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Adaptive Research on Risk Prediction of Deep Vein Thrombosis and immunomodulatory Therapy Based on Multimodal electronic Health Data

Adaptive Research on Risk Prediction of Deep Vein Thrombosis and immunomodulatory Therapy Based on Multimodal electronic Health Data

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126445
Enrollment
Unknown
Registered
2026-06-09
Start date
2027-01-01
Completion date
Unknown
Last updated
2026-06-15

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

Conditions

deep venous thrombosis

Interventions

Non-DVT Patient Group vs. DVT Patient Group:None

Sponsors

Quanzhou First Hospital, Fujian
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years old, regardless of gender. 2. Assessed as high-risk patients by the "DVT Risk Prediction Model" constructed in this study (risk score in the top 10% or reaching the pre-set high-risk threshold). 3. Laboratory tests show a clear state of immune-inflammatory activation, such as levels of neutrophil extracellular traps (NETs)-related markers (e.g., MPO-DNA complexes) being significantly higher than the upper limit of normal reference values (e.g., 2 times the normal value or higher), or meeting other abnormal criteria for immune markers pre-set in the study protocol. 4. The subject or their legal representative is able to fully understand the purpose, procedures, potential risks, and benefits of this study, voluntarily participates, and signs a written informed consent form. 5. The subject is willing and able to comply with the study protocol to complete treatment, follow-up, laboratory tests, and other study procedures.

Exclusion criteria

Exclusion criteria: 1. Presence of active bleeding or judged by the investigator to have an extremely high risk of bleeding (e.g., a recent history of intracranial hemorrhage, massive gastrointestinal bleeding, etc.). 2. Known severe hepatic impairment (e.g., ALT/AST > 3 times the upper limit of normal) or severe renal impairment (eGFR < 30 mL/min/1.73m²). 3. Known history of allergy to any of the drugs used in this study (including standard anticoagulants and immunomodulators). 4. Pregnant or lactating women, or women with pregnancy plans during the study period. 5. Currently participating in other interventional clinical trials (within 30 days prior to enrollment). 6. Suffering from other severe, uncontrolled systemic diseases, or other conditions that the investigator believes may affect the safety of the subject or the judgment of the study results. 7. Persons without capacity or with limited capacity for civil conduct who are unable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Area under the curve (AUC);F1-score;

Secondary

MeasureTime frame
Demographic characteristic indicators: age, gender, BMI, smoking history, drinking history.;Biochemical and coagulation parameters: D-dimer peak, prothrombin time (PT), activated partial thromboplastin time (APTT), platelet count (PLT), hemoglobin (Hb), C-reactive protein (CRP), and interleukin-6 (IL-6).;Chronic disease and comorbidities indicators: diabetes, hypertension, heart failure, history of malignant tumors.;Perioperative characteristic indicators: type of surgery (such as orthopedics, general surgery, obstetrics and gynecology, etc.), type of anesthesia, and duration of surgery.;

Countries

China

Contacts

Public ContactJuanjuan Zheng

Quanzhou First Hospital, Fujian

332100103@qq.com+86 595 8558 5856

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026