RecruitingNCT05969951
VTE Risk Prevention System Based on Big Data Analysis and Multimodule System
An observational study of Recruiting, run by Shengjing Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Recruiting
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2021to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients in the perioperative period between 10-90
Who may be able to join
- perioperative patients;
- Age range from 10 to 90 years old, gender unlimited;
- Sign informed consent.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Yu Li, master, +8602496615-21111, sundy_liyu@163.com
Chuming Zhou, master, +8602496615-21111, zcm_06@163.com
About this study
Official title: Construction of Perioperative Venous Thromboembolism Risk Prevention System Based on Big Data Analysis and Multimodule System
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.
- Conditions
- Recruiting
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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DVT incidence rate
Incidence of perioperative deep venous thromboembolism
Measured: 7±2days after operation
PE incidence rate
Incidence of perioperative acute pulmonary thromboembolism
Measured: 7±2days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start14 Apr 2021
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RecruitingStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI ZHAO, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969951
- Sponsor's protocol ID
- ShengjingH
- Status last verified
- Apr 2023
- First submitted
- 23 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Perioperative Venous Thromboembolism Risk Prevention System Based on Big Data Analysis and Multimodule System
- ClinicalTrials.gov ID
- NCT05969951
- Acronym / sponsor ID
- ShengjingH
- Conditions
- Recruiting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients in the perioperative period between 10-90
Key inclusion criteria (3 listed)
- perioperative patients;
- Age range from 10 to 90 years old, gender unlimited;
- Sign informed consent.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DVT incidence rate
Time frame: 7±2days after operation
Incidence of perioperative deep venous thromboembolism
PE incidence rate
Time frame: 7±2days after operation
Incidence of perioperative acute pulmonary thromboembolism
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 30939900Cronin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recruiting, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuming Zhou, master (+8602496615-21111, zcm_06@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DVT incidence rate (time frame: 7±2days after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05969951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.