ClinicalTrialsFinder
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)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPlatelet Concentrate

Liberal use (standard treatment)

DRUGProthrombin Complex Concentrate

Liberal use (standard treatment)

OTHERRestricitve Use

Restrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution.

Locations(1)

General Hospital of the Medical University of Vienna

Vienna, Austria

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05667805

Related Trials

A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)

NCT0732552627 locations

Comparison of Underdilated Versus Standard TIPS in Preventing Variceal Rebleeding in Patients With Cirrhosis

NCT072533891 location

Austrian PBC Registry

NCT0759866911 locations

Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe

NCT075858902 locations

The Diagnostic Value of Subharmonic Imaging Technology Combined With Liver Stiffness and Platelet Count for High-risk Esophageal and Gastric Varices in Patients With Liver Cirrhosis

NCT071518851 location