Study of Restricting Blood Clotting Treatments in Adults with Liver Cirrhosis Undergoing Elective Liver Procedures

What this Trial Is About

Researchers are evaluating how to best manage blood clotting treatments in patients with liver cirrhosis who often show abnormal clotting test results. These patients are usually given blood products before minor procedures out of concern for bleeding, even though their lab tests may not directly reflect their bleeding risk. This study aims to see if a more restrictive use of clotting products benefits those without a history or signs of bleeding. The trial compares two approaches a liberal use of blood clotting products like platelet concentrates and prothrombin complex concentrate PCC versus a restrictive approach where these products are given only when certain clinical thresholds are met. Patients with specific abnormal clotting tests scheduled for elective liver-related procedures will be assigned to either group. The study will enroll 400 patients and follow them over about four years at a single hospital. Participants will undergo their scheduled liver procedures while researchers monitor for bleeding events and other complications for up to 28 days after treatment. The main outcome is the occurrence of major bleeding within three days. Other outcomes include bleeding complications, clot-related events, transfusion reactions, and mortality over 28 days. The study includes regular assessments to track these events and ensure patient safety throughout the follow-up period.

Coagulation in Cirrhosis