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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
Liberal use (standard treatment)
Liberal use (standard treatment)
Restrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution.
General Hospital of the Medical University of Vienna
Vienna, Austria
RECRUITINGMajor Bleeding
bleeding complication within 3 days after the intervention
Time frame: 3 days
bleeding complication
bleeding complication within 28 days after the intervention
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
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