Venous ThromboembolismCOMETNCT06168331
Chinese Community Inpatient Thromboembolism
An observational study of Venous Thromboembolism, run by RenJi Hospital at 2 sites in China.
Trial summary
This study is a multicenter cross-sectional study conducted at 20 centers. Data of existing inpatients in 20 community hospitals were collected. Information collected included demographic, co-morbidities, co-medication, laboratory tests, imaging tests, and anticoagulant use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 1,152 participants
- Where
- 2 sitesChina
- Study dates
- 10 Oct 2023to 31 Dec 2024
- 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
- Adult, Older adult
Study population: Inpatients from 20 community health service centers in Shanghai.
Who may be able to join
- Inpatients in community service centers
- Patients or guardians agree with the study plan and sign the informed consent.
Who cannot join
- Outpatients in community service centers
- The patient or guardian does not agree to sign the informed consent.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Active, not recruiting
Department of Pharmacy, Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
- Recruiting
Department of Pharmacy, Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Meng Hu, PhD, +86 15000090636, humeng@renji.com
About this study
Official title: Chinese Community Inpatient Thromboembolism: a Cross-sectional Study
This study is a multicenter cross-sectional study conducted at 20 centers. Data of existing inpatients in 20 community hospitals were collected. Information collected included demographic, co-morbidities, co-medication, laboratory tests, imaging tests, and anticoagulant use. Based on Caprini, Padua, Khorana and PAPT rating tables, VTE risk assessment was carried out for inpatients from 20 community hospitals, and VTE risk stratification of patients and prevention of high-risk VTE patients were analyzed. Blood samples of inpatients were collected to determine coagulation function indicators. VTE screening was performed on hospitalized patients using color Doppler ultrasound to determine the incidence of VTE in community hospitalized patients. On this basis, the predictive efficacy of different VTE risk scores on community hospitalized patients was compared, and a new VTE risk score conforming to community hospitalized patients was constructed.
Read the detailed description
This study was a prospective, multicenter, observational cohort study conducted in a cross-section of 20 eligible community hospitals.
Data of existing inpatients in 20 community hospitals were collected. Information collected included demographic, co-morbidities, co-medication, laboratory tests, imaging tests, and anticoagulant use. Inpatients from 20 community hospitals were evaluated for VTE risk by integrating scores such as Caprini, Padua, Khorana and PAPT, and their ability to perform activities of daily living was also evaluated. The stratification of VTE risk and the prevention of VTE in high-risk patients were analyzed, and the efficacy of different VTE risk scores in predicting VTE in community inpatients was compared. VTE risk score was constructed by Delphi method to simplify the clinical VTE evaluation process.
Delphi method was used to construct a VTE risk scoring process: 1) This study initially proposed several VTE risk indicators such as age, length of stay and score of autonomous activity ability through literature review. After analysis, discussion and rectification, the research team members screened the indicators according to the construction principles of the indicator system, and finally preliminatively determined the level and quantity of sensitive indicators. 2) Design expert letter questionnaire: This study plans to conduct a total of 3 rounds of letter questionnaire, which will be distributed and recovered by face-to-face presentation or email. 15 clinical experts with senior titles who have worked in VTE related research fields for more than 10 years, including clinicians, clinical pharmacists and nurses, etc., will be invited. Experts will evaluate all levels and indicators one by one. Likert 5-level scoring method will be adopted for the importance score, and 1-5 points will be assigned according to "not important" to "very important". Modifications, additions or other comments on indicators will be recorded in the expert opinion column. 3) Pairwise comparison of indicators at all levels in the third round of expert letter questionnaire was carried out, and the pairwise comparative importance of each indicator was assigned by the 9-level scale of analytic Hierarchy Process (AHP). Matrix judgment and weight were determined according to the expert evaluation results. Determine the final VTE risk score.
Lower extremity venous ultrasound was performed on more than 1000 patients to obtain the current incidence of VTE among hospitalized patients in the community.
Blood samples were collected from more than 1000 patients, and blood samples from hospitalized patients were collected to determine coagulation function indexes, including prothrombin time, fibrinogen, partial thromboplastin time, thrombin time, fibrin degradation products, D-D dimer, and coagulation active factors.
- Conditions
- Venous Thromboembolism
- Keywords
- Venous Thromboembolism, Community hospitalization
- Medical subject headings
- Venous Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity venous ultrasound VTE event
Both lower limb venous B-ultrasonography will be performed on the patients to examine whether the patient has VTE event
Measured: This is a cross-sectional study, patients will be examined Day0 when incorporated into study
Secondary outcomes (1)
D-Dimer D-Dimer D-Dimer D-Dimer level
Indicators of coagulation function in patients, D-D dimer will be assayed to be the outcome
Measured: This is a cross-sectional study, patients will be examined Day0 when incorporated into study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start10 Oct 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Dec 2024 (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 RenJi 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-chun Gu, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168331
- Sponsor's protocol ID
- IIT-2023-0216
- Acronym
- COMET
- Status last verified
- Dec 2023
- First submitted
- 31 Oct 2023
- Last updated
- 13 Dec 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Community Inpatient Thromboembolism: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06168331
- Acronym / sponsor ID
- COMET / IIT-2023-0216
- Conditions
- Venous Thromboembolism
- Keywords
- Venous Thromboembolism, Community hospitalization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,152 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Dec 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.
This study is a multicenter cross-sectional study conducted at 20 centers. Data of existing inpatients in 20 community hospitals were collected. Information collected included demographic, co-morbidities, co-medication, laboratory tests, imaging tests, and anticoagulant use. Based on Caprini, Padua, Khorana and PAPT rating tables, VTE risk assessment was carried out for inpatients from 20 community hospitals, and VTE risk stratification of patients and prevention of high-risk VTE patients were analyzed. Blood samples of inpatients were collected to determine coagulation function indicators. VTE screening was performed on hospitalized patients using color Doppler ultrasound to determine the incidence of VTE in community hospitalized patients. On this basis, the predictive efficacy of different VTE risk scores on community hospitalized patients was compared, and a new VTE risk score conforming to community hospitalized patients was constructed.
Detailed description
This study was a prospective, multicenter, observational cohort study conducted in a cross-section of 20 eligible community hospitals.
Data of existing inpatients in 20 community hospitals were collected. Information collected included demographic, co-morbidities, co-medication, laboratory tests, imaging tests, and anticoagulant use. Inpatients from 20 community hospitals were evaluated for VTE risk by integrating scores such as Caprini, Padua, Khorana and PAPT, and their ability to perform activities of daily living was also evaluated. The stratification of VTE risk and the prevention of VTE in high-risk patients were analyzed, and the efficacy of different VTE risk scores in predicting VTE in community inpatients was compared. VTE risk score was constructed by Delphi method to simplify the clinical VTE evaluation process.
Delphi method was used to construct a VTE risk scoring process: 1) This study initially proposed several VTE risk indicators such as age, length of stay and score of autonomous activity ability through literature review. After analysis, discussion and rectification, the research team members screened the indicators according to the construction principles of the indicator system, and finally preliminatively determined the level and quantity of sensitive indicators. 2) Design expert letter questionnaire: This study plans to conduct a total of 3 rounds of letter questionnaire, which will be distributed and recovered by face-to-face presentation or email. 15 clinical experts with senior titles who have worked in VTE related research fields for more than 10 years, including clinicians, clinical pharmacists and nurses, etc., will be invited. Experts will evaluate all levels and indicators one by one. Likert 5-level scoring method will be adopted for the importance score, and 1-5 points will be assigned according to "not important" to "very important". Modifications, additions or other comments on indicators will be recorded in the expert opinion column. 3) Pairwise comparison of indicators at all levels in the third round of expert letter questionnaire was carried out, and the pairwise comparative importance of each indicator was assigned by the 9-level scale of analytic Hierarchy Process (AHP). Matrix judgment and weight were determined according to the expert evaluation results. Determine the final VTE risk score.
Lower extremity venous ultrasound was performed on more than 1000 patients to obtain the current incidence of VTE among hospitalized patients in the community.
Blood samples were collected from more than 1000 patients, and blood samples from hospitalized patients were collected to determine coagulation function indexes, including prothrombin time, fibrinogen, partial thromboplastin time, thrombin time, fibrin degradation products, D-D dimer, and coagulation active factors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Inpatients from 20 community health service centers in Shanghai.
Key inclusion criteria (2 listed)
- Inpatients in community service centers
Key exclusion criteria (2 listed)
- Outpatients in community service centers
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
Lower extremity venous ultrasound VTE event
Time frame: This is a cross-sectional study, patients will be examined Day0 when incorporated into study
Both lower limb venous B-ultrasonography will be performed on the patients to examine whether the patient has VTE event
1 secondary outcome
D-Dimer D-Dimer D-Dimer D-Dimer level
Time frame: This is a cross-sectional study, patients will be examined Day0 when incorporated into study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
2 sites 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 RenJi Hospital at 2 sites 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 2 inclusion and 2 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 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Meng Hu, PhD (+86 15000090636, humeng@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity venous ultrasound VTE event (time frame: This is a cross-sectional study, patients will be examined Day0 when incorporated into study). 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 13 Dec 2023.