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

NCT05515549 | Unknown

• 1 other identifier: Hong Wang
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolic Disease

Keywords

D-dimer; Thrombus Molecular Markers; venous thromboembolism risk assessment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Venous blood was collected from patients under fasting state to detect the level of thrombus molecular markers OTHER

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; Venous thrombosis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

Location

Study Officials

• hong wang

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hong wang, Master

CONTACT

13791123976; hongwang1971@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief nurse

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 25, 2022
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)