Clinical trial NCT05667805: Coagulation in Cirrhosis
Official title: Coagulation in Cirrhosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Liver Cirrhosis
Keywords: Patient Blood Management
Platelet Concentrates
Transfusion
Coagulation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Major Bleeding
timeFrame: 3 days
Secondary outcomes:
measure: bleeding complication
timeFrame: 28 days
measure: thromboembolic events
timeFrame: 28 days
measure: transfusion related complications
timeFrame: 28 days
measure: 28 day overall mortality
timeFrame: 28 days
measure: 28 day bleeding related mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: General Hospital of the Medical University of Vienna
Study officials:
References: