Venous ThromboembolismNCT05860790
Prospective Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery
An observational study of Venous Thromboembolism and Neurosurgery, run by Capital Medical University at 1 site in China.
Trial summary
Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery: A Multicenter, Prospective, and Cohort Study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Neurosurgery, Risk Assessment
- What is being tested?
- Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2023to 1 Jul 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical patients who have undergone neurosurgery
Who may be able to join
- age >18 years
- underwent neurosurgical procedures during hospitalization
- underwent preoperative ultrasound examination
Who cannot join
- a patient with obvious bacterial or viral infection within the past two weeks before admission
- a patient with venous thromboembolism within the past three months before surgery
- a patient with anticoagulant therapy (direct oral anticoagulants, low molecular weight heparin) was administered continuously or intermittently before admission
- a patient with a prior coagulation dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sanbo Brain Hospital, Capital Medical University
Beijing
Weihai Ning, Dr., +86 15961868172, sanboocean@163.com
About this study
Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery: A Multicenter, Prospective, and Cohort Study
Read the detailed description
A clinical prediction model for VTE after neurosurgical procedures during hospitalization has been developed and internally retrospectively validated. A multicenter, prospective cohort study is planned to validate this clinical prediction model again.
- Conditions
- Venous Thromboembolism, Neurosurgery, Risk Assessment
- Being tested
- Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Prediction Model for Venous Thromboembolism Following NeurosurgeryDiagnostic test
This is a clinical prediction model that uses perioperative clinical indicators and laboratory tests to predict the occurrence of VTE after neurosurgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic or asymptomatic VTE
A combination of symptomatic or asymptomatic DVT and symptomatic or asymptomatic PE
Measured: 2023.3-2023.7
Secondary outcomes (3)
DVT
A blood clot within a deep vein, typically in the thigh or leg, which is detected with compressible ultrasound, venography, impedence plethysmography, radiofibrinogen uptake scanning or autopsy based on the time of study. This outcome combines proximal or distal DVT of the leg, upper limb DVT
Measured: 2023.3-2023.7
PE
Obstruction of a pulmonary artery or one of its branches that is usually produced by a blood clot which has originated in a vein of the leg or pelvis and traveled to the lungs, which is diagnosed by CT pulmonary angiography, ventilation-perfusion lung scanning pulmonary angiogram, or by autopsy or equivalent technology based on the time of study. This outcome combines saddle, lobar, segmental or subsegmental PE according to the anatomic location
Measured: 2023.3-2023.7
Proximal DVT
Proximal DVT is a blood clot that is located in the popliteal, femoral, or iliac veins, which is detected with compressible ultrasound, venography, impedence plethysmography, radiofibrinogen uptake scanning or autopsy based on the time of study
Measured: 2023.3-2023.7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start10 Mar 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
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 Capital Medical UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Zhang, Capital Medical University
- Investigators
- Hongwei Zhang, Prof., Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860790
- Sponsor's protocol ID
- Val. VTE pred. model post-op
- Status last verified
- May 2023
- First submitted
- 6 May 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery
- ClinicalTrials.gov ID
- NCT05860790
- Acronym / sponsor ID
- Val. VTE pred. model post-op
- Conditions
- Venous Thromboembolism, Neurosurgery, Risk Assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 16 May 2023 (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.
Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery: A Multicenter, Prospective, and Cohort Study
Detailed description
A clinical prediction model for VTE after neurosurgical procedures during hospitalization has been developed and internally retrospectively validated. A multicenter, prospective cohort study is planned to validate this clinical prediction model again.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients who have undergone neurosurgery
Key inclusion criteria (3 listed)
- age >18 years
- underwent neurosurgical procedures during hospitalization
- underwent preoperative ultrasound examination
Key exclusion criteria (4 listed)
- a patient with obvious bacterial or viral infection within the past two weeks before admission
- a patient with venous thromboembolism within the past three months before surgery
- a patient with anticoagulant therapy (direct oral anticoagulants, low molecular weight heparin) was administered continuously or intermittently before admission
- a patient with a prior coagulation dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Prediction Model for Venous Thromboembolism Following NeurosurgeryThis is a clinical prediction model that uses perioperative clinical indicators and laboratory tests to predict the occurrence of VTE after neurosurgery. | Diagnostic test | – |
Primary outcome
Symptomatic or asymptomatic VTE
Time frame: 2023.3-2023.7
A combination of symptomatic or asymptomatic DVT and symptomatic or asymptomatic PE
3 secondary outcomes
DVT
Time frame: 2023.3-2023.7
PE
Time frame: 2023.3-2023.7
Proximal DVT
Time frame: 2023.3-2023.7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
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.
Hongwei Zhang, Prof. principal investigator
Capital Medical University
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 and Neurosurgery, run by Capital Medical University 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deshan Liu, Dr. (15613318871, alfredliu@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic or asymptomatic VTE (time frame: 2023.3-2023.7). 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 16 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.