跳至主要内容
临床试验/NCT06168331
NCT06168331招募中不适用

Chinese Community Inpatient Thromboembolism: a Cross-sectional Study

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 1,152 人开始时间: 2023年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,152
试验地点
1
主要终点
Lower extremity venous ultrasound VTE event

研究概览

简要总结

This study is a multicenter cross-sectional study conducted at 20 centers. Data of existing inpatients in 20 community hospitals were collected. Information collected included demographic, co-morbidities, co-medication, laboratory tests, imaging tests, and anticoagulant use. Based on Caprini, Padua, Khorana and PAPT rating tables, VTE risk assessment was carried out for inpatients from 20 community hospitals, and VTE risk stratification of patients and prevention of high-risk VTE patients were analyzed. Blood samples of inpatients were collected to determine coagulation function indicators. VTE screening was performed on hospitalized patients using color Doppler ultrasound to determine the incidence of VTE in community hospitalized patients. On this basis, the predictive efficacy of different VTE risk scores on community hospitalized patients was compared, and a new VTE risk score conforming to community hospitalized patients was constructed.

详细描述

This study was a prospective, multicenter, observational cohort study conducted in a cross-section of 20 eligible community hospitals.

Data of existing inpatients in 20 community hospitals were collected. Information collected included demographic, co-morbidities, co-medication, laboratory tests, imaging tests, and anticoagulant use. Inpatients from 20 community hospitals were evaluated for VTE risk by integrating scores such as Caprini, Padua, Khorana and PAPT, and their ability to perform activities of daily living was also evaluated. The stratification of VTE risk and the prevention of VTE in high-risk patients were analyzed, and the efficacy of different VTE risk scores in predicting VTE in community inpatients was compared. VTE risk score was constructed by Delphi method to simplify the clinical VTE evaluation process.

Delphi method was used to construct a VTE risk scoring process: 1) This study initially proposed several VTE risk indicators such as age, length of stay and score of autonomous activity ability through literature review. After analysis, discussion and rectification, the research team members screened the indicators according to the construction principles of the indicator system, and finally preliminatively determined the level and quantity of sensitive indicators. 2) Design expert letter questionnaire: This study plans to conduct a total of 3 rounds of letter questionnaire, which will be distributed and recovered by face-to-face presentation or email. 15 clinical experts with senior titles who have worked in VTE related research fields for more than 10 years, including clinicians, clinical pharmacists and nurses, etc., will be invited. Experts will evaluate all levels and indicators one by one. Likert 5-level scoring method will be adopted for the importance score, and 1-5 points will be assigned according to "not important" to "very important". Modifications, additions or other comments on indicators will be recorded in the expert opinion column. 3) Pairwise comparison of indicators at all levels in the third round of expert letter questionnaire was carried out, and the pairwise comparative importance of each indicator was assigned by the 9-level scale of analytic Hierarchy Process (AHP). Matrix judgment and weight were determined according to the expert evaluation results. Determine the final VTE risk score.

Lower extremity venous ultrasound was performed on more than 1000 patients to obtain the current incidence of VTE among hospitalized patients in the community.

Blood samples were collected from more than 1000 patients, and blood samples from hospitalized patients were collected to determine coagulation function indexes, including prothrombin time, fibrinogen, partial thromboplastin time, thrombin time, fibrin degradation products, D-D dimer, and coagulation active factors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Inpatients in community service centers
  • Patients or guardians agree with the study plan and sign the informed consent.

排除标准

  • Outpatients in community service centers
  • The patient or guardian does not agree to sign the informed consent.

结局指标

主要结局

Lower extremity venous ultrasound VTE event

时间窗: This is a cross-sectional study, patients will be examined Day0 when incorporated into study

Both lower limb venous B-ultrasonography will be performed on the patients to examine whether the patient has VTE event

次要结局

  • D-Dimer D-Dimer D-Dimer D-Dimer level(This is a cross-sectional study, patients will be examined Day0 when incorporated into study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhi-chun Gu

associate professor of pharmacy

RenJi Hospital

研究点 (1)

Loading locations...

相似试验