The Diagnostic Value of APTT/Fibrinogen Ratio in Pulmonar... | NCT06192199

Studies
The Diagnostic Value of APTT/Fibrinogen Ratio in Pulmonary Embolism

NCT06192199

Sponsor

Nanfang Hospital, Southern Medical University

Status

Completed

Last Update Posted

Jul 1, 2026Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Acute Pulmonary Embolism

Interventions

2018 edition of the Guidelines for Diagnosis

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Jul 1, 2025Actual

Completion Date

Dec 1, 2025Actual

First Submitted Date

Dec 14, 2023

First Submission Date that Met QC Criteria

Jan 3, 2024

First Posted Date

Jan 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2026

Last Update Posted Date

Jul 1, 2026Actual

Name	Class
Shenzhen Nanshan Hospital	UNKNOWN
Ganzhou City People's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with acute pulmonary embolism			Diagnostic Test: 2018 edition of the Guidelines for Diagnosis
Patients without acute pulmonary embolism			Diagnostic Test: 2018 edition of the Guidelines for Diagnosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2018 edition of the Guidelines for Diagnosis	Diagnostic Test	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

Measure	Description	Time Frame
Cutoff value of APTT/FIB between patients with and without acute pulmonary embolism		2024.01-2026.12

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample