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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Venous Thromboembolic Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: hong wang, Master; Phone Number: 13791123976; Email: hongwang1971@163.com

Study Locations

• China
  • Shan Dong
    • Jinan, Shan Dong, China, 250014
      • The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
      • Contact: li li cao; Phone Number: 0531-89269891; Email: qykyc309@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From January 2023 to December 2024, 300 surgical patients with high risk of venous thrombosis admitted to the First Affiliated Hospital of Shandong First Medical University were selected as the study subjects

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: D-dimer; Thrombus Molecular Markers; venous thromboembolism risk assessment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Thromboembolism
• Other Study ID Numbers: Hong Wang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No