Value of D-dimer Combined With Other Thrombus Molecular Markers in Risk Assessment of VTE in Hospitalized Patients

Sponsor
Qianfoshan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05515549
Collaborator
(none)
300
1
23
13

Study Details

Study Description

Brief Summary

The occurrence of VTE in hospital is an important cause of unexpected death of inpatients, and has become a serious problem faced by hospital managers and clinical medical staff.Under the target of "Improving the Standard Prevention Rate of Venous Thromboembolism" proposed in the "National Medical Quality and Safety Improvement Goal in 2022", it is urgent to establish a highly sensitive VTE risk assessment and monitoring system.At present, VTE risk assessment scale is used for risk screening and monitoring in combination with D-dimer in clinical practice, but D-dimer has low specificity and poor sensitivity, which makes it impossible to accurately assess the risk of venous thrombosis.Therefore, it is very important to explore highly specific molecular markers of thrombosis for VTE risk assessment.This project will analyze the value of single or combined detection of different thrombus molecular markers in VTE risk assessment, establish the best VTE risk assessment scheme, improve the standardized prevention of VTE, realize the early intervention of VTE, truly achieve early detection, early prevention and early treatment, and effectively reduce the occurrence of VTE.

Condition or Disease Intervention/Treatment Phase
  • Other: Venous blood was collected from patients under fasting state to detect the level of thrombus molecular markers

Detailed Description

This project is intended to explore the specificity and reliability of single or combined detection of different thrombus molecular markers in venous thrombosis risk assessment by detecting and analyzing the levels of various thrombus molecular markers in VTE high-risk patients, so as to establish the best evaluation strategy for early identification of VTE high-risk patients, build the hospital VTE early warning management system, guide the clinical to formulate targeted graded intervention measures, and effectively reduce the occurrence of VTE. At the same time, it will provide support for the realization of "improving the standard prevention rate of venous thromboembolism" proposed in the national medical quality and safety improvement goal in 2022 and reducing medical risks.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Value of D-dimer Combined With Other Thrombus Molecular Markers in Risk Assessment of VTE in Hospitalized Patients
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Venous thrombosis group

The venous blood of the patients under fasting state was collected, and the level of thrombus molecular markers was detected. Color Doppler ultrasound was used as the "gold standard" to determine whether VTE occurred.

Other: Venous blood was collected from patients under fasting state to detect the level of thrombus molecular markers
The venous blood of the patients in fasting state was collected to detect the level of thrombus molecular markers. Color Doppler ultrasound was used as the "gold standard" to determine whether VTE occurred. According to the color Doppler ultrasound diagnosis results, the patients were divided into VTE group and non VTE group.

Group without venous thrombosis

The venous blood of the patients under fasting state was collected, and the level of thrombus molecular markers was detected. Color Doppler ultrasound was used as the "gold standard" to determine whether VTE occurred.

Other: Venous blood was collected from patients under fasting state to detect the level of thrombus molecular markers
The venous blood of the patients in fasting state was collected to detect the level of thrombus molecular markers. Color Doppler ultrasound was used as the "gold standard" to determine whether VTE occurred. According to the color Doppler ultrasound diagnosis results, the patients were divided into VTE group and non VTE group.

Outcome Measures

Primary Outcome Measures

  1. Whether venous thrombosis occurs [On the 13th day after the patient's admission]

    On the 13th day after the patient's admission, color Doppler ultrasound will be performed to determine whether the patient has venous thrombosis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age ≥ 18 years

  • Surgical inpatients

  • Patients who were assessed as high-risk by venous thrombosis risk assessment after admission (caprini score ≥5)

  • Did not receive anticoagulation or thrombolysis before admission

  • Patients without chronic cardiovascular disease, autoimmune disease, malignant tumor and other diseases

  • Patients without previous history of venous thrombosis of lower limbs

  • The molecular markers of thrombus were detected routinely at admission

  • The family members of the patients signed informed consent

Exclusion Criteria:
  • Abnormal coagulation function due to blood disease or severe liver and kidney dysfunction

  • Patients with major trauma or vegetative survival within 3 months

  • Patients with long-term use of anticoagulant drugs, glucocorticoids and hemostatic drugs

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital Jinan Shan Dong China 250014

Sponsors and Collaborators

  • Qianfoshan Hospital

Investigators

  • Principal Investigator: hong wang, The First Affiliated Hospital of Shandong First Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hong Wang, associate chief nurse, Qianfoshan Hospital
ClinicalTrials.gov Identifier:
NCT05515549
Other Study ID Numbers:
  • Hong Wang
First Posted:
Aug 25, 2022
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hong Wang, associate chief nurse, Qianfoshan Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022