Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to develop a coagulation algorithm based on Quantra POCT for the treatment of coagulopathic cardiac surgery patients.

Detailed 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.

Official Title
-----------------
Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery

Conditions
-----------------
Hemorrhage, Bleeding

Intervention / Treatment
-----------------
* Other: Quantra-Algorithm
* Other: ROTEM-Algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years elective operation with cardiac bypass Exclusion Criteria: participation on another study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quantra<br>Evaluation of bloodsamples using the Quantra and Multiplate device | Other: Quantra-Algorithm<br>* Hemotherapy based on Quantra-Algorithm<br>|
| Active Comparator: Control<br>Evaluation of bloodsamples using the ROTEM and Multiplate device | Other: ROTEM-Algorithm<br>* Hemotherapy based on Basic-Algorithm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bloodloss | Cumulative bloodloss directly after surgery for 24h Determined by cumulative volume of all drains in millilitres | From finishing operation until 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations of parameters between POCT and laboratory parameters. | Quick | During operation within 24 hours postoperative | 
| Correlations of parameters between POCT and laboratory parameters. | prothrombine time | During operation within 24 hours postoperative | 
| Correlations of parameters between POCT and laboratory parameters. | activated partial thromboplastin time | During operation within 24 hours postoperative | 
| Correlations of parameters between POCT and laboratory parameters. | Firbinogen | During operation within 24 hours postoperative | 
| Correlations of parameters between POCT and laboratory parameters. | platelet count | During operation within 24h postoperative | 
| Multiplate results | Determin platelet function with TRAP test | During operation within 24 hours postoperative | 
| Multiplate results | Determin platelet function with ASPI test | During operation within 24 hours postoperative | 
| Multiplate results | Determin platelet function with ADP test | During operation within 24 hours postoperative | 
| Time saving by using a cassette | Influence of a cassette structure in comparison to pipetting with regard to the temporal availability of the measurement results | During operation within 24 hours postoperative | 
| Use of blood products | Cumulative volume of administered fresh frozen plasma, platelet infusion and packed red blood cells in mililitres | During operation within 24 hours postoperative | 
| Coagulationfactos and procoagulant drugs | Cumulative usage of prothrombin complexe concentrate measured in international units, fibrinogen measured in gramm, tranexamic acid measured in gramm, desmopressin measured in microgramm, Calcium measured in gramm, activated factor VII measured in international units | During operation within 24 hours postoperative | 
| Thromboembolic complications | Thromboembolic complications | During operation within 24h postoperative | 
| Comorbidities | Comorbidities | 15 years before operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, bleeding, point of care testing, POCT, algorithm based therapy