Accuracy of PADUA PREDICTION SCORE in Thromboembolic Risk Stratification of Cirrhotic Patients Hospitalized in a Non-surgical Environment
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
- 否
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
Zocco Maria Assunta
Prof
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
