Personalized ViscoElastic Testing-guided Bleeding Management In Liver Surgery, Neurosurgery and Obstetrics - a Prospective Comparison of the Novel ClotPro With ROTEM and TEG
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medical University of Vienna
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Limits of agreement viscoelastic test parameters
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Vulnerable patient cohorts
- •Patients undergoing elective liver surgery defined as one of the following invasive procedures:
- •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
- •Patients undergoing an elective intracranial neurosurgery.
- •Written informed consent
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Limits of agreement viscoelastic test parameters
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)
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
Secondary Outcomes
- In depth hemostatic assessment: Viscoelastic tests (VET) & thrombin generation assay (with thrombmodulin)(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)(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)(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(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(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(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(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(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(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(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))
Investigators
Johannes Gratz
Principal investigator
Medical University of Vienna