Coagulation in Cirrhosis

Liver Cirrhosis Clinical Trial

— COUCH  

Official title:

Coagulation in Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05667805
• Other study ID #: 1144/2022
• Status: Recruiting
• Phase: Phase 4
• Start date: January 19, 2023
• Est. completion date: March 1, 2027

Study information

• Verified date: March 2023
• Source: Medical University of Vienna
• Contact: Armin Langauer, MD
• Phone: +43 1 40400 41000
• Email: armin.langauer[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• Platelet Concentrate
Liberal use (standard treatment)
• Prothrombin Complex Concentrate
Liberal use (standard treatment)

Other:
• Restricitve Use
Restrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution.

Locations

Country	Name	City	State
Austria	General Hospital of the Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Bleeding	bleeding complication within 3 days after the intervention	3 days
Secondary	bleeding complication	bleeding complication within 28 days after the intervention	28 days
Secondary	thromboembolic events		28 days
Secondary	transfusion related complications		28 days
Secondary	28 day overall mortality		28 days
Secondary	28 day bleeding related mortality		28 days