Coagulation in Cirrhosis

NCT ID: NCT05667805

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-19
• Study Completion Date: 2027-03-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Platelet Concentrate

Intervention Type: DRUG

Liberal use (standard treatment)

Prothrombin Complex Concentrate

Intervention Type: DRUG

Liberal use (standard treatment)

Restrictive substitution of human prothrombin complex and/or thrombocytes

No substitution of blood products described in the Active Comparator group.

Group Type: EXPERIMENTAL

Restricitve Use

Intervention Type: OTHER

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

Interventions

Platelet Concentrate

Liberal use (standard treatment)

Intervention Type: DRUG

Prothrombin Complex Concentrate

Liberal use (standard treatment)

Intervention Type: DRUG

Restricitve Use

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

Intervention Type: OTHER

Other Intervention Names

PPSB

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

David M Baron, MD, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

General Hospital of the Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Armin Langauer, MD

Role: CONTACT

armin.langauer@meduniwien.ac.at

+43 1 40400 41000

Kristina Nieding, MD

Role: CONTACT

kristina.nieding@meduniwien.ac.at

+43 1 40400 41000

Facility Contacts

David M Baron, MD

Role: primary

Other Identifiers

1144/2022

Identifier Type: -

Identifier Source: org_study_id