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临床试验/NCT04216394
NCT04216394已完成不适用

Anticoagulation in Emergency General Surgery: Who Bleeds More? The ACES Trial

Methodist Health System1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
1
主要终点
Rate of operative

研究概览

简要总结

While DOACs are increasing in use in the EGS patient population, the risk of bleeding and the reversal of these agents to reduce hemorrhage is still evolving. Given the paucity of data regarding the impact of DOACs in this patient population, it becomes empiric to identify bleeding patterns and outcomes in the EGS population taking DOACs. We hypothesize that patients taking a DOAC will have a higher bleeding incidence and need for an unplanned intervention secondary to hemorrhage in EGS patients undergoing an urgent or emergent operation when compared to patients taking warfarin and antiplatelets.

详细描述

Emergency general surgery (EGS) represents illnesses of diverse pathology with urgent/emergent treatment needs being the common denominator.A characteristic feature of EGS is its limitation in patient preparation. It is difficult and often impossible to eliminate certain patient dependent factors to reduce the operative risk. It has been reported that the annual case rate in the EGS population is (1,290 per 100,000) higher than the sum of all cancer diagnoses. The EGS burden is substantial and continues to increase. The elderly patient population represents 48% of the overall EGS population. With the increase in the prevalence of atherosclerotic disease in the elderly there has been an increase in the use of antiplatelets and anticoagulants.

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

  • All patients who are confirmed to be taking dabigatran, rivaroxaban, apixaban, warfarin and antiplatelet therapy (aspirin, clopidogril, ticagrelor) undergoing an urgent or emergent surgical intervention by the emergency general surgery service within 24 hours of arrival to the hospital
  • 18 years of age or over

排除标准

  • Prisoners
  • Pregnant patients
  • Those who received an index operation at an outside facility and were transferred
  • Under 18 years of age

结局指标

主要结局

Rate of operative

时间窗: Oct 2019 - Aug 2021

To determine the bleeding risk and need for unplanned intervention

Number of Participants with interventional radiology

时间窗: Oct 2019 - Aug 2021

To determine the bleeding risk and need for unplanned intervention

Number of Participants with ultrasound aspiration

时间窗: Oct 2019 - Aug 2021

To determine the bleeding risk and need for unplanned intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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