- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01938885
Hepatic Pseudoaneurysms After Trauma
September 17, 2013 updated by: Lene Osterballe, Rigshospitalet, Denmark
Hepatic Pseudoaneurysms After Conservatively Managed Liver Injuries
Hepatic pseudoaneurysm (HPA) is a rare complication after liver trauma, yet it is potentially fatal, as it can lead to sudden severe haemorrhage.
The risk of developing posttraumatic hepatic pseudoaneurysm is one of the reasons why some trauma centres do follow-up CT of patients with liver injuries to take the therapeutic consequence.
The aim of this study was to investigate the occurrence of HPA post liver trauma.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
238
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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Copenhagen, Denmark
- Rigshospitalet
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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
3 years to 77 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients conservatively managed and radiologically followed-up after liver injury, admitted Trauma Centre at the University hospital of Copenhagen, Rigshospitalet from January 2000 to December 2010.
Description
Inclusion Criteria:
- conservatively managed liver trauma patients with follow-up CT or US
Exclusion Criteria:
- patients who underwent laparotomy because of other intra-abdominal injuries
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and nature of hepatic pseudoaneurysm after hepatic trauma
Time Frame: 2000-2010
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All admitted and conservatively treated patients with sustained lever injury due to trauma from 2000-2010 were reviewed in order to investigate the incidence and nature of hepatic pseudoaneurysms after liver trauma
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2000-2010
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lene Osterballe, MD, Rigshospitalet, Denmark
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
October 1, 2011
Primary Completion (ACTUAL)
June 1, 2012
Study Completion (ACTUAL)
June 1, 2012
Study Registration Dates
First Submitted
September 5, 2013
First Submitted That Met QC Criteria
September 5, 2013
First Posted (ESTIMATE)
September 10, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
September 18, 2013
Last Update Submitted That Met QC Criteria
September 17, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lene Osterballe
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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