Coagulation in Cirrhosis

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Major Bleeding [Срок оценки: 3 days]

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Австрия · 1 центр

• General Hospital of the Medical University of Vienna — Vienna

Идентификаторы

NCT: NCT05667805 · 1144/2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗