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临床试验/NCT03902275
NCT03902275终止不适用

Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery

Johann Wolfgang Goethe University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

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

Experimental

Evaluation of bloodsamples using the Quantra and Multiplate device

干预措施: Quantra-Algorithm (Other)

Control

Active Comparator

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

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med. Florian Raimann

Principal investigator

Johann Wolfgang Goethe University Hospital

研究点 (1)

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