The Value of Novel Thrombus Markers in the Diagnosis and Treatment of Acute Pulmonary Embolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Pulmonary Embolism. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- New thrombusmarkers (TAT/PIC/TM/t-PAIC) [Time frame: 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 outcome measures (1)
- Conventional coagulation indicators, PT、APTT、FIB、D-Dimer and FDP [Time frame: 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06907238 · 3308872