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The Value of Novel Thrombus Markers in the Diagnosis and Treatment of Acute Pulmonary Embolism

The Value of Novel Thrombus Markers in the Diagnosis and Treatment of Acute Pulmonary Embolism

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06907238
Enrollment
400
Registered
2025-04-02
Start date
2025-10-14
Completion date
2027-12-31
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pulmonary Embolism

Brief summary

In response to the high mortality rate of patients with acute pulmonary embolism (APE) and the fact that only a small proportion of deceased patients can receive correct diagnosis, this study will use a sensitive, non-invasive, and feasible new thrombus molecular marker (TAT/PIC/TM/t-PAIC) to detect and evaluate the activation of the coagulation and fibrinolysis systems and endothelial system damage in patients, in order to monitor the early diagnosis and treatment of APE, reduce mortality, and improve patient quality of life. Therefore, this study intends to include 200 newly diagnosed APE patients to evaluate the sensitivity and specificity of the single and combined application of novel thrombus molecular markers for APE diagnosis; Detect the biomarker results of patients at different time points before and after treatment, and evaluate their value in APE treatment monitoring; Track and follow up on patients after discharge to explore the prognostic value of biomarkers for APE.

Interventions

None listed

Sponsors

Beijing Anzhen Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

* 1.Patients diagnosed with APE for the first time through CTPA in clinical practice and who have not received anticoagulant therapy in the past month; 2.Age ≥ 18 years old.

Exclusion criteria

* 1\. Complicated with other thrombotic diseases, complicated with important organ damage such as heart, liver, kidney, and previous history of pulmonary embolism; 2. Malignant tumors; 3. Renal dialysis patients; 4. Antiphospholipid syndrome; 5. Immune system diseases; 6. Hematological diseases; 7. DIC caused by severe infection; 8. Patients judged by clinicians to be unfit for clinical practice.

Design outcomes

Primary

MeasureTime frame
New thrombusmarkers (TAT/PIC/TM/t-PAIC)Data of patients on the first, the fourth day, seventh and tenth days after admission for diagnosis. If the duration of hospitalization is ≤ 7 days, data will be collected only three times

Secondary

MeasureTime frame
Conventional coagulation indicators, PT、APTT、FIB、D-Dimer and FDPData of patients on the first, the fourth day, seventh and tenth days after admission for diagnosis. If the duration of hospitalization is ≤ 7 days, data will be collected only three times

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026