Coagulation in Cirrhosis (COUCH)

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Drug: Platelet Concentrate; Drug: Prothrombin Complex Concentrate; Other: Restricitve Use

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Armin Langauer, MD; Phone Number: +43 1 40400 41000; Email: armin.langauer@meduniwien.ac.at
• Study Contact Backup: Name: Kristina Nieding, MD; Phone Number: +43 1 40400 41000; Email: kristina.nieding@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • General Hospital of the Medical University of Vienna
    • Contact: David M Baron, MD
    • Principal Investigator: David M Baron, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Platelet Concentrate; Liberal use (standard treatment); Drug: Prothrombin Complex Concentrate; Liberal use (standard treatment); Other Names: PPSB
Experimental: Restrictive substitution of human prothrombin complex and/or thrombocytes; No substitution of blood products described in the Active Comparator group.	Other: Restricitve Use; Restrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Bleeding	bleeding complication within 3 days after the intervention	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bleeding complication	bleeding complication within 28 days after the intervention	28 days
thromboembolic events		28 days
transfusion related complications		28 days
28 day overall mortality		28 days
28 day bleeding related mortality		28 days

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): December 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Transfusion; Coagulation; Patient Blood Management; Platelet Concentrates
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis; Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: 1144/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No