Venous Thromboembolic DiseaseNCT05515549
Value of D-dimer Combined With Other Thrombus Molecular Markers in Risk Assessment of VTE in Hospitalized Patients
An observational study of Venous Thromboembolic Disease, run by Qianfoshan Hospital at 1 site in China.
Trial summary
The occurrence of VTE in hospital is an important cause of unexpected death of inpatients, and has become a serious problem faced by hospital managers and clinical medical staff.Under the target of "Improving the Standard Prevention Rate of Venous Thromboembolism" proposed in the "National Medical Quality and Safety… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolic Disease
- What is being tested?
- Venous blood was collected from patients under fasting state to detect the level of thrombus molecular markers
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2023to 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
- No healthy volunteers
- Adult, Older adult
Study population: From January 2023 to December 2024, 300 surgical patients with high risk of venous thrombosis admitted to the First Affiliated Hospital of Shandong First Medical University were selected as the study subjects
Who may be able to join
- Age ≥ 18 years
- Surgical inpatients
- Patients who were assessed as high-risk by venous thrombosis risk assessment after admission (caprini score ≥5)
- Did not receive anticoagulation or thrombolysis before admission
- Patients without chronic cardiovascular disease, autoimmune disease, malignant tumor and other diseases
- Patients without previous history of venous thrombosis of lower limbs
- The molecular markers of thrombus were detected routinely at admission
- The family members of the patients signed informed consent
Who cannot join
- Abnormal coagulation function due to blood disease or severe liver and kidney dysfunction
- Patients with major trauma or vegetative survival within 3 months
- Patients with long-term use of anticoagulant drugs, glucocorticoids and hemostatic drugs
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014
li li cao, 0531-89269891, qykyc309@163.com
hong wang
About this study
The occurrence of VTE in hospital is an important cause of unexpected death of inpatients, and has become a serious problem faced by hospital managers and clinical medical staff.Under the target of "Improving the Standard Prevention Rate of Venous Thromboembolism" proposed in the "National Medical Quality and Safety Improvement Goal in 2022", it is urgent to establish a highly sensitive VTE risk assessment and monitoring system.At present, VTE risk assessment scale is used for risk screening and monitoring in combination with D-dimer in clinical practice, but D-dimer has low specificity and poor sensitivity, which makes it impossible to accurately assess the risk of venous thrombosis.Therefore, it is very important to explore highly specific molecular markers of thrombosis for VTE risk assessment.This project will analyze the value of single or combined detection of different thrombus molecular markers in VTE risk assessment, establish the best VTE risk assessment scheme, improve the standardized prevention of VTE, realize the early intervention of VTE, truly achieve early detection, early prevention and early treatment, and effectively reduce the occurrence of VTE.
Read the detailed description
This project is intended to explore the specificity and reliability of single or combined detection of different thrombus molecular markers in venous thrombosis risk assessment by detecting and analyzing the levels of various thrombus molecular markers in VTE high-risk patients, so as to establish the best evaluation strategy for early identification of VTE high-risk patients, build the hospital VTE early warning management system, guide the clinical to formulate targeted graded intervention measures, and effectively reduce the occurrence of VTE. At the same time, it will provide support for the realization of "improving the standard prevention rate of venous thromboembolism" proposed in the national medical quality and safety improvement goal in 2022 and reducing medical risks.
- Conditions
- Venous Thromboembolic Disease
- Being tested
- Venous blood was collected from patients under fasting state to detect the level of thrombus molecular markers
- Keywords
- D-dimer, Thrombus Molecular Markers, venous thromboembolism risk assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood was collected from patients under fasting state to detect the level of thrombus molecular markersOther
The venous blood of the patients in fasting state was collected to detect the level of thrombus molecular markers. Color Doppler ultrasound was used as the "gold standard" to determine whether VTE occurred. According to the color Doppler ultrasound diagnosis results, the patients were divided into VTE group and non VTE group.
| Study group | Role | What they receive |
|---|---|---|
| Venous thrombosis group | The venous blood of the patients under fasting state was collected, and the level of thrombus molecular markers was detected. Color Doppler ultrasound was used as the "gold standard" to determine whether VTE occurred. Receives: Other: Venous blood was collected from patients under fasting state to detect the level of thrombus molecular markers | |
| Group without venous thrombosis | The venous blood of the patients under fasting state was collected, and the level of thrombus molecular markers was detected. Color Doppler ultrasound was used as the "gold standard" to determine whether VTE occurred. Receives: Other: Venous blood was collected from patients under fasting state to detect the level of thrombus molecular markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether venous thrombosis occurs
On the 13th day after the patient's admission, color Doppler ultrasound will be performed to determine whether the patient has venous thrombosis
Measured: On the 13th day after the patient's admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study startJan 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolic DiseaseStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Wang, Qianfoshan Hospital
- Investigators
- hong wang, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515549
- Sponsor's protocol ID
- Hong Wang
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of D-dimer Combined With Other Thrombus Molecular Markers in Risk Assessment of VTE in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT05515549
- Acronym / sponsor ID
- Hong Wang
- Conditions
- Venous Thromboembolic Disease
- Keywords
- D-dimer, Thrombus Molecular Markers, venous thromboembolism risk assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Aug 2022 (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 occurrence of VTE in hospital is an important cause of unexpected death of inpatients, and has become a serious problem faced by hospital managers and clinical medical staff.Under the target of "Improving the Standard Prevention Rate of Venous Thromboembolism" proposed in the "National Medical Quality and Safety Improvement Goal in 2022", it is urgent to establish a highly sensitive VTE risk assessment and monitoring system.At present, VTE risk assessment scale is used for risk screening and monitoring in combination with D-dimer in clinical practice, but D-dimer has low specificity and poor sensitivity, which makes it impossible to accurately assess the risk of venous thrombosis.Therefore, it is very important to explore highly specific molecular markers of thrombosis for VTE risk assessment.This project will analyze the value of single or combined detection of different thrombus molecular markers in VTE risk assessment, establish the best VTE risk assessment scheme, improve the standardized prevention of VTE, realize the early intervention of VTE, truly achieve early detection, early prevention and early treatment, and effectively reduce the occurrence of VTE.
Detailed description
This project is intended to explore the specificity and reliability of single or combined detection of different thrombus molecular markers in venous thrombosis risk assessment by detecting and analyzing the levels of various thrombus molecular markers in VTE high-risk patients, so as to establish the best evaluation strategy for early identification of VTE high-risk patients, build the hospital VTE early warning management system, guide the clinical to formulate targeted graded intervention measures, and effectively reduce the occurrence of VTE. At the same time, it will provide support for the realization of "improving the standard prevention rate of venous thromboembolism" proposed in the national medical quality and safety improvement goal in 2022 and reducing medical risks.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venous thrombosis group | – | Other: Venous blood was collected from patients under fasting state to detect the level of thrombus molecular markersThe venous blood of the patients under fasting state was collected, and the level of thrombus molecular markers was detected. Color Doppler ultrasound was used as the "gold standard" to determine whether VTE occurred. |
| Group without venous thrombosis | – | Other: Venous blood was collected from patients under fasting state to detect the level of thrombus molecular markersThe venous blood of the patients under fasting state was collected, and the level of thrombus molecular markers was detected. Color Doppler ultrasound was used as the "gold standard" to determine whether VTE occurred. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2023 to December 2024, 300 surgical patients with high risk of venous thrombosis admitted to the First Affiliated Hospital of Shandong First Medical University were selected as the study subjects
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Surgical inpatients
- Patients who were assessed as high-risk by venous thrombosis risk assessment after admission (caprini score ≥5)
- Did not receive anticoagulation or thrombolysis before admission
- Patients without chronic cardiovascular disease, autoimmune disease, malignant tumor and other diseases
Key exclusion criteria (3 listed)
- Abnormal coagulation function due to blood disease or severe liver and kidney dysfunction
- Patients with major trauma or vegetative survival within 3 months
- Patients with long-term use of anticoagulant drugs, glucocorticoids and hemostatic drugs
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 |
|---|---|---|
| Venous blood was collected from patients under fasting state to detect the level of thrombus molecular markersThe venous blood of the patients in fasting state was collected to detect the level of thrombus molecular markers. Color Doppler ultrasound was used as the "gold standard" to determine whether VTE occurred. According to the color Doppler ultrasound diagnosis results, the patients were divided into VTE group and non VTE group. | Other | Group without venous thrombosis, Venous thrombosis group |
Primary outcome
Whether venous thrombosis occurs
Time frame: On the 13th day after the patient's admission
On the 13th day after the patient's admission, color Doppler ultrasound will be performed to determine whether the patient has venous thrombosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Venous Thromboembolic Disease
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.
hong wang principal investigator
Shandong First 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 Thromboembolic Disease, run by Qianfoshan 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 8 inclusion and 3 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 25 Aug 2022. 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 hong wang, Master (13791123976, hongwang1971@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether venous thrombosis occurs (time frame: On the 13th day after the patient's admission). 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 25 Aug 2022.