Prognostic Factors for Acute Pulmonary Embolism in Critically Ill Patients

Acute Pulmonary Embolism (PE) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839266
• Other study ID #: 4-2013-0034
• Status: Completed
• Phase: N/A
• First received: April 1, 2013
• Last updated: April 21, 2013
• Start date: November 2011
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 34 Years and older

Eligibility

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:

1. diagnosis was prior to arrivalor

2. anticoagulation was contraindicated

3. diagnosis was not confirmed by CT

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Pulmonary Embolism (PE)
• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Chief of ICUs, Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prognostic factors of overall survival	In-hospital all-cause mortality with acute pulmonary embolism(PE) treated in the hospital with IV unfractionated heparin	change of acute pulmonary embolism(PE) for duration of hospital stay an expected average of 12 months	No