Coagulation in Cirrhosis

Overview

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

• Drug Platelet Concentrate
  Liberal use (standard treatment)
• Drug Prothrombin Complex Concentrate
  Liberal use (standard treatment)
• Other Restricitve Use
  Restrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution.

Primary outcome measures

• Major Bleeding [Time frame: 3 days]

Secondary outcome measures (5)

• bleeding complication [Time frame: 28 days]
• thromboembolic events [Time frame: 28 days]
• transfusion related complications [Time frame: 28 days]
• 28 day overall mortality [Time frame: 28 days]
• 28 day bleeding related mortality [Time frame: 28 days]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Austria · 1 center

• General Hospital of the Medical University of Vienna — Vienna

Identifiers

NCT: NCT05667805 · 1144/2022

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗