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Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery

Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03902275
Enrollment
20
Registered
2019-04-04
Start date
2019-07-01
Completion date
2020-06-01
Last updated
2020-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Hemorrhage

Keywords

cardiac surgery, bleeding, point of care testing, POCT, algorithm based therapy

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.

Interventions

OTHERQuantra-Algorithm

Hemotherapy based on Quantra-Algorithm

OTHERROTEM-Algorithm

Hemotherapy based on Basic-Algorithm

Sponsors

HemoSonics LLC
CollaboratorINDUSTRY
Johann Wolfgang Goethe University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\>18 years elective operation with cardiac bypass

Exclusion criteria

participation on another study

Design outcomes

Primary

MeasureTime frameDescription
BloodlossFrom finishing operation until 24 hours postoperativeCumulative bloodloss directly after surgery for 24h Determined by cumulative volume of all drains in millilitres

Secondary

MeasureTime frameDescription
Multiplate resultsDuring operation within 24 hours postoperativeDetermin platelet function with TRAP test
Time saving by using a cassetteDuring operation within 24 hours postoperativeInfluence of a cassette structure in comparison to pipetting with regard to the temporal availability of the measurement results
Use of blood productsDuring operation within 24 hours postoperativeCumulative volume of administered fresh frozen plasma, platelet infusion and packed red blood cells in mililitres
Correlations of parameters between POCT and laboratory parameters.During operation within 24 hours postoperativeQuick
Thromboembolic complicationsDuring operation within 24h postoperativeThromboembolic complications
Comorbidities15 years before operationComorbidities
Coagulationfactos and procoagulant drugsDuring operation within 24 hours postoperativeCumulative 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026