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ThrombelastographyVETILNONCT06635564

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

An observational study of Thrombelastography and Liver Transplant, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Viscoelastic testing
How many people
240 participants
Where
1 siteAustria
Study dates
1 Jul 2024to 5 May 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: 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

Who may be able to join

  • 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

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Medical University of Vienna

    Vienna, Austria, 1090

Other trials in Austria

About this study

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

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. Additionally, following the introduction of Apiro Diagnostics test kits as a potentially equivalent alternative to ClotPro, agreement between MultiClot and ClotPro was assessed in a subset of patients. 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.

Read the 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.

Being tested
Viscoelastic testing
Keywords
Viscoelastic testing, personalized bleeding management
Medical subject headings
Postpartum Hemorrhage, Hemostatic Disorders, Intracranial Hemorrhages

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Viscoelastic testingDiagnostic test

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

Study groups in NCT06635564
Study groupRoleWhat they receive
Patients with functional liver disease undergoing liver surgeryThis group consists of 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.
Receives: Diagnostic Test: Viscoelastic testing
neurosurgical patients undergoing intracranial proceduresThis group consists of patients who undergo elective neurosurgery e.g. tumor resection, aneurysm clipping or other intracranial procedures.
Receives: Diagnostic Test: Viscoelastic testing
pregnant women undergoing cesarean sectionThis group consists of pregnant women undergoing elective cesarean section.
Receives: Diagnostic Test: Viscoelastic testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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)

Secondary outcomes (11)
  1. 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

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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)

    Measured: 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)

  5. 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)

    Measured: 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)

  6. 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.

    Measured: 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)

  7. 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.

    Measured: 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)

  8. 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.

    Measured: 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)

  9. 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.

    Measured: 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

  10. 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.

    Measured: 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)

  11. Head-to-Head Comparison of Viscoelastic ClotPro assays with MultiClot assays

    In a subset of the overall study population, comprising ≥20 consecutively enrolled patients per surgical cohort, paired MultiClot (Apiro Diagnostics) and ClotPro measurements were obtained to assess agreement between corresponding viscoelastic parameters, with a focus on clot initiation and clot firmness.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2024
  2. Study start1 Jul 2024
  3. Primary completion5 Apr 2026
  4. Study completion5 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06635564
Sponsor's protocol ID
1622/2023
Acronym
VETILNO
Status last verified
May 2025
First submitted
27 Sep 2024
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: * Study Protocol * Statistical Analysis Plan (SAP) * Informed Consent Form (ICF) * Clinical Study Report (CSR) * Analytic Code

Questions about this trial

What is this clinical trial studying?

An observational study of Thrombelastography and Liver Transplant, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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