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.
The primary research question is therefore to compare various parameters of standard ClotPro measurements with corresponding ROTEM delta and TEG 6s parameters. Additionally, this study aims to close the following clinically important knowledge gaps: Do VET results mirror measurements obtained by more holistic, in-depth analyses of the hemostatic system that are currently not available in clinical practice, such as TGA-TM and PG? Which of the three investigated VET devices offers the most rapid availability of diagnostic results? Do VET results have a predictive ability for the occurrence of perioperative bleeding and/or thromboembolic events? Do VET results depict sex-specific differences in perioperative coagulation management? Furthermore, by including a large number of patients from three distinct patient cohorts, this study intends to examine whether cohort-specific reference ranges need to be established for ClotPro. Thereby, this study aims to provide the foundation for an evidence-based ClotPro-guided perioperative coagulation management algorithm, which could upscale current opportunities of personalizing perioperative coagulation management.
Study Type
OBSERVATIONAL
Enrollment
240
viscoelasting testing refers to a global hemostatic assay,that quantifies the viscoelastic properties of citrated whole blood
Medical University of Vienna
Vienna, Austria, Austria
RECRUITINGLimits 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
Time frame: Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)
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
Time frame: Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)
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.
Time frame: Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)
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.
Time frame: Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)
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)
Time frame: Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)
Useability
To evaluate the clinical useability of the three viscoelastic test devices by assessing differences in time from starting sample processing until each device reports the following parameters: clot formation (CT / R) and clot firmness (MCF / MA)
Time frame: Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)
Predictability of clinical outcome: blood products
To assess wether baseline clot formation (CT / R) and clot firmness (MCF / MA) measurements for the extrinsic VET coagulation assays (EX-test, EXTEM, and CRT; FIB-test, FIBTEM, and CFF) correlate with the amount of blood product consumption.
Time frame: Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)
Predictability of clinical outcomes: hemorrhage
To examine whether end of surgery clot formation (CT / R) and clot firmness (MCF / MA) measurements derived by viscoelastic test assays (EX-test, EXTEM, and CRT; FIB-test, FIBTEM, and CFF) correlate with hemorrhage defined by cCT imaging in patients undergoing intracranial neurosurgery.
Time frame: Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)
Predictability of clinical outcomes: ocurrence of BIMS (Bleeding Independently associated with Mortality after noncardiac Surgery) or need for surgical bleeding control
To examine wether end of surgery clot formation (CT / R) and clot firmness (MCF / MA) measurements for the viscoelastic test assays (EX-test, EXTEM, and CRT; FIB-test, FIBTEM, and CFF) correlate with the occurrence of i) BIMS, ii) the need for interventional radiologic procedures to stop bleeding within the surgical site, or iii) the need for revision in the operating room within the first 30 postoperative days.
Time frame: Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)
Predictability of clinical outcomes: thromboembolism
To examine whether a combination of baseline and end of surgery clot formation (CT / R) and clot firmness (MCF / MA) measurements for the viscelastic test assays (EX-test, EXTEM, and CRT; FIB-test, FIBTEM, and CFF) correlate with the occurrence of i) DVT (deep venous thrombosis), ii) PE (pulmonary embolism), ii) PVT (portal vein thrombosis) within the first 30 postoperative days.
Time frame: Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24) Edit
Coagulational differences based on biological sex
In this analysis, differences in the coagulational profile as assessed by viscoelastic tests, standard laboratory coagulation tests, thrombin generation assays (with thrombomodulin) and plasmin generation measurements will be compared between subjects of female or male sex.
Time frame: Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)
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