Prospective Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery

Recruiting

• Conditions: Neurosurgery; Venous Thromboembolism; Risk Assessment

• Registration Number: NCT05860790
• Lead Sponsor: Capital Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-03-10
• Status Verified: 2023-05
• Study First Submitted: 2023-05-06
• Study First Submitted QC: 2023-05-06
• Last Update Submitted: 2023-05-06
• Study First Posted: 2023-05-16
• Last Update Posted: 2023-05-16
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic or asymptomatic VTE	2023.3-2023.7	A combination of symptomatic or asymptomatic DVT and symptomatic or asymptomatic PE

Secondary Outcome Measures

Name	Time	Method
DVT	2023.3-2023.7	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
PE	2023.3-2023.7	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
Proximal DVT	2023.3-2023.7	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

Trial Locations

Locations (1)

Sanbo Brain Hospital, Capital Medical University; 🇨🇳 Beijing, China