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

What this Trial Is About

Researchers are evaluating the agreement of the ClotPro 6.0 viscoelastic analyzer with ROTEM delta and TEG 6s devices in three different patient groups: those with liver disease undergoing liver surgery, pregnant women having elective cesarean sections, and patients undergoing elective intracranial neurosurgery. This study also explores how these viscoelastic tests compare with other coagulation assessments like standard laboratory tests, thrombin generation, and plasmin generation tests. The results of these tests will not affect patient diagnosis or treatment during the study. Participants are grouped based on their medical procedures: liver surgery patients undergoing various types of liver resections or transplants, neurosurgery patients having procedures such as tumor removal or aneurysm clipping, and pregnant women scheduled for cesarean delivery. The study measures clotting parameters at multiple time points: baseline (just after anesthesia induction or before regional anesthesia), immediately after surgery (up to 1 hour), and on postoperative days 1 and 3. Participants will undergo blood sampling and coagulation testing at these specified times to assess clotting function using the different devices and tests. Researchers will compare the timing and results of these tests to understand how quickly accurate results become available and how they relate to clinical outcomes like bleeding or clotting events. The study also investigates differences in clotting by biological sex and aims to define reference ranges specific to each patient group. The total study duration varies according to the surgery and follow-up days, with safety and outcome monitoring included.

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