- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01839266
Prognostic Factors for Acute Pulmonary Embolism in Critically Ill Patients
April 21, 2013 updated by: Yonsei University
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 120-752
- Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Chief of ICUs, Severance Hospital, Yonsei University Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
34 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with acute pulmonary embolism(PE) (diagnosed by CT) treated in the hospital with IV unfractionated heparin
Description
Inclusion Criteria:
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)
Exclusion Criteria:
- diagnosis was prior to arrivalor
- anticoagulation was contraindicated
- diagnosis was not confirmed by CT
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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acute PE survivor, acute PE nonsurvivor
acute PE survivor, acute PE nonsurvivor (in-hospital death)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prognostic factors of overall survival
Time Frame: change of acute pulmonary embolism(PE) for duration of hospital stay an expected average of 12 months
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In-hospital all-cause mortality with acute pulmonary embolism(PE) treated in the hospital with IV unfractionated heparin
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change of acute pulmonary embolism(PE) for duration of hospital stay an expected average of 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
April 1, 2013
First Submitted That Met QC Criteria
April 21, 2013
First Posted (Estimate)
April 24, 2013
Study Record Updates
Last Update Posted (Estimate)
April 24, 2013
Last Update Submitted That Met QC Criteria
April 21, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2013-0034
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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