Actively Recruiting
Coagulation in Cirrhosis: Comparing Liberal and Restrictive Use of Blood Clotting Products Before Liver Procedures
Led by Medical University of Vienna · Updated on 2025-01-14
400
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Coagulation in Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with diagnosed liver cirrhosis and abnormal coagulation parameters (INR >1.5 and/or platelet count <50 G/L)
- Scheduled for elective invasive liver interventions such as biopsy, puncture, microwave or radiofrequency ablation, TIPS, or PTCD
- Age 18 years or older
- Ability to provide informed consent
You will not qualify if you...
- Missing informed consent or inability to consent
- Age under 18 years
- Pregnancy or breastfeeding
- Manifest ascites
- Chronic kidney injury stage G4 or G5 according to KDIGO
- Ongoing anticoagulant therapy except acetylsalicylic acid (ASA)
- History of bleeding or clinical signs of bleeding disorder such as petechia, ecchymosis, mucosal bleeding, family history of bleeding, menorrhagia, or prolonged bleeding after surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 days around the liver procedure
Participants receive either liberal or restrictive substitution of blood clotting products before elective invasive liver interventions.
1 treatment visit corresponding with the liver procedure
Duration - 28 days after treatment
Participants are monitored for bleeding complications, thromboembolic events, transfusion related complications, and mortality.
Follow-up visits as needed up to 28 days
Trial Site Locations
Total: 1 location
1
General Hospital of the Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
A
Armin Langauer, MD
K
Kristina Nieding, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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