- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06249646
Contained Hepatic Vascular Injuries Following Liver Trauma
Contained Hepatic Vascular Injuries Following Liver Trauma: a Retrospective Monocentric Study and Review of the Literature
Background: For thirty years, a major shift in the management of liver trauma has been seen. Contained hepatic vascular injuries (CHVI), including pseudo aneurysms and arteriovenous fistula, are often feared due to their risk of secondary bleeding. Nonetheless, knowledge of CHVI is scarce and no guidelines on their management have been set. The investigators aimed to validate the risk factors of CHVI, identify associated morbidities, and establish a management protocol.
Study Design: A retrospective study on 318 liver trauma from a level 1 trauma center over the last 15 years, comparing the presence or not of CHVI. Univarious and multivarious analyses were performed. A comparison of the management of CHVI was also performed.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Alpes Maritimes
-
Nice, Alpes Maritimes, France, 06000
- CHU de Nice
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- presence of liver trauma
- age above 15 years old
- a full contrast abdominal CT
Exclusion Criteria: none
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of a % of CHVI on the initial or the follow-up Chest-Thorax scans.
Time Frame: 6 months
|
A junior and a senior radiologist reviewed all initial and follow-up CT scans, blinded from the diagnostic. Contained hepatic vascular injuries (CHVI) was defined as Hepatic Pseudoaneurysm (HPA) and/or arterio-venous fistula (AVF), under the American Association for Surgery of Trauma (AAST) organ injury scale (2018 revision) for liver trauma definition: a contained focal collection of vascular contrast which decreases in attenuation on delayed phase images on contrast-enhanced CT |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Investigate the management of CHVI following liver trauma.
Time Frame: 6 months
|
size in millimeters of pseudoaneurym conducting to angio-embolization
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24Urgences01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Liver Injury
-
Xi'An Aolitai Pharmaceutical Technology Co LtdRecruitingDrug-Induced Liver Injury | Cholestatic Liver Injury | Mixed Liver InjuryChina
-
Drug Induced Liver Disease Study GroupActive, not recruitingLiver Injury | Liver Injury, Drug-InducedChina
-
Institute of Liver and Biliary Sciences, IndiaNot yet recruitingChronic Liver Disease | Drug Induced Liver InjuryIndia
-
University of Electronic Science and Technology...Chengdu Nuoen Biotechnologies, Inc.; Sichuan Cancer Hospital & InstituteUnknownComparative Study of Circulating microRNA Changes in Patients With Liver Injury and Healthy SubjectsLiver Failure | Drug-Induced Liver InjuryChina
-
University of North Carolina, Chapel HillCompletedDrug Induced Liver InjuryUnited States
-
Beijing 302 HospitalUnknownDrug-Induced Liver InjuryChina
-
Drug Induced Liver Disease Study GroupUnknownChronic Liver Disease | Acute Drug-induced Liver Injury
-
Institute of Liver and Biliary Sciences, IndiaTerminatedDrug Induced Liver InjuryIndia
-
Beijing 302 HospitalUnknownDrug-Induced Liver InjuryChina
-
Beijing 302 HospitalUnknownDrug-Induced Liver InjuryChina