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

Venous Thromboembolic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05515549
• Other study ID #: Hong Wang
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: Qianfoshan Hospital
• Contact: hong wang, Master
• Phone: 13791123976
• Email: hongwang1971[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Thrombosis
• Venous Thromboembolic Disease

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital	Jinan	Shan Dong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether venous thrombosis occurs	On the 13th day after the patient's admission, color Doppler ultrasound will be performed to determine whether the patient has venous thrombosis	On the 13th day after the patient's admission