Coagulation in Cirrhosis

• Status: Not yet recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Out of fear of bleeding, liver cirrhosis patients are often treated prophylactically with blood and coagulation products before minor interventions. The COUCH study will examine whether these patients benefit from a restrictive administration of coagulation products.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Thrombin

Criteria

Inclusion Criteria:

Patients at the University Hospital of Vienna with diagnosed liver cirrhosis and deranged coagulation parameters (INR >1,5 AND/ OR platelet count <50 G/L) who are scheduled for one of the following elective invasive interventions of the liver

• Biopsy or puncture

• Microwave ablation (MWA) or radiofrequency ablation (RFA)

• Transjugular intrahepatic portosystemic shunt (TIPS)

• Percutaneous transhepatic cholangiography drain (PTCD)

Exclusion Criteria:

• Missing informed consent or inability to consent

• Age < 18 years

• Pregnancy or breastfeeding

• Manifest ascites

• Chronic kidney injury stage G4 or G5, KDIGO

• Uninterrupted anticoagulant therapy, except for acetylsalicylic acid (ASA)

• History of bleeding or clinical signs of a hemorrhagic diathesis in the physical examination (e.g., petechia, ecchymosis, mucosal bleeding, hemorrhagic diathesis within the family, menorrhagia, prolonged bleeding after surgery)