跳至主要内容
临床试验/NCT04165538
NCT04165538Unknown不适用

Safety and Effectiveness of Clopidogrel Withdrawal Time Guided by Thromboelastography in Elderly Patients With Hip Fracture

Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 140 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
140
主要终点
Estimated red blood cell loss

研究概览

简要总结

In the elderly patients with hip fracture, some often take antiplatelet drugs such as clopidogrel due to the ischemic cardiovascular or cerebrovascular diseases. In traditional practice, these patients often need to stop medication for 5-7 days before surgery. But on the other hand, delayed surgery will lead to a significant increase in fracture related complications. Therefore, the appropriate time for drug withdrawal is particularly important in this population.

Thromboelastography is a monitoring method that can accurately judge the anticoagulation status of patients. We hope to use thromboelastography to guide the time of drug withdrawal, shorten the time of drug withdrawal as much as possible, and reduce the incidence of fracture related complications without increasing the risk of massive hemorrhage.

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 (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • hip fracture and operation
  • taking clopidogrel for more than one week before injury, with or without taking aspirin at the same time

排除标准

  • high energy injury (such as traffic accident, falling from height), bilateral hip fracture, multiple fractures or injuries, pathological fracture
  • malignant tumor patients
  • hormone users
  • patients with recent active bleeding or bleeding ulcer
  • primary or secondary coagulation dysfunction or depression caused by other reasons than taking antiplatelet drugs (for example, taking warfarin)
  • patients with other acute or unstable diseases requiring delayed surgery (acute heart failure, myocardial infarction, cerebral infarction, cerebral hemorrhage, severe pulmonary infection, deep vein thrombosis or pulmonary embolism, etc.)

结局指标

主要结局

Estimated red blood cell loss

时间窗: From admission when the first blood routine will be obtained to discharge when the last blood routine will be obtained, up to postoperative day 7.

The amount of red blood cell loss estimated by blood routine changes

次要结局

  • Blood transfusion(From admission when the first blood routine will be obtained to discharge when the last blood routine will be obtained, up to postoperative day 7.)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

相似试验