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

Last updated: October 9, 2024
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blood Clots

Thrombocytopenic

Hemorrhage

Treatment

Viscoelastic testing

Clinical Study ID

NCT06635564
1622/2023
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Vulnerable patient cohorts

  • Patients undergoing elective liver surgery defined as one of the followinginvasive procedures:

  • Liver resection (anatomic or non-anatomic segmental resection, right orleft hepatectomy, right or left extended hepatectomy),

  • Orthotopic liver transplantation,

  • Pregnant women undergoing an elective caesarean section, and

  • Patients undergoing an elective intracranial neurosurgery.

  1. Written informed consent

Exclusion

Exclusion Criteria:

none

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: Viscoelastic testing
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
May 01, 2026

Study 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.

Connect with a study center

  • Medical University of Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

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