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NCT Number: NCT06635564

Personalized ViscoElastic Testing-guided Bleeding Management In Liver Surgery, Neurosurgery and Obstetrics

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.

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Key information

Conditions

Thrombelastography Bleeding Disorder Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Intracranial Hemorrhages Liver Transplant Nervous System Diseases Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, Austria, 1090

About 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

none

Treatment and study plan

Viscoelastic testing

Diagnostic Test

viscoelasting testing refers to a global hemostatic assay,that quantifies the viscoelastic properties of citrated whole blood

Primary outcomes

  1. 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

  1. In depth hemostatic assessment: Viscoelastic tests (VET) & thrombin generation assay (with thrombmodulin)

    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)

    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

  2. In depth hemostatic assessment: Viscoelastic tests (VET) & standard laboratory coagulation tests (SLT)

    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)

    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.

  3. In depth hemostatic assessment: Viscoelastic tests & plasmin generation (PG)

    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)

    Correlation between the viscoelastic test parameters TPA-lysis time and TPA-maximal lysis with the endogenous plasmin potential derived by plasmin generation measurements.

  4. Patient cohort-specific reference ranges

    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)

    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)

  5. Useability

    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)

    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)

  6. Predictability of clinical outcome: blood products

    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)

    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.

  7. Predictability of clinical outcomes: hemorrhage

    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)

    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.

  8. Predictability of clinical outcomes: ocurrence of BIMS (Bleeding Independently associated with Mortality after noncardiac Surgery) or need for surgical bleeding control

    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)

    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.

  9. Predictability of clinical outcomes: thromboembolism

    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

    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.

  10. Coagulational differences based on biological 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)

    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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Synapse - Research Institute Maastricht

Registry information

Official study title

Personalized ViscoElastic Testing-guided Bleeding Management In Liver Surgery, Neurosurgery and Obstetrics - a Prospective Comparison of the Novel ClotPro With ROTEM and TEG

Acronym: VETILNO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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