NCT06635564

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Viscoelastic testing	viscoelasting testing refers to a global hemostatic assay,that quantifies the viscoelastic properties of citrated whole blood

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-04-30
• Completion: 2026-07-31
• First posted: 2024-10-10
• Last updated: 2025-05-23

Locations

1 site across 1 country: Austria