| NCT ID | NCT05667805 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medical University of Vienna |
| Condition | Liver Cirrhosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-01-19 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2023-01-19 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05667805 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05667805 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05667805 currently recruiting?
Yes, NCT05667805 is actively recruiting participants. Contact the research team at armin.langauer@meduniwien.ac.at for enrollment information.
Where is the NCT05667805 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT05667805 clinical trial?
NCT05667805 is sponsored by Medical University of Vienna. The trial plans to enroll 400 participants.