Evaluation of Fixed and Personal Assets for Patient Blood Management Implementation in CEE Countries in Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Was the PBM training able to significantly reduce the use of blood products in the audited periods?
研究概览
简要总结
The goal of the study is data collection on available fixed and personal assets required for Patient Blood Management (elements of the 3 pillars of PBM) in Central Eastern Europe countries hospitals, status before and after PBM training.
详细描述
The goals of the PBM program:
- Improving patient care and optimizing blood management - quality assurance
- bleeding management based on latest scientific guidelines including:
- reduction of transfusion and better outcomes
- optimization of blood reserves
- introduction and acceptance of hospital protocols Previous research has identified gaps concerning implementation of PBM elements in CEE region calling for further research and training: anemia is not being managed appropriately, there are no protocols in place, patient journey is not clearly defined, it is not clear at which department should be anemia treated; availability of POC devices varies largely among countries; local protocols for management of severe bleeding are also missing in many hospitals.
Investigators plan to collect PBM implementation indicators in hospitals before PBM training at a given start point as baseline (first self audit) and re-evaluate achievements after 6 months after training (second self audit).
Investigators plan to define 2x1 week "snapshot" period for detailed analysis of perioperative approach at patient level (1 week at the beginning of the study and 1 week after 6 month).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients above 18 years of age
- •patients undergoing elective medium and high bleeding risk surgical intervention defined as moderate (<500 ml) and high (≥ 500 ml)
- •patient consent
排除标准
- •no patient consent
- •patients under 18 years of age
- •pregnant patients
- •surgery with a low risk of bleeding
- •the patient underwent emergency (non-elective) surgery
结局指标
主要结局
Was the PBM training able to significantly reduce the use of blood products in the audited periods?
时间窗: second self audit versus first self audit ( 6 months)
Identification of local and country level PBM gaps during the first self audit followed by training and corrective measures, reidentification of remaining local and country level PBM gaps during the second self audit: 1. Reduction of RBC, FFP and TC in Units 2. PBM trained physichian in number
次要结局
- Material assets for the PBM pillars(second self audit versus first self audit ( 6 months))
- Impact of PBM implementation on postoperative care(second self audit versus first self audit ( 9 months))
- PBM implementation impact on infection rates(second self audit versus first self audit ( 6 months))
- PBM implemetnation impact on mortality(second self audit versus first self audit ( 6 months))
研究者
Dr. Fazakas János
Associate Professor
Semmelweis University