Skip to content

Coagulation in Cirrhosis

Coagulation in Cirrhosis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05667805
Acronym
COUCH
Enrollment
400
Registered
2022-12-29
Start date
2023-01-19
Completion date
2027-03-01
Last updated
2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

Keywords

Patient Blood Management, Platelet Concentrates, Transfusion, Coagulation

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.

Interventions

Liberal use (standard treatment)

Liberal use (standard treatment)

OTHERRestricitve Use

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

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

interventional radiologists

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Major Bleeding3 daysbleeding complication within 3 days after the intervention

Secondary

MeasureTime frameDescription
bleeding complication28 daysbleeding complication within 28 days after the intervention
thromboembolic events28 days
transfusion related complications28 days
28 day overall mortality28 days
28 day bleeding related mortality28 days

Countries

Austria

Contacts

Primary ContactArmin Langauer, MD
armin.langauer@meduniwien.ac.at+43 1 40400 41000
Backup ContactKristina Nieding, MD
kristina.nieding@meduniwien.ac.at+43 1 40400 41000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026