Hepatic InjuryNCT06249646
Contained Hepatic Vascular Injuries Following Liver Trauma
An observational study of Hepatic Injury and Liver Injury, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Hepatic Injury, Liver Injury, Pseudoaneurysm
- How many people
- 318 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 31 Mar 2023
- 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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: Liver trauma was identified on post-injury imaging evaluation or operative exploration. Admission following the trauma could either be directly from the trauma location or be a transfer from another regional hospital. Upon admission, if the patient was stable or stabilized following intensive care management, a contrast full-body CT scan was performed. Non-operative management was the primary treatment when possible. If the patient was unstable, primary surgical management was required. Surgical management could include sole exploration, hemostatic techniques, hepatic packing, drainage, or hepatectomy. If the investigators performed a damage control laparotomy with perihepatic packing, a second surgery was performed for definitive treatment after 24-48 h. In such cases, a contrast full-body CT scan was performed after the surgery. If a CT scan was not performed in the first 24 hours, the patient was not included in this study.
Who may be able to join
- presence of liver trauma
- age above 15 years old
- a full contrast abdominal CT
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hepatic Injury, Liver Injury, Pseudoaneurysm
- Medical subject headings
- Aneurysm, False
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a % of CHVI on the initial or the follow-up Chest-Thorax scans.
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
Measured: 6 months
Secondary outcomes (1)
Investigate the management of CHVI following liver trauma.
size in millimeters of pseudoaneurym conducting to angio-embolization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Jan 2022
- Primary completion31 Oct 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249646
- Sponsor's protocol ID
- 24Urgences01
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contained Hepatic Vascular Injuries Following Liver Trauma: a Retrospective Monocentric Study and Review of the Literature
- ClinicalTrials.gov ID
- NCT06249646
- Acronym / sponsor ID
- 24Urgences01
- Conditions
- Hepatic Injury, Liver Injury, Pseudoaneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 8 Feb 2024 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Liver trauma was identified on post-injury imaging evaluation or operative exploration. Admission following the trauma could either be directly from the trauma location or be a transfer from another regional hospital. Upon admission, if the patient was stable or stabilized following intensive care management, a contrast full-body CT scan was performed. Non-operative management was the primary treatment when possible. If the patient was unstable, primary surgical management was required. Surgical management could include sole exploration, hemostatic techniques, hepatic packing, drainage, or hepatectomy. If the investigators performed a damage control laparotomy with perihepatic packing, a second surgery was performed for definitive treatment after 24-48 h. In such cases, a contrast full-body CT scan was performed after the surgery. If a CT scan was not performed in the first 24 hours, the patient was not included in this study.
Key inclusion criteria (3 listed)
- presence of liver trauma
- age above 15 years old
- a full contrast abdominal CT
Key exclusion criteria (0 listed)
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
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
1 secondary outcome
Investigate the management of CHVI following liver trauma.
Time frame: 6 months
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 8 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Hepatic Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruitingEarly Phase 1
Silymarin Versus N-Acetylcysteine as Protective Effect Against Anti-tuberculosis Drugs Induced Liver Injury.
Drug-Induced Acute Liver Injury, Tuberculosis (TB)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingObservational study
Microbiome and Enteric Signatures in Sepsis-associated Hepatorenal Injury
Sepsis, Acute Kidney Injury Due to Sepsis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepatic Injury and Liver Injury, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 3 inclusion and 0 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 8 Feb 2024. 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 France. 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?
Identification of a % of CHVI on the initial or the follow-up Chest-Thorax scans. (time frame: 6 months). 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 8 Feb 2024.