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Completed
NCT06635564
Personalized ViscoElastic Testing-guided Bleeding Management In Liver Surgery, Neurosurgery and Obstetrics
Conditions: Thrombelastography, Liver Transplant, Postpartum Hemorrhage, Bleeding Disorder, Intracranial Hemorrhages
Sex: All
Ages: 18 Years – N/A
Enrollment: 240
Sponsor: Medical University of Vienna
Location: Medical University of Vienna Vienna Austria
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. Additionally, following the introduction of Apiro Diagnostics test kits as a potentially equivalent alternative to ClotPro, agreement between MultiClot and ClotPro was assessed in a subset of patients. 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 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
Source: ClinicalTrials.gov (NCT06635564). StuddyBuddy aggregates publicly available trial information.