Clinical trial NCT05515549: Value of D-dimer Combined With Other Thrombus Molecular Markers in Risk Assessment of VTE in Hospitalized Patients
Official title: Value of D-dimer Combined With Other Thrombus Molecular Markers in Risk Assessment of VTE in Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Thromboembolic Disease
Keywords: D-dimer
Thrombus Molecular Markers
venous thromboembolism risk assessment
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Whether venous thrombosis occurs
timeFrame: On the 13th day after the patient's admission
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
state: Shan Dong
Study officials:
affiliation: Shandong First Medical University
name: hong wang
role: PRINCIPAL_INVESTIGATOR
References: