NCT05667805

Coagulation in Cirrhosis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with cirrhosis commonly have deranged coagulation parameters, in particular thrombocytopenia and/or an increased INR. However, these laboratory findings do not necessarily correlate with an increased tendency of bleeding. In fact, the reduced synthesis of both pro- and anticoagulant factors often equates to a new equilibrium in the coagulation system. Nevertheless, out of fear of bleeding, liver cirrhosis patients with deviated laboratory coagulation parameters are often aggressively treated with coagulation products (such as platelet concentrates and prothrombin complex concentrate (PCC)) before minor interventions and punctures. Since these products can also have procoagulant side effects, we will investigate whether patients with liver cirrhosis without a history of bleeding or clinical bleeding signs benefit from a restrictive substitution regime. The study will be carried out monocentrically at the General Hospital of Vienna, and will include 400 patients divided into two groups (liberal vs. restrictive substitution of thrombocytes and/or PCC) over an est. period of 4 years.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	Platelet Concentrate	Liberal use (standard treatment)
DRUG	Prothrombin Complex Concentrate	Liberal use (standard treatment)
OTHER	Restricitve Use	Restrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution.

Timeline

• Start date: 2023-01-19
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2022-12-29
• Last updated: 2025-01-14

Locations

1 site across 1 country: Austria