Venous Thromboembolism Clinical Trial
— VTEOfficial title:
A Cross-sectional Study of Venous Thromboembolism Risk Profiles and Prophylaxis in Neurosurgical Inpatients
NCT number | NCT04257305 |
Other study ID # | KY2016-396 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | December 31, 2019 |
Verified date | February 2020 |
Source | Huashan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 9010 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Neurosurgical Inpatients. Underwent neurosurgery procedure. Exclusion Criteria: Acute or chronic respiratory failure. Acute myocardial infarction or other serious heart diseases. |
Country | Name | City | State |
---|---|---|---|
China | Huashan hospital,Fudan university | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of VTE occurrence | VTE incidence in postoperative neurosurgical patients during inhospital time from Jun 1,2018 to Dec 31,2019 | 19 months | |
Secondary | Rate of complete vessel recanalization | Complete vessel recanalization rate in postoperative neurosurgical patients during inhospital time from Jun 1,2018 to Dec 31,2019 | 19 months | |
Secondary | 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 | 19 months | |
Secondary | Rate of bleeding events | Bleeding events occurred in patients during VTE treatment | 19 months |
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