Study of Venous Thromboembolism Risk Profiles and Prophylaxis in Neurosurgical Inpatients (VTE)

February 5, 2020 updated by: Shengqing Li, Huashan Hospital

A Cross-sectional 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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

9010

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital，Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

9010 patients underwent neurosurgery procedure were included from Jun 1, 2018 to Dec 31, 2019 in Huashan Hospital. Clinical data about demographic information, VTE incidence, primary diseases, laboratory indexes, treatment, and outcomes were collected.

Description

Inclusion Criteria:

Neurosurgical Inpatients. Underwent neurosurgery procedure.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
19 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
19 months
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
19 months
Rate of bleeding events
Time Frame: 19 months
Bleeding events occurred in patients during VTE treatment
19 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Shengqing Li, PhD, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

February 2, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2016-396

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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