RecruitingPhase 4NCT05667805

Coagulation in Cirrhosis

Sponsor

Medical University of Vienna

Enrollment

400 participants

Start Date

Jan 19, 2023

Study Type

INTERVENTIONAL

Conditions

Liver Cirrhosis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria7

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)