Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery
- Conditions
- HemorrhageBleeding
- Interventions
- Other: ROTEM-AlgorithmOther: Quantra-Algorithm
- Registration Number
- NCT03902275
- Lead Sponsor
- Johann Wolfgang Goethe University Hospital
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
>18 years elective operation with cardiac bypass
participation on another study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control ROTEM-Algorithm Evaluation of bloodsamples using the ROTEM and Multiplate device Quantra Quantra-Algorithm Evaluation of bloodsamples using the Quantra and Multiplate device
- Primary Outcome Measures
Name Time Method Bloodloss From finishing operation until 24 hours postoperative Cumulative bloodloss directly after surgery for 24h Determined by cumulative volume of all drains in millilitres
- Secondary Outcome Measures
Name Time Method Thromboembolic complications During operation within 24h postoperative Thromboembolic complications
Multiplate results During operation within 24 hours postoperative Determin platelet function with ADP test
Time saving by using a cassette During operation within 24 hours postoperative Influence of a cassette structure in comparison to pipetting with regard to the temporal availability of the measurement results
Correlations of parameters between POCT and laboratory parameters. During operation within 24h postoperative platelet count
Use of blood products During operation within 24 hours postoperative Cumulative volume of administered fresh frozen plasma, platelet infusion and packed red blood cells in mililitres
Coagulationfactos and procoagulant drugs During operation within 24 hours postoperative 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
Comorbidities 15 years before operation Comorbidities
Trial Locations
- Locations (1)
University Hospital Frankfurt
🇩🇪Frankfurt am Main, Hessen, Germany