Patient Blood Management Charité (PBM-Charité): ): Cohort Study About Structured Detection, Differentiated Diagnostics and Therapy of Preoperative Anemia and Use of Machine Autotransfusion in Elective Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,700
- 试验地点
- 1
- 主要终点
- Number of patients
研究概览
简要总结
The aim of patient blood management is to reduce the risks of perioperative anemia- and transfusion-associated complications by limiting the use and the need for allogeneic blood transfusion.
详细描述
Background of this multimodal, multidisciplinary concept are numerous studies that have shown an association between preoperative anemia and/or a perioperative transfusion and a worse treatment outcome concerning morbidity and mortality. Diagnosis and therapy of preoperative anemia and the use of machine autotransfusion are central components of this integrated supply concept based on the S3 guideline "Präoperative Anämie", which need to be incorporated into the clinical processes.
Therefore, all patients undergoing elective surgery with a probability of transfusion > 10% receive an anemia detection during their premedication visit. Patients who are insured with BARMER also get anemia diagnostic and therapy. Patients of other health insurances receive a recommendation to anemia diagnostics and therapy sent to surgical department. Based on an analysis of the primary and secondary endpoints of this prospective cohort study, the implementation of the mentioned guideline-compliant measures in everyday clinical practice and the effectiveness of an IV-PBM (Patient blood management) are to be examined. Thus, if necessary, other health insurances could join the patient blood management (PBM) IV concept. The aim is to provide evidence of an improved quality of treatment and the generalized application of PBM measures within the scope of the innovative PBM care form described.
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
- •age ≥ 18 years
- •male and female patients
- •patients eligible for inclusion: by the patient, preoperatively
- •patients who are insured with BARMER
- •patients with preoperative anemia and an elective (N5) surgical intervention with a probability of transfusion > 10%
- •additionally for the use of MAT:
- •indication of machine autotransfusion
- •high blood loss (> 500ml / 10-20 % of estimated blood volume) beside of indication interventions (surgery under dual platelet inhibition, high individual bleeding risk, special antibodies / rare blood group, rejection of allogeneic blood)
排除标准
- •patients with emergency interventions
- •rejection of study participation
- •pregnancy, elective caesarean section or breastfeeding
- •not enough German language skills
- •accommodation in an institution because of judicial or administrative order
- •employee of Charité
- •missing of declaration of consent
- •Retrospective:
- •Inclusion Criteria:
- •Data since September 2021-February 2024 of patients who are not insured with BARMER with elective (N5) interventions with a transfusion probability > 10% (indication list) with a preoperatively existing anemia
- •additionally for the use of MAT:
- •indication of machine autotransfusion
- •high blood loss (> 500ml / 10-20 % of estimated blood volume) beside of indication interventions (surgery under dual platelet inhibition, high individual bleeding risk, special antibodies / rare blood group, rejection of allogeneic blood)
结局指标
主要结局
Number of patients
时间窗: The participants are followed up until the end of hospital stay, an expected average of 7 days
The amount of patients with differential diagnostics and causally appropriate therapy of a preoperative anemia of all patients with preoperative anemia before an elective surgical intervention with a probability of transfusion \> 10% at study completion date = third year after start date (implementation rate of therapy recommendation). Approximately 9600 patients will be enrolled in the study. The data is evaluated after 3 years.
次要结局
- Rate and type of postoperative complications(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- ∆Hb before therapy of anemia and before surgical intervention(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Treatment dose of anemia therapeutics in relation to ∆Hemoglobin(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Anemia course(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Side effects 1(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Number of patients(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Treatment period(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Length of intensive care unit stay(The participants are followed up until the end of hospital stay, an expected average of 3 days)
- Quality indicator 1(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Quality indicator 5(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Rate of transfused patients(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Number of allogeneic transfusions(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Length of hospital stay(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Volumes of collected blood(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Quality indicator 4(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Number of machine autotransfusion respectively autologous transfusion(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Differences of secondary outcome measures(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Quality indicator 3(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Side effects 2(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Rate of side effects(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Retransfused blood(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Quality indicator 2(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Rate of In-hospital mortality(The participants are followed up until the end of hospital stay, an expected average of 7 days)
研究者
Claudia Spies
Head of the Department of Anesthesiology and operative Intensive Care (CCM/CVK), Charité- Universitätsmedizin Berlin
Charite University, Berlin, Germany