跳至主要内容
临床试验/NCT02813538
NCT02813538已完成不适用

Hypercoagulability and Liver Function After Major Liver Resection

Hospital General Universitario Gregorio Marañon1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年2月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Establish a relationship between ICG and MCF

研究概览

简要总结

The aim of this study is to evaluate early clotting disorders through thromboelastogram and anticoagulant proteins levels (maybe also endothelial markers) and liver function by indocyanine green clearance after major liver resection and search for a potential relationship between them.

详细描述

We are prospectively recording data from patients undergoing major liver resection. We obtain a full procoagulant and anticoagulant profile preoperatively and, at first, second and sixth day after surgery. We also measure indocyanine green (ICG) clearance preoperatively and in the first two postoperative days. We are also recording clinical data, focusing on medical and surgical complications. We aim to establish the potential value of ICG clearance and or coagulation profile to predict clinical complications

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Patients undergoing major liver surgery defined as resection of 3 or more hepatic segments

排除标准

  • Indocyanin green allergy
  • Thyrotoxicosis
  • Thrombophilia
  • Lupus anticoagulant
  • Coagulation factor deficiency
  • Venous thromboembolism in the last 3 years
  • Pulmonary thromboembolism in the last 3 years

研究组 & 干预措施

IGC and thromboelastometry

Patients that have hyper, normo o hypcoagulability measured by tromboelastometry and anticoagulant proteins levels early after major liver resection and clinical evolution and patients with liver funcion impairment or without it, measured by indocyanine green clearance early after surgery and clinical evolution

干预措施: Indocyanine green clearance (Drug)

IGC and thromboelastometry

Patients that have hyper, normo o hypcoagulability measured by tromboelastometry and anticoagulant proteins levels early after major liver resection and clinical evolution and patients with liver funcion impairment or without it, measured by indocyanine green clearance early after surgery and clinical evolution

干预措施: Thromboelastometry (Other)

结局指标

主要结局

Establish a relationship between ICG and MCF

时间窗: 1 week

We aim to find a potential association between ICG and MCF measured by thromboelastometry in the first week after surgery

Establish a relationship between pro and anticoagulant proteins levels and endothelial markers

时间窗: 1 week

We aim to find a potential association between procoagulant factor levels, protein C,S and ATIII with thrombomodulin, heparan sulfate and syndecan-1 in the first week after surgery

次要结局

  • Study blood coagulation disorders after major liver surgery resection(2 years)
  • Study liver function after major liver surgery(2 years)

研究者

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Duque González

MD, PhD

Hospital General Universitario Gregorio Marañon

研究点 (1)

Loading locations...

相似试验