USE OF THROMBOELASTOGRAPHY TO GUIDE BLOOD PRODUCTS REPLACEMENT IN DECOMPENSATED CIRRHOTIC PATIENTS UNDERGOING INVASIVE PROCEDURES
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Comparison in the amount of blood products transfused between the groups
研究概览
简要总结
Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests (namely INR and PLTs count) are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Thromboelastography (TEG) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study was to evaluate the efficacy of TEG as a guide for blood products transfusion in cirrhotic patients undergoing invasive procedures.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or imaging-proven liver cirrhosis of any etiology
- •INR>1.8 and/or PLTs count <50x103/μl
排除标准
- •Ongoing bleeding
- •Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel
- •Ongoing antiplatelet or anticoagulant therapy or stopped less than 7 days before evaluation for the study
- •Presence of sepsis according to ACP-SCCP criteria
- •Hemodialysis performed within 7 days
结局指标
主要结局
Comparison in the amount of blood products transfused between the groups
时间窗: 48 hours from admission
Comparison of the number of patients receiving blood products (FFPor PLTs or both), and the amount of blood products between the study groups
次要结局
- Survival(90 days patient survival)
- Procedure-related complications(during hospitalization (mean 4 weeks))
- Post-procedure bleeding(48 hours from admission)
- Transfusion related side effects(48 hours from admission)
- Comparison between blood products costs between groups(48 hours from admission)
研究者
Lesley De Pietri
Consultant Anaesthestetist
University of Modena and Reggio Emilia