Coagulation in Cirrhosis
- Conditions
- Liver Cirrhosis
- Interventions
- Registration Number
- NCT05667805
- Lead Sponsor
- Medical University of Vienna
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liberal substitution of human prothrombin complex and/or platelet concentrates Platelet Concentrate If INR \< 1,5: 10 I.E. human prothrombin complex/kg bodyweigt/0,5 INR AND/OR If platelets \< 50 G/l: ((50 G/l - measured thrombocyte concentration G/l) x total blood volume) platelet concentrate Restrictive substitution of human prothrombin complex and/or thrombocytes Restricitve Use No substitution of blood products described in the Active Comparator group. Liberal substitution of human prothrombin complex and/or platelet concentrates Prothrombin Complex Concentrate If INR \< 1,5: 10 I.E. human prothrombin complex/kg bodyweigt/0,5 INR AND/OR If platelets \< 50 G/l: ((50 G/l - measured thrombocyte concentration G/l) x total blood volume) platelet concentrate
- Primary Outcome Measures
Name Time Method Major Bleeding 3 days bleeding complication within 3 days after the intervention
- Secondary Outcome Measures
Name Time Method bleeding complication 28 days bleeding complication within 28 days after the intervention
28 day overall mortality 28 days transfusion related complications 28 days 28 day bleeding related mortality 28 days thromboembolic events 28 days
Trial Locations
- Locations (1)
General Hospital of the Medical University of Vienna
🇦🇹Vienna, Austria