The ClotPro analyzer is a new generation viscoelastic analyzer for the in vitro assessment of blood coagulation. This study aims to assess the agreement of ClotPro 6.0, ROTEM delta, and TEG 6s in three distinct cohorts: i) patients with liver disease undergoing liver surgery, ii) pregnant women undergoing elective cesarean section, and iii) patients undergoing elective intracranial neurosurgery. Further coagulation tests will be performed (standard laboratory coagulation tests, thrombin and plasmin generation tests) in an exploratory fashion to compare them with viscoelastic test results. The obtained test results will not result in any diagnostic or therapeutic consequences for patients included in this study.
Vulnerable patient cohorts
Liver resection (anatomic or non-anatomic segmental resection, right or left hepatectomy, right or left extended hepatectomy),
Orthotopic liver transplantation,
Pregnant women undergoing an elective caesarean section, and
None
The study population will be comprised of three groups: 1. Patients with liver disease undergoing elective liver surgery defined as one of the following invasive procedures a) liver resection (anatomic or non-anatomic segmental resection, right or left hepatectomy, right or left extended hepatectomy) or b) orthotopic liver transplantation. 2. Pregnant women undergoing elective cesarean section. 3. Patients undergoing elective intracranial neurosurgery
Cohort
Prospective
Viscoelastic testing
Diagnostic testviscoelasting testing refers to a global hemostatic assay,that quantifies the viscoelastic properties of citrated whole blood
Limits of agreement viscoelastic test parameters
Calculate limits of agreement between the following corresponding viscoelastic test parameters: * EX-test- clotting time vs. EXTEM-clotting time vs. citrated rapid TEG r time * EX-test- maxium clot firmness vs. EXTEM-maximum clot firmness vs. citrated rapid TEG-maximum amplitude * FIB-test-clotting time vs. FIBTEM-clotting time vs. citrated functional fibrinogen r time * FIB-test-maxium clot firmness vs. FIBTEM-maxium clot firmness vs. citrated functional fibrinogen-maximal amplitude
In depth hemostatic assessment: Viscoelastic tests (VET) & thrombin generation assay (with thrombmodulin)
Correlation between the following viscoelastic test parameters and thrombin generation (TG) measurements: \- Ex-test clotting time, citrated rapid TEG r time and the ratio of endogenous thrombin potential derived by TG assay using thrombomodulin
In depth hemostatic assessment: Viscoelastic tests (VET) & standard laboratory coagulation tests (SLT)
Correlation between the following VET parameters and SLT measurements: * EX-test clotting time and citrated rapid TEG r time vs. prothrombin time and * FIB-test maximum clot firmness, citrated functional fibrinogen-maximal amplitude and citrated functional fibrinoge- functional level of fibrinogen vs. Clauss fibrinogen.
In depth hemostatic assessment: Viscoelastic tests & plasmin generation (PG)
Correlation between the viscoelastic test parameters TPA-lysis time and TPA-maximal lysis with the endogenous plasmin potential derived by plasmin generation measurements.
Patient cohort-specific reference ranges
This anaylsis aims to investigate whether there is a need for cohort-specific reference ranges for ClotPro by assessing the distributional differences of ClotPro results between three patient cohorts (patients undergoing liver surgery, pregnant women undergoing elective cesarean section, patients undergoing an elective intracranial neurosurgery)
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Medical University of Vienna
Lead sponsor
Synapse - Research Institute Maastricht
Collaborator
