What this Trial Is About

Researchers are evaluating whether a restrictive use of coagulation products benefits patients with liver cirrhosis who have abnormal blood clotting test results but no history or signs of bleeding. Liver cirrhosis patients often have low platelet counts or increased INR, but these lab findings do not always mean they are more likely to bleed. Typically, these patients receive preventive treatment with platelet concentrates or prothrombin complex concentrate before minor liver procedures, but this study questions if less aggressive treatment might be better. This phase 4 study will take place at the General Hospital of Vienna and plans to enroll 400 patients over about 4 years. Participants will be divided into two groups: one receiving the standard liberal use of platelet concentrates and prothrombin complex concentrate, and the other receiving a restrictive use where these products are given only if needed and no preventive substitution is done. Eligible patients will be those scheduled for elective invasive liver procedures like biopsy, microwave or radiofrequency ablation, transjugular intrahepatic portosystemic shunt (TIPS), or percutaneous transhepatic cholangiography drain (PTCD). During the study, researchers will monitor participants for major bleeding events within 3 days following treatment. Other assessments include coagulation parameters and clinical signs of bleeding. The study aims to understand the safety and outcomes of a restrictive treatment strategy compared to the standard approach. Participants' health will be carefully followed during and after their procedures to evaluate the effects of the treatments.

Coagulation in Cirrhosis