Prospective Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery

Venous Thromboembolism Clinical Trial

Official title:

Prospective Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860790
• Other study ID #: Val. VTE pred. model post-op
• Status: Recruiting
• Start date: March 10, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: May 2023
• Source: Capital Medical University
• Contact: Deshan Liu, Dr.
• Phone: 15613318871
• Email: alfredliu[@]mail.ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery: A Multicenter, Prospective, and Cohort Study

Description:

A clinical prediction model for VTE after neurosurgical procedures during hospitalization has been developed and internally retrospectively validated. A multicenter, prospective cohort study is planned to validate this clinical prediction model again.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age >18 years

2. underwent neurosurgical procedures during hospitalization

3. underwent preoperative ultrasound examination

Exclusion Criteria:

1. a patient with obvious bacterial or viral infection within the past two weeks before admission

2. a patient with venous thromboembolism within the past three months before surgery

3. a patient with anticoagulant therapy (direct oral anticoagulants, low molecular weight heparin) was administered continuously or intermittently before admission

4. a patient with a prior coagulation dysfunction

Related Conditions & MeSH terms

• Neurosurgery
• Risk Assessment
• Thromboembolism
• Venous Thromboembolism

Intervention

Diagnostic Test:
• Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery
This is a clinical prediction model that uses perioperative clinical indicators and laboratory tests to predict the occurrence of VTE after neurosurgery.

Locations

Country	Name	City	State
China	Sanbo Brain Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic or asymptomatic VTE	A combination of symptomatic or asymptomatic DVT and symptomatic or asymptomatic PE	2023.3-2023.7
Secondary	DVT	A blood clot within a deep vein, typically in the thigh or leg, which is detected with compressible ultrasound, venography, impedence plethysmography, radiofibrinogen uptake scanning or autopsy based on the time of study. This outcome combines proximal or distal DVT of the leg, upper limb DVT	2023.3-2023.7
Secondary	PE	Obstruction of a pulmonary artery or one of its branches that is usually produced by a blood clot which has originated in a vein of the leg or pelvis and traveled to the lungs, which is diagnosed by CT pulmonary angiography, ventilation-perfusion lung scanning pulmonary angiogram, or by autopsy or equivalent technology based on the time of study. This outcome combines saddle, lobar, segmental or subsegmental PE according to the anatomic location	2023.3-2023.7
Secondary	Proximal DVT	Proximal DVT is a blood clot that is located in the popliteal, femoral, or iliac veins, which is detected with compressible ultrasound, venography, impedence plethysmography, radiofibrinogen uptake scanning or autopsy based on the time of study	2023.3-2023.7