跳至主要内容
临床试验/NCT05789654
NCT05789654招募中不适用

Accuracy of PADUA PREDICTION SCORE in Thromboembolic Risk Stratification of Cirrhotic Patients Hospitalized in a Non-surgical Environment

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2020年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
132
试验地点
1
主要终点
predicting venous thromboembolic risk in liver cirrhosis

研究概览

简要总结

Primary objective: to evaluate the predictive role of Prediction Score on the risk of developing venous thromboembolism in patients with liver cirrhosis admitted to non-surgical wards.

Secondary objectives:

  • To estimate the prevalence and incidence of venous thromboembolism in patients with liver cirrhosis admitted to non-surgical wards
  • To calculate the prevalence in the same subset of patients of major bleeding (defined as bleeding resulting in the patient's death, a drop in hemoglobin > 2g/L, the need to transfuse > 2 units of packed red blood cells or bleeding into a critical organ/space including the intracranial, retroperitoneal, intraocular, adrenal, spinal, pericardial districts) related to the application or not of thromboprophylaxis measures (pharmacological and mechanical) Study design: The study is single center and it will be divided into two parts, a first retrospective part and a second prospective case control study.

Methods: adult patients with liver cirrhosis admitted in Internal Medicine and Gastroenterology Unit of Policlinico Agostino Gemelli will be enrolled in the prospective study. For the retrospective part of the study, data about cirrhotic patients hospitalized in non-surgical departments of Policlinico Agostino Gemelli will be collected. Exclusion criteria will be hospitalization in surgical wards or intensive care units, patients with active bleeding at the time of admission, patients hospitalized for liver transplantation, anticoagulant therapy at therapeutic dosage at the time of admission for indications other than liver cirrhosis (e.g. personal history of thromboembolic events, atrial fibrillation/flutter or mechanical heart valves), contraindications to anticoagulant prophylaxis (recent or ongoing bleeding, creatinine clearance assessed by EPI-CKD method < 15 ml/min, platelet count < 50 x 10^9/L), patients hospitalized as elective regimen to perform invasive procedures that contraindicate anticoagulant prophylaxis (e.g. liver biopsy, local treatment of liver neoplasms, ligation of oesophageal varices), double antiplatelet therapy, pregnancy

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

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

  • written informed consent
  • age more than 18 years old
  • diagnosis of liver cirrhosis
  • hospitalization in a medical department

排除标准

  • pregnancy
  • ongoing double anticoagulation or double antiplatelet therapy at the moment of hospitalization
  • controindications to anticoagulation therapy
  • hospitalization in surgical environnment

结局指标

主要结局

predicting venous thromboembolic risk in liver cirrhosis

时间窗: 12 months

evaluating Padua Prediction Score role in predicting venous thromboembolic risk in liver cirrhosis

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

Zocco Maria Assunta

Prof

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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