Venous ThromboembolismNCT04663477
Development and Validation of the Patient-completed Caprini Risk Score
An observational study of Venous Thromboembolism, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The investigators aimed to test the reliability and validity of the Chinese version of patient-completed CRS in hospitalized patients and to evaluate whether this form can be widely used in clinical practice instead of only health care workers' evaluation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- patient-completed Caprini Risk Score
- How many people
- 1,017 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2021
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The investigators will recruite nearly 500 inpatients from the surgical unit and nearly 500 inpatients from the medical unit between January 1 and December 31, 2019
Who may be able to join
- patients older than 18 years
- patients with first admission to the medical and surgical units within 24 hours
- willingness to participate in the study
Who cannot join
- patients with a diagnosis of PTE or DVT on admission
- patients with cognitive impairment
- inability to read or write
- patients with mental diseases
- patients with visual impairment
- refusal to cooperate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Frendship hospital
Beijing
Zhenguo Zhai, Ph D, 18611706133 ext. 86010, zhaizhenguo2011@126.com
About this study
Official title: Patient-Completed Caprini Risk Score for Venous Thromboembolism Risk Assessment Developed and Validated From 1017 Medical and Surgical Patients: a Diagnostic Study
The investigators aimed to test the reliability and validity of the Chinese version of patient-completed CRS in hospitalized patients and to evaluate whether this form can be widely used in clinical practice instead of only health care workers' evaluation.
- Conditions
- Venous Thromboembolism
- Being tested
- patient-completed Caprini Risk Score
- Keywords
- VTE risk, Caprini, Patient-complete, Validation
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient-completed Caprini Risk ScoreDiagnostic test
The participants will be asked to complete patient-completed Caprini Risk Score
| Study group | Role | What they receive |
|---|---|---|
| Trained nurse-completed CRS | Not described Receives: Diagnostic Test: patient-completed Caprini Risk Score | |
| Patient-completed CRS | Not described Receives: Diagnostic Test: patient-completed Caprini Risk Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Question-to-question agreement between patient-completed and nurse-completed CRS
The investigators will use kappa value to compare the question-to-question agreement level between nurse and patient-completed Caprini Risk Score
Measured: one year
Secondary outcomes (1)
Correlation and difference between the scores calculated by patient-completed and nurse-completed CRS
The Spearman correlation coefficient was used to measure the correlation and difference between patient-completed and nurse-completed CRS.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Jan 2019
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (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 China-Japan Friendship 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,017 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenguo Zhai,MD,PhD, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663477
- Sponsor's protocol ID
- VTE-CRS-study
- Status last verified
- Nov 2020
- First submitted
- 28 Nov 2020
- Last updated
- 11 Dec 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 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Completed Caprini Risk Score for Venous Thromboembolism Risk Assessment Developed and Validated From 1017 Medical and Surgical Patients: a Diagnostic Study
- ClinicalTrials.gov ID
- NCT04663477
- Acronym / sponsor ID
- VTE-CRS-study
- Conditions
- Venous Thromboembolism
- Keywords
- VTE risk, Caprini, Patient-complete, Validation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,017 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Dec 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.
The investigators aimed to test the reliability and validity of the Chinese version of patient-completed CRS in hospitalized patients and to evaluate whether this form can be widely used in clinical practice instead of only health care workers' evaluation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trained nurse-completed CRS | – | Diagnostic Test: patient-completed Caprini Risk Score |
| Patient-completed CRS | – | Diagnostic Test: patient-completed Caprini Risk Score |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators will recruite nearly 500 inpatients from the surgical unit and nearly 500 inpatients from the medical unit between January 1 and December 31, 2019
Key inclusion criteria (3 listed)
- patients older than 18 years
- patients with first admission to the medical and surgical units within 24 hours
- willingness to participate in the study
Key exclusion criteria (6 listed)
- patients with a diagnosis of PTE or DVT on admission
- patients with cognitive impairment
- inability to read or write
- patients with mental diseases
- patients with visual impairment
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 |
|---|---|---|
| patient-completed Caprini Risk ScoreThe participants will be asked to complete patient-completed Caprini Risk Score | Diagnostic test | Patient-completed CRS, Trained nurse-completed CRS |
Primary outcome
Question-to-question agreement between patient-completed and nurse-completed CRS
Time frame: one year
The investigators will use kappa value to compare the question-to-question agreement level between nurse and patient-completed Caprini Risk Score
1 secondary outcome
Correlation and difference between the scores calculated by patient-completed and nurse-completed CRS
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
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
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic 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.
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 China-Japan Friendship 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 3 inclusion and 6 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 11 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenguo Zhai, MD.PhD ((+86)010-84201000, zhaizhenguo2011@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Question-to-question agreement between patient-completed and nurse-completed CRS (time frame: one year). 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 11 Dec 2020.