A41
Conditions
Interventions
Group 1: Ex vivo studies using blood from patients with sepsis
Group 2: Ex vivo studies using blood from healthy volunteers
Group 3: Ex vivo studies using blood from healthy volunteers to which LPS ha
Sponsors
Universitätsklinikum Dresden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ICD diagnosis: sepsis or septic shock
Exclusion criteria
Exclusion criteria: Failure to meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are: (1) the change in thrombin generation (Endogenous Thrombin Potential [ETP], peak thrombin, lag time) in response to different antithrombin concentrations under basal conditions and following ex vivo stimulation with lipopolysaccharide (LPS); (2) the normalisation of thrombin generation through the combination of defined antithrombin concentrations with unfractionated heparin, low-molecular-weight heparin, argatroban or lysis; and (3) effluent thrombus formation in the BioFlux microfluidic system and the expression of tissue factor on endothelial cells following incubation with plasma or whole blood from healthy volunteers or septicaemic patients. The endpoints are assessed once on ex vivo blood samples or on plasma and cell preparations derived from them. The measurements are carried out using calibrated thrombin generation assays, BioFlux microfluidics and standardised laboratory procedures. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in standard and advanced coagulation parameters, including thrombin-antithrombin and plasmin-antiplasmin complexes, markers of the endothelial glycocalyx and endothelial activation, as well as inflammatory markers, under the various experimental conditions. In addition, parameters of the BioFlux microfluidic system, including clot formation, flow behaviour and time to occlusion, are recorded. All secondary endpoints are determined once on ex vivo blood samples or plasma and cell preparations derived from them, using standardised laboratory analyses and the BioFlux microfluidic system. | — |
Countries
Germany
Contacts
Public ContactLars Heubner
Universitätsklinikum Dresden
Outcome results
None listed