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RecruitingNCT05969951Updated Aug 1, 2023

VTE Risk Prevention System Based on Big Data Analysis and Multimodule System

An observational study in Recruiting, sponsored by Shengjing Hospital. Recruiting at 1 site in China. Open to participants aged 10 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by Shengjing Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Apr 2021; still recruiting 5 years 5 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100,000
Ages
10 Years to 90 Years
Sex
All
01

Study summary

Venous thromboembolism (VTE) is one of the most common complications in perioperative period and the most common cause of postoperative death. VTE includes deep vein thrombosis (DVT) and acute pulmonary thromboembolism (PTE). Since the embolus of PTE comes from the deep vein thrombosis, and not all PE patients can present obvious clinical symptoms, VTE is currently considered as a disease for research, prevention, diagnosis and treatment at home and abroad. Therefore, we urgently need to develop a more comprehensive and reliable perioperative VTE risk prevention system based on medical big data and multi-module computer in current clinical practice, so as to effectively guide the prevention of DVT/PE, and thus reduce the perioperative mortality.

Read the detailed description

Venous thromboembolism (VTE) is one of the most common complications in perioperative period and the most common cause of postoperative death. VTE includes deep vein thrombosis (DVT) and acute pulmonary thromboembolism (PTE). Since the embolus of PTE comes from the deep vein thrombosis, and not all PE patients can present obvious clinical symptoms, VTE is currently considered as a disease for research, prevention, diagnosis and treatment at home and abroad. Therefore, we urgently need to develop a more comprehensive and reliable perioperative VTE risk prevention system based on medical big data and multi-module computer in current clinical practice, so as to effectively guide the prevention of DVT/PE, and thus reduce the perioperative mortality.

As early as 1991, Caprini et al. collated and published the clinical scale of VTE risk assessment based on the study data of 538 patients. In 2010, Caprini et al. conducted retrospective verification of this scale again among 8216 patients, thus making this scale an important reference for many medical institutions to assess the risk of VTE occurrence in perioperative patients, and it has been used ever since. However, over the past 30 years, the disease spectrum, surgical methods, anesthesia methods and the cognition of thrombus formation susceptibility of surgical patients have all undergone great changes. Perioperative patients who are evaluated by Caprini scale and take preventive measures according to its suggested measures will still have postoperative VTE. Therefore, in recent years, scholars have published new VTE risk prediction methods, such as Kucher model, Padua model and so on. However, the study cases established by the model are almost only about 1000 cases, and the included research indicators are limited.

The new technology realizes for the first time the identification, reading and integration of VTE-related risk indicators under the guidance of informatization and digitalization, providing technical support for big data analysis; To realize forward-looking, big data, multi-variable, multi-module VTE-related risk assessment and prediction; The existing scoring system should be improved to provide a more reliable and operable scoring model for perioperative VTE prevention and treatment.

02

Conditions studied

  • Recruiting
03

In context

Lead sponsor

Shengjing Hospital is the lead sponsor of 124 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients in the perioperative period between 10-90

Inclusion criteria

  1. perioperative patients;
  2. Age range from 10 to 90 years old, gender unlimited;
  3. Sign informed consent.

Exclusion criteria

Exclusion Criteria:

  • (1) non-operative patients; (2) have developed deep vein thrombosis and/or pulmonary embolism before surgery; (3) emergency operation patients; (4) Patients considered unsuitable for inclusion in the study.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • New scoring mode group

    Patients were evaluated for VTE risk in the perioperative period using a new scoring system

  • Caprini group

    Patients were evaluated for VTE risk in the perioperative period using Caprini scoring system

06

What researchers measure

Primary outcomes

  1. DVT incidence rate

    Incidence of perioperative deep venous thromboembolism

    Time frame: 7±2days after operation

  2. PE incidence rate

    Incidence of perioperative acute pulmonary thromboembolism

    Time frame: 7±2days after operation

07

Study locations

1 of 1 sites recruiting
  • Shengjing Hospital of China Medical University
    Shenyang, Liaoning 110004, China
    • Yu Li, master · Contact · sundy_liyu@163.com · +8602496615-21111
    • Chuming Zhou, master · Contact · zcm_06@163.com · +8602496615-21111
    • Li Zhao, Doctor · Principal investigator
    • Yu Li, Master · Sub investigator
    • Chuming Zhou, Master · Sub investigator
    Recruiting
08

References and documents

Publications

  • Cronin M, Dengler N, Krauss ES, Segal A, Wei N, Daly M, Mota F, Caprini JA. Completion of the Updated Caprini Risk Assessment Model (2013 Version). Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619838052. doi: 10.1177/1076029619838052. PubMed 30939900 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05969951
Lead sponsor
Shengjing Hospital
Responsible party
LI ZHAO (LI ZHAO, Shengjing Hospital) — Principal investigator
First posted
Aug 1, 2023
Start date
Apr 14, 2021
Primary completion
Dec 2025 (estimated)
Completion
Apr 2026 (estimated)
Last update
Aug 1, 2023

Study contacts

Chuming Zhou, master
Contact
zcm_06@163.com
+8602496615-21111
Yu Li, master
Contact
sundy_liyu@163.com
+8602496615-21111

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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