General Hospital of the Medical University of Vienna
Vienna, 1090, Austria
Location status: Recruiting
Location contact
David M Baron, MD
CONTACT
David M Baron, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05667805
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Vienna, 1090, Austria
Location status: Recruiting
David M Baron, MD
CONTACT
David M Baron, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Exclusion criteria
Liberal use (standard treatment)
Liberal use (standard treatment)
Other names: PPSB
Restrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution.
Time frame: 3 days
bleeding complication within 3 days after the intervention
Time frame: 28 days
bleeding complication within 28 days after the intervention
Time frame: 28 days
Time frame: 28 days
Time frame: 28 days
Time frame: 28 days
Contact information is provided by the study sponsor or research team.
Armin Langauer, MD
CONTACT
Kristina Nieding, MD
CONTACT
Medical University of Vienna
Other
Acronym: COUCH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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