Venous ThromboembolismVTENCT04257305
Study of Venous Thromboembolism Risk Profiles and Prophylaxis in Neurosurgical Inpatients
An observational study of Venous Thromboembolism, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 9,010 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Neurosurgical Inpatients. Underwent neurosurgery procedure.
Who cannot join
- Acute or chronic respiratory failure. Acute myocardial infarction or other serious heart diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan hospital,Fudan university
Shanghai, Shanghai Municipality, 200040
About this study
Official title: 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.
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.
- Conditions
- Venous Thromboembolism
- Keywords
- Venous thromboembolism, deep venous thrombosis, neurosurgery, pulmonary embolism
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of VTE occurrence
VTE incidence in postoperative neurosurgical patients during inhospital time from Jun 1,2018 to Dec 31,2019
Measured: 19 months
Secondary outcomes (3)
Rate of complete vessel recanalization
Complete vessel recanalization rate in postoperative neurosurgical patients during inhospital time from Jun 1,2018 to Dec 31,2019
Measured: 19 months
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
Measured: 19 months
Rate of bleeding events
Bleeding events occurred in patients during VTE treatment
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Jun 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 9,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengqing Li, Huashan Hospital
- Investigators
- Shengqing Li, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257305
- Sponsor's protocol ID
- KY2016-396
- Acronym
- VTE
- Status last verified
- Feb 2020
- First submitted
- 2 Feb 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of Venous Thromboembolism Risk Profiles and Prophylaxis in Neurosurgical Inpatients
- ClinicalTrials.gov ID
- NCT04257305
- Acronym / sponsor ID
- VTE / KY2016-396
- Conditions
- Venous Thromboembolism
- Keywords
- Venous thromboembolism, deep venous thrombosis, neurosurgery, pulmonary embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,010 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Neurosurgical Inpatients. Underwent neurosurgery procedure.
Key exclusion criteria (1 listed)
- Acute or chronic respiratory failure. Acute myocardial infarction or other serious heart diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Rate of complete vessel recanalization
Time frame: 19 months
Rate of partial vessel recanalization rate
Time frame: 19 months
Rate of bleeding events
Time frame: 19 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengqing Li, PhD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of VTE occurrence (time frame: 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.