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

NCT06635564 | Recruiting

• 1 other identifier: 1622/2023
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Viscoelastic testing; personalized bleeding management

Outcome Measures

Primary Outcomes (1)

• Limits of agreement viscoelastic test parameters

  Calculate limits of agreement between the following corresponding viscoelastic test parameters: * EX-test- clotting time vs. EXTEM-clotting time vs. citrated rapid TEG r time * EX-test- maxium clot firmness vs. EXTEM-maximum clot firmness vs. citrated rapid TEG-maximum amplitude * FIB-test-clotting time vs. FIBTEM-clotting time vs. citrated functional fibrinogen r time * FIB-test-maxium clot firmness vs. FIBTEM-maxium clot firmness vs. citrated functional fibrinogen-maximal amplitude

  Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)

Secondary Outcomes (10)

• In depth hemostatic assessment: Viscoelastic tests (VET) & thrombin generation assay (with thrombmodulin)

  Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)

• In depth hemostatic assessment: Viscoelastic tests (VET) & standard laboratory coagulation tests (SLT)

  Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)

• In depth hemostatic assessment: Viscoelastic tests & plasmin generation (PG)

  Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)

• Patient cohort-specific reference ranges

  Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)

• Useability

  Baseline (immediately after induction of general anaesthesia / prior to regional anesthesia); end of the surgery / intervention (assessed up to 1h); Day 1: 1. postoperative day (assessed within 24h) ; Day 3: 3. postoperative day (assessed within 24)

Study Arms (3)

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.

Diagnostic Test: Viscoelastic testing

neurosurgical patients undergoing intracranial procedures

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

Diagnostic Test: Viscoelastic testing

pregnant women undergoing cesarean section

This group consists of pregnant women undergoing elective cesarean section.

Diagnostic Test: Viscoelastic testing

Interventions

Viscoelastic testing DIAGNOSTIC_TEST

viscoelasting testing refers to a global hemostatic assay,that quantifies the viscoelastic properties of citrated whole blood

Patients with functional liver disease undergoing liver surgery; neurosurgical patients undergoing intracranial procedures; pregnant women undergoing cesarean section

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be comprised of three groups: 1. 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. 2. Pregnant women undergoing elective cesarean section. 3. Patients undergoing elective intracranial neurosurgery

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Medical University of Vienna: lead
• Synapse - Research Institute Maastricht: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, Austria, 1090, Austria

RECRUITING

Biospecimen

Retention: NONE RETAINED

Blood

MeSH Terms

Conditions

Postpartum Hemorrhage; Hemostatic Disorders; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Johannes Gratz, PhD MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolaus Hofmann, MD

CONTACT

00436645379719; nikolaus.hofmann@meduniwien.ac.at

Carlo Martin, MD

CONTACT

00436801349429; carlo.martin@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 10, 2024
• Study Start: July 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

AU (1)