Coagulation in Cirrhosis

Recruiting now · Phase 4

Conditions studied: Liver Cirrhosis

In brief

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.

Key facts

Study ID

NCT05667805

Run by

Medical University of Vienna

People needed

400

Starts

2023-01-19

Expected to finish

2027-03-01

Last updated by the study team

2025-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• General Hospital of the Medical University of Vienna — Vienna, Austria (enrolling)

Full record on ClinicalTrials.gov

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