PseudoaneurysmNCT01938885
Hepatic Pseudoaneurysms After Trauma
An observational study of Pseudoaneurysm and Abdominal Trauma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 77 years
- Conditions the study is for
- Pseudoaneurysm, Abdominal Trauma
- How many people
- 238 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2011to Jun 2012
- 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 3 to 77 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- conservatively managed liver trauma patients with follow-up CT or US
Who cannot join
- patients who underwent laparotomy because of other intra-abdominal injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pseudoaneurysm, Abdominal Trauma
- Medical subject headings
- Aneurysm, False, Abdominal Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of hepatic pseudoaneurysm after hepatic trauma
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
Measured: 2000-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startOct 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudoaneurysmStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene Osterballe, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lene Osterballe, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938885
- Sponsor's protocol ID
- Lene Osterballe
- Status last verified
- Sep 2013
- First submitted
- 5 Sep 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Pseudoaneurysms After Conservatively Managed Liver Injuries
- ClinicalTrials.gov ID
- NCT01938885
- Acronym / sponsor ID
- Lene Osterballe
- Conditions
- Pseudoaneurysm, Abdominal Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Sep 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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- conservatively managed liver trauma patients with follow-up CT or US
Key exclusion criteria (1 listed)
- patients who underwent laparotomy because of other intra-abdominal injuries
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
Incidence and nature of hepatic pseudoaneurysm after hepatic trauma
Time frame: 2000-2010
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
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 18 Sep 2013.
Related trials for Pseudoaneurysm
Recruiting
Triple Branched Stent Graft System for Aortic Arch Lesions
Aortic Arch Aneurysm, Aortic Arch Pseudoaneurysm
Not yet recruiting
A Novel Wire-Reinforced Fenestration of a Hybrid Frozen Elephant Trunk Device for Supra-Aortic Branch Vessel Stenting During Aortic Arch Replacement
Aortic Aneurysm, Aortic Dissection
Recruiting
MBA Early Feasibility Study
Thoracic Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs)
Not yet recruitingObservational study
Renal Artery Pseudoaneurysm After PCNL
Artery Pseudoaneurysm After PCNL
Enrolling by invitation
Evaluation of the GORE® Ascending Stent Graft
Aortic Aneurysm, Thoracic, Pseudoaneurysm
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.
Lene Osterballe, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Pseudoaneurysm and Abdominal Trauma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 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 18 Sep 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 Denmark. 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?
Incidence and nature of hepatic pseudoaneurysm after hepatic trauma (time frame: 2000-2010). 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 18 Sep 2013.