Coagulation in Cirrhosis
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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)
Locations
Other Locations
Austria
General Hospital of the Medical University of Vienna
RECRUITING
Vienna
Contact Information
Primary
Armin Langauer, MD
armin.langauer@meduniwien.ac.at
+43 1 40400 41000
Backup
Kristina Nieding, MD
kristina.nieding@meduniwien.ac.at
+43 1 40400 41000
Time Frame
Start Date: 2023-01-19
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 400
Treatments
Active_comparator: Liberal substitution of human prothrombin complex and/or platelet concentrates
If INR \< 1,5: 10 I.E. human prothrombin complex/kg bodyweigt/0,5 INR AND/OR If platelets \< 50 G/l: ((50 G/l - measured thrombocyte concentration G/l) x total blood volume) platelet concentrate
Experimental: Restrictive substitution of human prothrombin complex and/or thrombocytes
No substitution of blood products described in the Active Comparator group.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Vienna