Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery

Johann Wolfgang Goethe University Hospital

Status: Terminated

Conditions: Hemorrhage; Bleeding

Treatments: Other: ROTEM-Algorithm; Other: Quantra-Algorithm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03902275

42/19

Details and patient eligibility

About

The aim of this study is to develop a coagulation algorithm based on Quantra POCT for the treatment of coagulopathic cardiac surgery patients.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

>18 years elective operation with cardiac bypass

Exclusion criteria

participation on another study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Quantra

Experimental group

Description:

Evaluation of bloodsamples using the Quantra and Multiplate device

Treatment:

Other: Quantra-Algorithm

Control

Active Comparator group

Description:

Evaluation of bloodsamples using the ROTEM and Multiplate device

Treatment:

Other: ROTEM-Algorithm