NCT04257305

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,010

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

February 2, 2020

Last Update Submit

February 5, 2020

Conditions

Venous Thromboembolism

Keywords

Venous thromboembolismdeep venous thrombosisneurosurgerypulmonary embolism

Outcome Measures

Primary Outcomes (1)

  • Rate of VTE occurrence

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

    19 months

Secondary Outcomes (3)

  • Rate of complete vessel recanalization

    19 months

  • Rate of partial vessel recanalization rate

    19 months

  • Rate of bleeding events

    19 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Neurosurgical Inpatients. Underwent neurosurgery procedure.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan hospital,Fudan university

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Venous ThromboembolismVenous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosisLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Shengqing Li, PhD

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician,Professor

Study Record Dates

First Submitted

February 2, 2020

First Posted

February 6, 2020

Study Start

June 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

CN(1)