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

Medical University of Vienna

Status: Enrolling

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

Treatments: Diagnostic Test: Viscoelastic testing

Study type: Observational

Funder types: Other

Identifiers

NCT06635564

1622/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

240 participants in 3 patient groups

Patients with functional liver disease undergoing liver surgery

Description:

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.

Treatment:

Diagnostic Test: Viscoelastic testing

neurosurgical patients undergoing intracranial procedures

Description:

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

Treatment:

Diagnostic Test: Viscoelastic testing

pregnant women undergoing cesarean section

Description:

This group consists of pregnant women undergoing elective cesarean section.

Treatment:

Diagnostic Test: Viscoelastic testing