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临床试验/NCT04076605
NCT04076605已完成不适用

Bleeding in Hospitalized Patients With Liver Disease Undergoing Invasive Procedures

University of Virginia1 个研究点 分布在 1 个国家目标入组 1,182 人开始时间: 2019年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,182
试验地点
1
主要终点
Prevalence of procedural-related bleeding events in patients with cirrhosis

研究概览

简要总结

Patients with cirrhosis are frequently hospitalized and often undergo procedures. Knowledge surrounding bleeding risk is sparse and practice patterns vary across centers in regards to bleeding prophylaxis. The goal of this study to is to obtain more knowledge regarding risk factors for procedural related bleeding in patients with cirrhosis and to develop a predictive model to risk stratify patients before undergoing procedures. Through collaboration from centers across the world this study should provide information on prevalence of bleeding and variation in practice patterns for prophylaxis.

详细描述

Hospitalized patients with cirrhosis who undergo 1 or more non-surgical procedure will be enrolled. The investigators will collect multiple clinical characteristics from the medical record and follow the patients prospectively over the hospitalization and/or until 28 days to determine if clinical events have occurred including bleeding, thrombosis, re-hospitalization and death. Characteristics of the hospitalization will be recorded including presence of acute decompensation and acute on chronic liver failure (ACLF). Procedure type will be recorded including coagulation laboratory data before and after each procedure. All bleeding events will be recorded and characteristics surrounding each bleed will be recorded. Bleeding will be defined according to International Thrombosis and Haemostasis (ISTH) definitions of major bleed and clinically relevant non-major bleed. REDCap (https://www.project-redcap.org) will be used to collect and centralize data maintained at the University of Virginia. Characteristics of each hospitalization will be recorded accordingly and patients will be followed for 28 days for outcome and mortality information. Each participating center will obtain local Institutional Review Board (IRB) approval to participate and enter data directly into REDCap. After center IRB approval is obtained, centers will consecutively enrolling patients on a rolling basis. Data will be collected from enrollment until death, transplant, discharge and/or 28 days on each individual enrolled.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Adult patients with cirrhosis admitted to a hospital ward or ICU for greater than 24 hours.
  • Patient must undergo 1 or more invasive non-surgical procedures at admission or during the hospitalization.

排除标准

  • Age < 18 years old
  • Unable to provide consent
  • Previously enrolled in this study

结局指标

主要结局

Prevalence of procedural-related bleeding events in patients with cirrhosis

时间窗: Each patient enrolled will be followed for 28 days

During each hospitalization every procedure will be recorded and details surrounding each bleeding event related to a procedure will be recorded.

次要结局

未报告次要终点

研究者

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

Nicolas Intagliata, MD

Associate Professor, Gastroenterology

University of Virginia

研究点 (1)

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