Coagulation in Cirrhosis

Last updated: January 10, 2025
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

4

Condition

Hyponatremia

Hepatic Fibrosis

Scar Tissue

Treatment

Prothrombin Complex Concentrate

Restricitve Use

Platelet Concentrate

Clinical Study ID

NCT05667805
1144/2022
  • Ages > 18
  • All Genders

Study 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

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

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 physicalexamination (e.g., petechia, ecchymosis, mucosal bleeding, hemorrhagic diathesiswithin the family, menorrhagia, prolonged bleeding after surgery)

Study Design

Total Participants: 400
Treatment Group(s): 3
Primary Treatment: Prothrombin Complex Concentrate
Phase: 4
Study Start date:
January 19, 2023
Estimated Completion Date:
March 01, 2027

Study 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.

Connect with a study center

  • General Hospital of the Medical University of Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

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