Acute Pulmonary Embolism (PE)NCT01839266
Prognostic Factors for Acute Pulmonary Embolism in Critically Ill Patients
An observational study of Acute Pulmonary Embolism (PE), run by Yonsei University at 1 site in South Korea.
Trial summary
Acute pulmonary embolism (PE) is an important cause of in-hospital mortality and may be rapidly fatal if not diagnosed and treated. Despite recent advances in diagnostic and therapeutic modalities, it is still one of the important causes of hospital mortality. Read more about this study
- Who is it for?
- Ages 34 years and older
- Conditions the study is for
- Acute Pulmonary Embolism (PE)
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Apr 2013
- 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 34 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute pulmonary embolism(PE) (diagnosed by CT) treated in the hospital with IV unfractionated heparin
Who may be able to join
- patients admitted to the Severance Hospital, Yonsei University Health System with primary diagnosis of PE between January 2008 and December 2012. (diagnosed by CT and treated in the hospital with IV unfractionated heparin)
Who cannot join
- diagnosis was prior to arrivalor
- anticoagulation was contraindicated
- diagnosis was not confirmed by CT
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Chief of ICUs, Severance Hospital, Yonsei University Health System
Seoul, Seoul, 120-752
About this study
Acute pulmonary embolism (PE) is an important cause of in-hospital mortality and may be rapidly fatal if not diagnosed and treated. Despite recent advances in diagnostic and therapeutic modalities, it is still one of the important causes of hospital mortality. Previous several reports have described the variable outcome of patients with PE with reported mortality rate ranging from 8.1% (stable patients) to 25% (with cardiogenic shock) and 65% (post cardiopulmonary resuscitation). Nevertheless, there are no published studies from Korean hospitals that assessed the outcome of acute PE treated in the hospital with IV unfractionated heparin. We conducted this study to determine the outcome, risk factors, clinical characteristics and demographics of patients with acute PE and to identify possible demographic and clinical factors associated with prognosis.
- Conditions
- Acute Pulmonary Embolism (PE)
- Keywords
- acute PTE, prognostic factors
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 |
|---|---|---|
| acute PE survivor, acute PE nonsurvivor | acute PE survivor, acute PE nonsurvivor (in-hospital death) |
What is being measured
The primary outcome is the main question the study is designed to answer.
prognostic factors of overall survival
In-hospital all-cause mortality with acute pulmonary embolism(PE) treated in the hospital with IV unfractionated heparin
Measured: change of acute pulmonary embolism(PE) for duration of hospital stay an expected average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pulmonary Embolism (PE)Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 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
- NCT01839266
- Sponsor's protocol ID
- 4-2013-0034
- Status last verified
- Apr 2013
- First submitted
- 1 Apr 2013
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors for Acute Pulmonary Embolism in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01839266
- Acronym / sponsor ID
- 4-2013-0034
- Conditions
- Acute Pulmonary Embolism (PE)
- Keywords
- acute PTE, prognostic factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Apr 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.
Acute pulmonary embolism (PE) is an important cause of in-hospital mortality and may be rapidly fatal if not diagnosed and treated. Despite recent advances in diagnostic and therapeutic modalities, it is still one of the important causes of hospital mortality. Previous several reports have described the variable outcome of patients with PE with reported mortality rate ranging from 8.1% (stable patients) to 25% (with cardiogenic shock) and 65% (post cardiopulmonary resuscitation). Nevertheless, there are no published studies from Korean hospitals that assessed the outcome of acute PE treated in the hospital with IV unfractionated heparin. We conducted this study to determine the outcome, risk factors, clinical characteristics and demographics of patients with acute PE and to identify possible demographic and clinical factors associated with prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute PE survivor, acute PE nonsurvivor | – | –acute PE survivor, acute PE nonsurvivor (in-hospital death) |
Who may qualify
- Ages
- 34 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute pulmonary embolism(PE) (diagnosed by CT) treated in the hospital with IV unfractionated heparin
Key inclusion criteria (1 listed)
- patients admitted to the Severance Hospital, Yonsei University Health System with primary diagnosis of PE between January 2008 and December 2012. (diagnosed by CT and treated in the hospital with IV unfractionated heparin)
Key exclusion criteria (3 listed)
- diagnosis was prior to arrivalor
- anticoagulation was contraindicated
- diagnosis was not confirmed by CT
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
prognostic factors of overall survival
Time frame: change of acute pulmonary embolism(PE) for duration of hospital stay an expected average of 12 months
In-hospital all-cause mortality with acute pulmonary embolism(PE) treated in the hospital with IV unfractionated heparin
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 24 Apr 2013.
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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 Acute Pulmonary Embolism (PE), 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 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: finished, as of the sponsor's last update on 24 Apr 2013. 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?
prognostic factors of overall survival (time frame: change of acute pulmonary embolism(PE) for duration of hospital stay an expected average of 12 months). 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 24 Apr 2013.