NCT01839266

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

1.1 years

First QC Date

April 1, 2013

Last Update Submit

April 21, 2013

Conditions

Keywords

acute PTE, prognostic factors

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

acute PE survivor, acute PE nonsurvivor

acute PE survivor, acute PE nonsurvivor (in-hospital death)

Eligibility Criteria

Age34 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with acute pulmonary embolism(PE) (diagnosed by CT) treated in the hospital with IV unfractionated heparin

You may qualify if:

  • 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)

You may not qualify if:

  • diagnosis was prior to arrivalor
  • anticoagulation was contraindicated
  • diagnosis was not confirmed by CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Chief of ICUs, Severance Hospital, Yonsei University Health System

Seoul, Seoul, 120-752, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2013

First Posted

April 24, 2013

Study Start

November 1, 2011

Primary Completion

December 1, 2012

Study Completion

April 1, 2013

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations