Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Bloodloss
研究概览
简要总结
The aim of this study is to develop a coagulation algorithm based on Quantra POCT for the treatment of coagulopathic cardiac surgery patients.
详细描述
In order to perform a targeted coagulation therapy during intra- and postoperative care of cardiosurgical patients, it is necessary to know the hemostatic potential. After blood samples have been taken for coagulation diagnosis, they are usually sent to the central laboratory. After analysis and validation, the results are transmitted electronically. The loss of time due to sample transport, analysis and provision of the results prolongs the time required to derive therapeutic measures.
In recent years, point of care testing (POCT) devices for the diagnosis of coagulopathic patients have become increasingly important. In our clinic, POCT devices have been routinely used for intra- and postoperative targeted coagulation therapy for years. These include the ROTEM delta and Multiplate. For analysis, a whole blood sample is pipetted together with test reagents. Depending on the selected reagent, different parts of the coagulation cascade can be evaluated and, depending on this, an appropriate therapy can be derived. A coagulation algorithm developed in our clinic is based on these measurement results and has been used successfully for years for perioperative coagulation management. This algorithm requires additional information on the platelet function, which is also carried out as standard on the bed side using multi-plate analysis as POCT.
A new system for whole blood analysis has recently become available on the market. The Quantra from HemoSonics also allows the analysis of a whole blood sample on the bed side. Due to the cassette structure, the time-consuming and potentially error-prone pipetting of a whole blood sample is no longer necessary. The aim of this study is to develop a coagulation algorithm based on Quantra POCT for the treatment of coagulopathic cardiac surgery patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>18 years elective operation with cardiac bypass
排除标准
- •participation on another study
研究组 & 干预措施
Quantra
Evaluation of bloodsamples using the Quantra and Multiplate device
干预措施: Quantra-Algorithm (Other)
Control
Evaluation of bloodsamples using the ROTEM and Multiplate device
干预措施: ROTEM-Algorithm (Other)
结局指标
主要结局
Bloodloss
时间窗: From finishing operation until 24 hours postoperative
Cumulative bloodloss directly after surgery for 24h Determined by cumulative volume of all drains in millilitres
次要结局
- Multiplate results(During operation within 24 hours postoperative)
- Thromboembolic complications(During operation within 24h postoperative)
- Time saving by using a cassette(During operation within 24 hours postoperative)
- Correlations of parameters between POCT and laboratory parameters.(During operation within 24h postoperative)
- Use of blood products(During operation within 24 hours postoperative)
- Coagulationfactos and procoagulant drugs(During operation within 24 hours postoperative)
- Comorbidities(15 years before operation)
- Correlations of parameters between POCT and laboratory parameters.(During operation within 24 hours postoperative)
研究者
Dr. med. Florian Raimann
Principal investigator
Johann Wolfgang Goethe University Hospital
