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
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Contact Information
Primary
Nikolaus Hofmann, MD
nikolaus.hofmann@meduniwien.ac.at
00436645379719
Backup
Carlo Martin, MD
carlo.martin@meduniwien.ac.at
00436801349429
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 240
Treatments
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.
neurosurgical patients undergoing intracranial procedures
This group consists of patients who undergo elective neurosurgery e.g. tumor resection, aneurysm clipping or other intracranial procedures.
pregnant women undergoing cesarean section
This group consists of pregnant women undergoing elective cesarean section.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Vienna
Collaborators: Synapse - Research Institute Maastricht

This content was sourced from clinicaltrials.gov