. Valid patient blood management must provide for the possibility of limiting/zeroing the transfusion risk dependent on preoperative anemia, and the national guideline on PBM (Patient blood management) also underlines this Hypothesis and relevance
详细描述
We want to analyse patients from a diagnostic point of view (occult blood, diverticulitis, gastrorrhagia) and from the point of view of laboratory parameters (blood count, serum iron, transferrinemia, ferritinemia, transferrin saturation) in ordr to be able to suggest the best approach in preparation to the intervention.
We want to evaluate the effectiveness of this approach, considering the proposed treatments (ferric carboxymaltose, chelated iron, folic acid, sideremil vita) and the transfusion result (or not) obtained
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for prosthetic surgery
- •Patients of both sexes over 40 years of age
- •Hemoglobin values <12 g% for females and 13 g% for males and/or % transferrin saturation < 10%
- •Willingness and ability to provide informed consent.
排除标准
- •Patients with Mediterranean anemia
- •Patients with coagulation disorders
- •Patients who do not sign the consent form
- •Pregnant or breastfeeding women (self-declaration)
- •Minor aged
研究组 & 干预措施
Long assumption
Assumpion of SideremilVita for 30 days
干预措施: sideremil vita cp (Dietary Supplement)
Standard assumption
Assumpion of SideremilVita for 15 days
干预措施: sideremil vita cp (Dietary Supplement)
结局指标
主要结局
Reduction in transfusion patients
时间窗: 7 days post-surgery
Evaluate the reduction of transfusions in anemic patients treated with SideremilVita, with comparison between a treatment for 30 days before the intervention (group B ), compared to patients assuming SideremilVita at 15 days before surgery (group A)
次要结局
未报告次要终点