CClinicalTrials.gg
CompletedNCT04257305VTEUpdated Feb 6, 2020

Study of Venous Thromboembolism Risk Profiles and Prophylaxis in Neurosurgical Inpatients

An observational study in Venous Thromboembolism, sponsored by Huashan Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2020-02-06.

Sponsored by Huashan Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
9,010
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Venous Thromboembolism

Keywords

  • Venous thromboembolism
  • deep venous thrombosis
  • neurosurgery
  • pulmonary embolism
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's enrollment of 9,010 is above the median of 500 across 344 observational studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

Neurosurgical Inpatients. Underwent neurosurgery procedure.

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
9,010 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Rate of VTE occurrence

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

    Time frame: 19 months

Secondary outcomes

  1. Rate of complete vessel recanalization

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

    Time frame: 19 months

  2. 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

    Time frame: 19 months

  3. Rate of bleeding events

    Bleeding events occurred in patients during VTE treatment

    Time frame: 19 months

07

Study locations

1 site
  • Huashan hospital,Fudan university
    Shanghai, Shanghai 200040, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04257305
Lead sponsor
Huashan Hospital
Responsible party
Shengqing Li (Chief Physician,Professor, Huashan Hospital) — Principal investigator
First posted
Feb 6, 2020
Start date
Jun 1, 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Feb 6, 2020

Study contacts

Shengqing Li, PhD
principal investigator · Huashan Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion