Venous ThromboembolismNCT01851239
Venous Thromboembolism Prophylaxis in Medical and Surgical ICUs in a Single University Hospital
An observational study of Venous Thromboembolism, run by Yonsei University at 1 site in South Korea.
Trial summary
Venous thromboembolism(VTE) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. VTE often occurs in intensive care patients and there had been many efforts to prevent such complication. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Apr 2014
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ICU admitted patients who are indicated for VTE prophylaxis.
Who may be able to join
- ICU admitted patients
Who cannot join
- patients under 20 years old
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
Venous thromboembolism(VTE) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. VTE often occurs in intensive care patients and there had been many efforts to prevent such complication. The American College of Chest Physicians (ACCP) had published evidence-based clinical practice guideline for VTE prophylaxis.
This study focuses on how VTE prophylaxis is being performed in both medical and surgical ICUs in a single University hospital, and sees the differences in such prophylactic patterns.
- Conditions
- Venous Thromboembolism
- Keywords
- Venous Thromboembolism Prophylaxis, ICU
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| medical ICU inpatients | Not described | |
| surgical ICU inpatients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients prescribed with any measures of VTE prophylaxis in ICU
The object of this study is to see the percentage of ICU admitted patients prescribed with VTE prophylaxis, and analyze the adequacy of such prophylactic measure according to the international guideline. Moreover, difference between the VTE prophylaxis pattern of medical and surgical ICUs will also be seek for further analysis.
Measured: at the time of ICU admission an expected average of 5 months (When VTE prophylaxis for each patient is being ordered)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionApr 2014
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 Yonsei UniversityThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851239
- Sponsor's protocol ID
- 1-2013-0002
- Status last verified
- May 2014
- First submitted
- 25 Apr 2013
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thromboembolism Prophylaxis in Medical and Surgical ICUs in a Single University Hospital
- ClinicalTrials.gov ID
- NCT01851239
- Acronym / sponsor ID
- 1-2013-0002
- Conditions
- Venous Thromboembolism
- Keywords
- Venous Thromboembolism Prophylaxis, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 May 2013 (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.
Venous thromboembolism(VTE) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. VTE often occurs in intensive care patients and there had been many efforts to prevent such complication. The American College of Chest Physicians (ACCP) had published evidence-based clinical practice guideline for VTE prophylaxis.
This study focuses on how VTE prophylaxis is being performed in both medical and surgical ICUs in a single University hospital, and sees the differences in such prophylactic patterns.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medical ICU inpatients | – | – |
| surgical ICU inpatients | – | – |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ICU admitted patients who are indicated for VTE prophylaxis.
Key inclusion criteria (1 listed)
- ICU admitted patients
Key exclusion criteria (1 listed)
- patients under 20 years old
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
number of patients prescribed with any measures of VTE prophylaxis in ICU
Time frame: at the time of ICU admission an expected average of 5 months (When VTE prophylaxis for each patient is being ordered)
The object of this study is to see the percentage of ICU admitted patients prescribed with VTE prophylaxis, and analyze the adequacy of such prophylactic measure according to the international guideline. Moreover, difference between the VTE prophylaxis pattern of medical and surgical ICUs will also be seek for further analysis.
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 5 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Yonsei University at 1 site in South Korea.
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 5 May 2014. 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 South Korea. 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?
number of patients prescribed with any measures of VTE prophylaxis in ICU (time frame: at the time of ICU admission an expected average of 5 months (When VTE prophylaxis for each patient is being ordered)). 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 5 May 2014.