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临床试验/NCT05667805
NCT05667805招募中4 期

Coagulation in Cirrhosis

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年1月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
400
试验地点
1
主要终点
Major Bleeding

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

interventional radiologists

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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)

研究组 & 干预措施

Liberal substitution of human prothrombin complex and/or platelet concentrates

Active Comparator

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

干预措施: Platelet Concentrate (Drug)

Liberal substitution of human prothrombin complex and/or platelet concentrates

Active Comparator

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

干预措施: Prothrombin Complex Concentrate (Drug)

Restrictive substitution of human prothrombin complex and/or thrombocytes

Experimental

No substitution of blood products described in the Active Comparator group.

干预措施: Restricitve Use (Other)

结局指标

主要结局

Major Bleeding

时间窗: 3 days

bleeding complication within 3 days after the intervention

次要结局

  • bleeding complication(28 days)
  • 28 day overall mortality(28 days)
  • transfusion related complications(28 days)
  • 28 day bleeding related mortality(28 days)
  • thromboembolic events(28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David M Baron, MD, PhD

Associate Professor

Medical University of Vienna

研究点 (1)

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