Acute Pulmonary EmbolismNCT06907238
The Value of Novel Thrombus Markers in the Diagnosis and Treatment of Acute Pulmonary Embolism
An observational study of Acute Pulmonary Embolism, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Acute Pulmonary Embolism
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2025to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 patients in APE group and 200 patients in non APE group each
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acute Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| APE group | Not described | |
| non APE group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
New thrombusmarkers (TAT/PIC/TM/t-PAIC)
Measured: 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 outcomes (1)
Conventional coagulation indicators, PT、APTT、FIB、D-Dimer and FDP
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start14 Oct 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Wu, Doctor, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907238
- Sponsor's protocol ID
- 3308872
- Status last verified
- Oct 2025
- First submitted
- 26 Mar 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No