- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05487066
Efficacy of ICU-VTE Scale in ICU Patients
Efficacy of ICU-VTE Scale in Predicting Venous Thromboembolism in ICU Patients
Study Overview
Status
Conditions
Detailed Description
Venous thromboembolism (VTE) is a group of thromboembolic diseases including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE), which is a systemic disease caused by a combination of risk factors. The risk of venous thromboembolism can be greatly reduced by the preventive treatment of it in hospitalized patients according to their risk level. The common risk assessment tools for inpatient VTE include the Padua score for medical patients and the Caprini score for surgical patients, but there is no clinical basis for implementing risk assessment for critically ill patients. The question of how to perform VTE risk assessment in ICU patients to prevent and treat the occurrence of VTE is worth exploring.
This study was designed according to a prospective study method. Data and information were collected from the time the patients were admitted to the ICU to the time the patients were discharged from the ICU.There are three purposes for this study. First, to observe the predictive effect and evaluate the value of the ICU-VTE scoring scale in comprehensive ICU patients; Second, to compare the advantages and disadvantages of the ICU-VTE scoring tool with the Padua score (internal medicine) and Caprini score tool (surgery); To analyze the risk factors for VTE in comprehensive ICU patients and to optimize the VTE risk prediction model; Third, to look into the prevention and treatment of VTE in critically ill ICU patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hubei
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Wuhan, Hubei, China, 430014
- The Central Hospital of Wuhan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients age greater than or equal to 18 years;
- Patients or their family members agreed to the study and signed informed consent.
Exclusion Criteria:
- Patients admitted to ICU with VTE diagnosis or diagnosed with VTE within 24 hours of admission to ICU;
- Use the therapeutic dose of anticoagulation before admission to ICU or within 24 hours in ICU;
- Expected ICU stay of less than 48 hours;
- Patients cannot obtain imaging data to confirm the presence of VTE during ICU admission
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of VTE
Time Frame: 28-day
|
inhospital venous thromboembolism occurrence
|
28-day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
all-cause mortality
Time Frame: 28-day
|
Death from all causes during hospitalization
|
28-day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juan Li Zhang, Master, Intensive Care Unit, the Central Hospital of Wuhan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WHZXKYL2022-117
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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