NCT05969951

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

August 1, 2023

Status Verified

April 1, 2023

Enrollment Period

4.6 years

First QC Date

July 23, 2023

Last Update Submit

July 23, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • DVT incidence rate

    Incidence of perioperative deep venous thromboembolism

    7±2days after operation

  • PE incidence rate

    Incidence of perioperative acute pulmonary thromboembolism

    7±2days after operation

Study Arms (2)

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

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients in the perioperative period between 10-90

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30939900BACKGROUND

Central Study Contacts

Chuming Zhou, master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LI ZHAO

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 1, 2023

Study Start

April 14, 2021

Primary Completion

December 1, 2025

Study Completion

April 1, 2026

Last Updated

August 1, 2023

Record last verified: 2023-04

Locations