Venous ThromboembolismVTEHNCT02213978
A Clinical Cohort Study of Safety and Effectiveness of Venous Thromboembolism Prophylaxis in Critical Ill Patients
An observational study of Venous Thromboembolism and Hemorrhage, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
The purpose of this study is to analyze the effect of the prophylaxis of venous thromboembolism in the critical ill patients, and at the same time, to find out the risk of venous thromboembolism and hemorrhage events occurred under the prophylaxis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Hemorrhage
- How many people
- 1,114 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Dec 2021
- How long will I take part?
- 2 Weeks
- 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: the critical ill patients in ICUs
Who may be able to join
- all the patients in ICUs estimated time in ICU mare than 48h
Who cannot join
- estimated time in ICU less than 48h refused to attend
Trial locations and contacts
1 site in 1 country.
China1 site
Department of respiratory and critical care medicine,Beijing Chao-yang Hospital
Beijing, Beijing Municipality, 100020
About this study
The purpose of this study is to analyze the effect of the prophylaxis of venous thromboembolism in the critical ill patients, and at the same time, to find out the risk of venous thromboembolism and hemorrhage events occurred under the prophylaxis.
- Conditions
- Venous Thromboembolism, Hemorrhage
- Medical subject headings
- Venous Thromboembolism, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of venous thromboembolism under the thromboprophylaxis in critical ill patients
at the same time, to analyze the risk factor of the occurrence of venous thromboembolism despite of thromboprophylaxis
Measured: 2 weeks
Secondary outcomes (1)
the incidence of bleeding events under thromboprophylaxis in critical ill patients
at the same time, to analyze the risk factors of bleeding in critical ill patients who receive thromboprophylaxis
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Beijing Chao Yang 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
- Prospective
- Enrolment
- 1,114 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Tang, Beijing Chao Yang Hospital
- Investigators
- Xiao Tang, MD, Principal investigator, Beijing Chao-Yang Hospital,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213978
- Sponsor's protocol ID
- ICU-VTE-2014
- Acronym
- VTEH
- Status last verified
- Jan 2022
- First submitted
- 7 Aug 2014
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lyu WR, Tang X, Jin Y, Wang R, Li XY, Li Y, Zhang CY, Zhao W, Tong ZH, Sun B. Hemorrhages and risk factors in patients undergoing thromboprophylaxis in a respiratory critical care unit: a secondary data analysis of a cohort study. J Intensive Care. 2024 Oct 29;12(1):43. doi: 10.1186/s40560-024-00756-w.
PubMed 39473017Tang X, Lyu WR, Jin Y, Wang R, Li XY, Li Y, Zhang CY, Zhao W, Tong ZH, Sun B. Modern thromboprophylaxis protocol based on guidelines applied in a respiratory intensive care unit: a single-center prospective cohort study. Thromb J. 2022 Dec 12;20(1):76. doi: 10.1186/s12959-022-00439-2.
PubMed 36510234
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Cohort Study of Safety and Effectiveness of Venous Thromboembolism Prophylaxis in Critical Ill Patients
- ClinicalTrials.gov ID
- NCT02213978
- Acronym / sponsor ID
- VTEH / ICU-VTE-2014
- Conditions
- Venous Thromboembolism, Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,114 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 12 Aug 2014 (estimated)
- 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 purpose of this study is to analyze the effect of the prophylaxis of venous thromboembolism in the critical ill patients, and at the same time, to find out the risk of venous thromboembolism and hemorrhage events occurred under the prophylaxis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the critical ill patients in ICUs
Key inclusion criteria (1 listed)
- all the patients in ICUs estimated time in ICU mare than 48h
Key exclusion criteria (1 listed)
- estimated time in ICU less than 48h refused to attend
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
the incidence of venous thromboembolism under the thromboprophylaxis in critical ill patients
Time frame: 2 weeks
at the same time, to analyze the risk factor of the occurrence of venous thromboembolism despite of thromboprophylaxis
1 secondary outcome
the incidence of bleeding events under thromboprophylaxis in critical ill patients
Time frame: 2 weeks
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 11 Jan 2022.
- Derived from this study: PubMed 39473017Lyu WR, Tang X, Jin Y, Wang R, Li XY, Li Y, Zhang CY, Zhao W, Tong ZH, Sun B. Hemorrhages and risk factors in patients undergoing thromboprophylaxis in a respiratory critical care unit: a secondary data analysis of a cohort study. J Intensive Care. 2024 Oct 29;12(1):43. doi: 10.1186/s40560-024-00756-w.
- Derived from this study: PubMed 36510234Tang X, Lyu WR, Jin Y, Wang R, Li XY, Li Y, Zhang CY, Zhao W, Tong ZH, Sun B. Modern thromboprophylaxis protocol based on guidelines applied in a respiratory intensive care unit: a single-center prospective cohort study. Thromb J. 2022 Dec 12;20(1):76. doi: 10.1186/s12959-022-00439-2.
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.
Xiao Tang, MD principal investigator
Beijing Chao-Yang Hospital,China
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 and Hemorrhage, run by Beijing Chao Yang 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 11 Jan 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?
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?
the incidence of venous thromboembolism under the thromboprophylaxis in critical ill patients (time frame: 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 NCT02213978, which also lists 2 linked publications.
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 Jan 2022.