Clinical trial NCT04257305: Study of Venous Thromboembolism Risk Profiles and Prophylaxis in Neurosurgical Inpatients
Official title: A Cross-sectional Study of Venous Thromboembolism Risk Profiles and Prophylaxis in Neurosurgical Inpatients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Venous thromboembolism
deep venous thrombosis
neurosurgery
pulmonary embolism
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 9010
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

Neurosurgical Inpatients. Underwent neurosurgery procedure.

Exclusion Criteria:

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

Primary outcomes:
measure: Rate of VTE occurrence
timeFrame: 19 months
Secondary outcomes:
measure: Rate of complete vessel recanalization
timeFrame: 19 months
measure: Rate of partial vessel recanalization rate
timeFrame: 19 months
measure: Rate of bleeding events
timeFrame: 19 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan hospital,Fudan university
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Shengqing Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: