Platelet Concentrate: Liberal use (standard treatment)
Prothrombin Complex Concentrate: Liberal use (standard treatment)
Restricitve Use: Restrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Major Bleeding — 3 days bleeding complication within 3 days after the intervention
Trial sites (1)
Facility
City
Region
Status
General Hospital of the Medical University of Vienna
Vienna
Austria
Recruiting
More Medical University of Vienna trials in Austria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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