Venous ThromboembolismNCT04963374
the Effectiveness of Different Risk Scales In Predicting VTE in Respiratory Inpatients
An observational study of Venous Thromboembolism, run by Peking University Third Hospital at 1 site in China.
Trial summary
To compare the predictive effectiveness of the Caprini risk assessment model, the Padua risk assessment model and the VTE risk assessment in medical patients mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism on the risk of concomitant VTE in… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- risk evolution scale
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 31 Dec 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2015 to December 2020, inpatients in respiratory department, Third Hospital of Peking University
Who may be able to join
- age more than 18y respiratory inpatient
Who cannot join
- Patients with deep vein thrombosis or pulmonary thromboembolism, sequelae of deep vein thrombosis, and thrombosis in other parts of lower limbs were diagnosed; Patients with severe coagulation dysfunction or other hematological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of the Effectiveness of Different Risk Scales in Predicting Combined Venous Thrombophilia in Respiratory Inpatients
To compare the predictive effectiveness of the Caprini risk assessment model, the Padua risk assessment model and the VTE risk assessment in medical patients mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism on the risk of concomitant VTE in respiratory inpatients to provide a basis for clinical VTE assessment and treatment.
Read the detailed description
A case-control study was used to collect patients who developed VTE during hospitalization in the Department of Respiratory Medicine at Peking University Third Hospital Hospital from January 2015 to December 2020 as the case group, and 2-fold patients who did not develop VTE matched to the case group (age, sex, ADL score, diagnosis, and length of hospitalization) as the control group. The general status of the patients was also assessed using the Padua risk model, the Caprini risk model, and the VTE risk assessment scale for medical patients mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment, and prevention of pulmonary thromboembolism, and the relevant items involved in the assessment form were obtained by reviewing the cases.
- Conditions
- Venous Thromboembolism
- Being tested
- risk evolution scale
- Keywords
- VTE
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risk evolution scaleOther
Padua score、Caprini score、Prime score
| Study group | Role | What they receive |
|---|---|---|
| respiratory inpatient | respiratory inpatient with VTE Receives: Other: risk evolution scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE incidence
VTE incidence in patients with high risk of VTE
Measured: during hospitalization， an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, MD, Principal investigator, Peking UTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963374
- Sponsor's protocol ID
- Peking UTH
- Status last verified
- Nov 2023
- First submitted
- 29 Jun 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luo XY, Zhang FX. [Validation of the Caprini risk assessment model for venous thromboembolism in Chinese hospitalized patients in a general hospital]. Zhonghua Yi Xue Za Zhi. 2017 Jun 27;97(24):1875-1877. doi: 10.3760/cma.j.issn.0376-2491.2017.24.007. Chinese.
PubMed 28648012
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Effectiveness of Different Risk Scales in Predicting Combined Venous Thrombophilia in Respiratory Inpatients
- ClinicalTrials.gov ID
- NCT04963374
- Acronym / sponsor ID
- Peking UTH
- Conditions
- Venous Thromboembolism
- Keywords
- VTE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Jul 2021 (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.
To compare the predictive effectiveness of the Caprini risk assessment model, the Padua risk assessment model and the VTE risk assessment in medical patients mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism on the risk of concomitant VTE in respiratory inpatients to provide a basis for clinical VTE assessment and treatment.
Detailed description
A case-control study was used to collect patients who developed VTE during hospitalization in the Department of Respiratory Medicine at Peking University Third Hospital Hospital from January 2015 to December 2020 as the case group, and 2-fold patients who did not develop VTE matched to the case group (age, sex, ADL score, diagnosis, and length of hospitalization) as the control group. The general status of the patients was also assessed using the Padua risk model, the Caprini risk model, and the VTE risk assessment scale for medical patients mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment, and prevention of pulmonary thromboembolism, and the relevant items involved in the assessment form were obtained by reviewing the cases.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| respiratory inpatient | – | Other: risk evolution scalerespiratory inpatient with VTE |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2015 to December 2020, inpatients in respiratory department, Third Hospital of Peking University
Key inclusion criteria (1 listed)
- age more than 18y respiratory inpatient
Key exclusion criteria (1 listed)
- Patients with deep vein thrombosis or pulmonary thromboembolism, sequelae of deep vein thrombosis, and thrombosis in other parts of lower limbs were diagnosed; Patients with severe coagulation dysfunction or other hematological diseases
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 |
|---|---|---|
| risk evolution scalePadua score、Caprini score、Prime score | Other | respiratory inpatient |
Primary outcome
VTE incidence
Time frame: during hospitalization， an average of 2 weeks
VTE incidence in patients with high risk of VTE
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 22 Nov 2023.
- Background: PubMed 28648012Luo XY, Zhang FX. [Validation of the Caprini risk assessment model for venous thromboembolism in Chinese hospitalized patients in a general hospital]. Zhonghua Yi Xue Za Zhi. 2017 Jun 27;97(24):1875-1877. doi: 10.3760/cma.j.issn.0376-2491.2017.24.007. Chinese.
- Individual participant dataSharing planned: No
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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.
Jing Zhang, MD principal investigator
Peking UTH
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 Peking University Third 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 22 Nov 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?
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?
VTE incidence (time frame: during hospitalization， an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04963374, which also lists 1 linked publication.
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 22 Nov 2023.