- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06192199
The Diagnostic Value of APTT/Fibrinogen Ratio in Pulmonary Embolism
January 18, 2024 updated by: Nanfang Hospital, Southern Medical University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xintong Huang
- Phone Number: 8619355230761
- Email: 1556807596@qq.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Recruiting
- Nanfang Hospital of Southern Medical University
-
Contact:
- Xintong Huang
- Phone Number: 8619355230761
- Email: 1556807596@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
From January 1, 2023 to December 30, 2023, the patients were diagnosed with suspected pulmonary embolism at the Southern Hospital of Southern Medical University and underwent enhanced pulmonary artery scanning examination.
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
Description
Inclusion Criteria:
- Voluntary signing of informed consent form;
- When signing the informed consent form, the age is equal to or greater than 18 years old, regardless of gender;
- 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:
- Patients with gastrointestinal bleeding, severe trauma, acute coronary syndrome, severe liver disease (childC grade), and coagulation dysfunction;
- Patients with pulmonary embolism diagnosed outside the hospital and regular anticoagulation;
- Patients undergoing regular anticoagulant therapy such as atrial fibrillation and valve replacement;
- Patients deemed unsuitable for participation in this study by the researchers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with acute pulmonary embolism
|
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
|
Patients without acute pulmonary embolism
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cutoff value of APTT/FIB between patients with and without acute pulmonary embolism
Time Frame: 2024.01-2026.12
|
2024.01-2026.12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
December 14, 2023
First Submitted That Met QC Criteria
January 3, 2024
First Posted (Actual)
January 5, 2024
Study Record Updates
Last Update Posted (Actual)
January 22, 2024
Last Update Submitted That Met QC Criteria
January 18, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NFEC-2023-501
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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