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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06192199
Other study ID # NFEC-2023-501
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date December 1, 2026

Study information

Verified date January 2024
Source Nanfang Hospital, Southern Medical University
Contact Xintong Huang
Phone 8619355230761
Email 1556807596@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

From January 1, 2023 to December 30, 2023, patients who were suspected of pulmonary embolism and underwent CTPA examination at Nanyang Hospital of Southern Medical University were divided into pulmonary embolism group and non pulmonary embolism group. 1. Collect relevant data, including gender, age, primary disease, CTPA imaging and reports, BNP, troponin, electrocardiogram, cardiac ultrasound, PT, APTT, TT, fibrinogen, D-dimer, etc., and analyze demographic data, pulmonary embolism risk grading, APTT/fibrinogen ratio, and determine their cut-off values through statistical analysis of the two groups. 2. Follow up on the APTT/fibrinogen ratio after anticoagulation treatment and bleeding in the pulmonary embolism group.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date December 1, 2026
Est. primary completion date December 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Voluntary signing of informed consent form; 2. When signing the informed consent form, the age is equal to or greater than 18 years old, regardless of gender; 3. From January 1, 2023 to December 30, 2023, the patient was diagnosed with suspected pulmonary embolism at the Southern Hospital of Southern Medical University and underwent enhanced pulmonary artery scanning examination. Exclusion Criteria: 1. Patients with gastrointestinal bleeding, severe trauma, acute coronary syndrome, severe liver disease (childC grade), and coagulation dysfunction; 2. Patients with pulmonary embolism diagnosed outside the hospital and regular anticoagulation; 3. Patients undergoing regular anticoagulant therapy such as atrial fibrillation and valve replacement; 4. Patients deemed unsuitable for participation in this study by the researchers.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
2018 edition of the Guidelines for Diagnosis
According to the 2018 edition of the Guidelines for Diagnosis, Treatment and Prevention of Pulmonary Thromboembolism, and based on inclusion and exclusion criteria, enrolled patients were divided into a pulmonary embolism group and a non pulmonary embolism group

Locations

Country Name City State
China Nanfang hospital of Southern Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cutoff value of APTT/FIB between patients with and without acute pulmonary embolism 2024.01-2026.12
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