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Completed

NCT Number: NCT04257305

Study of Venous Thromboembolism Risk Profiles and Prophylaxis in Neurosurgical Inpatients

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Huashan hospital,Fudan university

Shanghai, Shanghai Municipality, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Neurosurgical Inpatients. Underwent neurosurgery procedure.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Rate of VTE occurrence

    Time frame: 19 months

    VTE incidence in postoperative neurosurgical patients during inhospital time from Jun 1,2018 to Dec 31,2019

Secondary outcomes

  1. Rate of complete vessel recanalization

    Time frame: 19 months

    Complete vessel recanalization rate in postoperative neurosurgical patients during inhospital time from Jun 1,2018 to Dec 31,2019

  2. Rate of partial vessel recanalization rate

    Time frame: 19 months

    Partial vessel recanalization rate in postoperative neurosurgical patients during inhospital time from Jun 1,2018 to Dec 31,2019

  3. Rate of bleeding events

    Time frame: 19 months

    Bleeding events occurred in patients during VTE treatment

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Acronym: VTE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2020
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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