SepThrom: Exploring the Relationship Between Sepsis, VTE and DIC in RWD.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Prevalence of diagnosed DIC among hospitalized people with sepsis-associated VTE
研究概览
简要总结
This is an observational study in which data already collected from people with venous thromboembolism (VTE) due to sepsis (blood poisoning) are studied. These people were hospitalized in an intensive care unit (ICU) and may or may not have had disseminated intravascular coagulation (DIC).
In this observational study, only observations are made without participants receiving any advice or changes to their healthcare.
VTE is a condition that occurs when blood clots form in the veins, which can be dangerous. DIC is a serious blood disorder that can cause clots throughout the body, blocking blood flow. People who have sepsis are at a higher risk of developing both VTE and DIC. Researchers wanted to know if people who have sepsis developed DIC before developing VTE.
To prevent VTE in people with sepsis, it is important to know how severe the sepsis is, how it progresses, and whether DIC is also present or not.
In this study, researchers will assess patient data from a medical database in the United States (US).
The main purpose of this study is to learn if there is a relationship between sepsis, DIC, and VTE.
To do this, researchers will divide the participants with VTE due to sepsis into three groups as follows:
- participants who were diagnosed with DIC based on the extent of blood clotting
- participants who likely had DIC but it was not diagnosed
- participants who did not develop DIC during the same hospital visit
The researchers will collect the following information:
- the number of participants who had VTE due to sepsis also had DIC
- the change in participants' laboratory results and vital signs, such as heart rate and blood pressure, from the time their sepsis was diagnosed to the time their VTE and DIC were diagnosed
The researchers will study the data collected between January 2007 and December 2021.
The data will come from the participants' information stored in a database called the Optum VTE EHR which collects patient medical data from hospitals across the US.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •admitted to an ICU with the diagnosis of VTE and sepsis during the same hospital ICU admission
排除标准
- •less than 18 yrs old
- •less than 365 days data available prior to index VTE
研究组 & 干预措施
No DIC
Patients with no DIC within the same hospital stay
干预措施: Diagnosis of both VTE and sepsis (Other)
Diagnosed DIC
Patients with ICD10 (International Classification of Diseases) code for DIC
干预措施: Diagnosis of both VTE and sepsis (Other)
Undiagnosed DIC
Patients with SIC (Sepsis Induced Coagulopathy) score of >/= 4
干预措施: Diagnosis of both VTE and sepsis (Other)
结局指标
主要结局
Prevalence of diagnosed DIC among hospitalized people with sepsis-associated VTE
时间窗: Retrospective analysis of 15 year dataset
Proportion of undiagnosed DIC among hospitalized people with sepsis-associated VTE
时间窗: Retrospective analysis of 15 year dataset
Based on trajectory of laboratory and vital sign data from the time of sepsis ICD10 coding to the time of VTE coding and to the time of DIC coding
次要结局
未报告次要终点