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

NCT ID: NCT06635564

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-07-31

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.

Conditions

Thrombelastography; Liver Transplant; Postpartum Hemorrhage; Bleeding Disorder; Intracranial Hemorrhages

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with functional liver disease undergoing liver surgery

This 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.

Viscoelastic testing

Intervention Type: DIAGNOSTIC_TEST

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

neurosurgical patients undergoing intracranial procedures

This group consists of patients who undergo elective neurosurgery e.g. tumor resection, aneurysm clipping or other intracranial procedures.

Viscoelastic testing

Intervention Type: DIAGNOSTIC_TEST

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

pregnant women undergoing cesarean section

This group consists of pregnant women undergoing elective cesarean section.

Viscoelastic testing

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Viscoelastic testing

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Written informed consent

Exclusion Criteria

none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synapse - Research Institute Maastricht

UNKNOWN

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Johannes Gratz

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johannes Gratz, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, Austria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Nikolaus Hofmann, MD

Role: CONTACT

nikolaus.hofmann@meduniwien.ac.at

00436645379719

Carlo Martin, MD

Role: CONTACT

carlo.martin@meduniwien.ac.at

00436801349429

Facility Contacts

Christoph Dibiasi, MD

Role: primary

christoph.dibiasi@meduniwien.ac.at

0043 1 40400 41660

Other Identifiers

1622/2023

Identifier Type: -

Identifier Source: org_study_id