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NCT05667805
Coagulation in Cirrhosis
Conditions: Liver Cirrhosis
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 400
Sponsor: Medical University of Vienna
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 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 liverBiopsy or punctureMicrowave ablation (MWA) or radiofrequency ablation (RFA)Transjugular intrahepatic portosystemic shunt (TIPS)Percutaneous transhepatic cholangiography drain (PTCD)Exclusion Criteria:Missing informed consent or inability to consentAge < 18 yearsPregnancy or breastfeedingManifest ascitesChronic kidney injury stage G4 or G5, KDIGOUninterrupted 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)
Source: ClinicalTrials.gov (NCT05667805). StuddyBuddy aggregates publicly available trial information.