Study of Venous Thromboembolism Risk Profiles and Prophylaxis in Neurosurgical Inpatients

Venous Thromboembolism Clinical Trial

— VTE  

Official title:

A Cross-sectional Study of Venous Thromboembolism Risk Profiles and Prophylaxis in Neurosurgical Inpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04257305
• Other study ID #: KY2016-396
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Venous thromboembolism (VTE), comprising deep venous thrombosis (DVT), pulmonary embolism (PE), or both, is a life-threatening complication in postoperative patients. VTE has been estimated an incidence ranged from 79 per 100000 to 269 per 100000 population1. The incidence of VTE rises up to 3.0% in average among all postoperative neurosurgical patients in recent studies, but the number varies in a large range according to primary diseases. This cross-sectional study was aimed to investigate the incidence, associated risk factors, prophylaxis, treatment, and outcomes of VTE in a large clinical neurosurgery center in China.

Description:

Venous thromboembolism (VTE), comprising deep venous thrombosis (DVT), pulmonary embolism (PE), or both, is a life-threatening complication in postoperative patients. This cross-sectional study was aimed to investigate the incidence, associated risk factors, prophylaxis, treatment, and outcomes of VTE in a large clinical neurosurgery center in China. 9010 patients underwent neurosurgery procedure were included. Distribution of age, sex, whether received PICC during perioperative period, and some special primary diseases are significantly different between VTE and non-VTE patients. Student's test and chi-square test were performed for analyses. We investigated VTE incidence, risk factors, prophylaxes, treatment and outcomes in postoperative neurosurgical patients, and summarized the VTE susceptible population of the patients, providing a VTE patient profile for neurosurgeons to concern.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9010
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Neurosurgical Inpatients. Underwent neurosurgery procedure.

Exclusion Criteria:

Acute or chronic respiratory failure. Acute myocardial infarction or other serious heart diseases.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
China	Huashan hospital,Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of VTE occurrence	VTE incidence in postoperative neurosurgical patients during inhospital time from Jun 1,2018 to Dec 31,2019	19 months
Secondary	Rate of complete vessel recanalization	Complete vessel recanalization rate in postoperative neurosurgical patients during inhospital time from Jun 1,2018 to Dec 31,2019	19 months
Secondary	Rate of partial vessel recanalization rate	Partial vessel recanalization rate in postoperative neurosurgical patients during inhospital time from Jun 1,2018 to Dec 31,2019	19 months
Secondary	Rate of bleeding events	Bleeding events occurred in patients during VTE treatment	19 months