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NCT Number: NCT05667805

Coagulation in Cirrhosis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Hospital of the Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Location contact

David M Baron, MD

CONTACT

David M Baron, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Platelet Concentrate

Drug

Liberal use (standard treatment)

Prothrombin Complex Concentrate

Drug

Liberal use (standard treatment)

Other names: PPSB

Restricitve Use

Other

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

Primary outcomes

  1. Major Bleeding

    Time frame: 3 days

    bleeding complication within 3 days after the intervention

Secondary outcomes

  1. bleeding complication

    Time frame: 28 days

    bleeding complication within 28 days after the intervention

  2. thromboembolic events

    Time frame: 28 days

  3. transfusion related complications

    Time frame: 28 days

  4. 28 day overall mortality

    Time frame: 28 days

  5. 28 day bleeding related mortality

    Time frame: 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Armin Langauer, MD

CONTACT

[email protected]

+43 1 40400 41000

Kristina Nieding, MD

CONTACT

[email protected]

+43 1 40400 41000

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Acronym: COUCH

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 29, 2022
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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