NCT06249646

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

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

January 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
Last Updated

February 8, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

January 23, 2024

Last Update Submit

January 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (1)

  • Investigate the management of CHVI following liver trauma.

    6 months

Eligibility Criteria

Age15 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • presence of liver trauma
  • age above 15 years old
  • a full contrast abdominal CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Location

MeSH Terms

Conditions

Aneurysm, False

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 8, 2024

Study Start

January 1, 2022

Primary Completion

October 31, 2022

Study Completion

March 31, 2023

Last Updated

February 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations