Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome

NCT04058379 | Unknown DMC

• 1 other identifier: 38RC19.193
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

We assume that an early iterative automatic CT scan analysis (D0, D1 and D3) by different AI approaches will allow an early differentiation of the tissues evolution after TBI. Our objective is to couple theses scan profiles to a neurological evolution, measured by therapeutic intensity.

Conditions

Trauma, Brain

Outcome Measures

Primary Outcomes (1)

• Clinical evolution during first 7 days in ICU with therapeutic intensity level (TILsum)

  Composite criteria : Head position, depth, sort and objective of sedation, presence or absence of a CSF draining system, management of ventilation, presence or absence of a hyperosmolar therapy, management of body temperature, surgical intervention for intracranial hypertension.

  7 days after TBI

Secondary Outcomes (8)

• Mortality according to scan profiles

  28 days after TBI and 6 month after TBI

• Morbidity (consequences of the trauma) according to scan profiles

  28 days after TBI

• Morbidity (consequences of the trauma) according to scan profiles

  28 days after TBI

• Morbidity (consequences of the trauma) according to scan profiles

  28 days after TBI

• Morbidity (consequences of the trauma) according to scan profiles

  28 days after TBI

Study Arms (1)

CT scan

EXPERIMENTAL

During this study each patient will have 3 CT scans : D0, D1 and D3. A daily follow up during first seven days in ICU, then a follow up at D28 if still in hospital, and a phone call at M6 for neurological outcome

Radiation: CT scan

Interventions

CT scan RADIATION

3 ct scans : D0, D1 and D3

CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> or = 18 years old
• Closed TBI
• Primary admission in Grenoble University Hospital
• Initial CT scan with visible cerebral lesion rated at least 3 on abbreviated injury score (AIS)
• In ICU for an expected length of 48 hours
• Social security system affiliation

You may not qualify if:

• Life expectation \<48 hours
• In ICU for more than 24h
• Transferred from another hospital
• Patients corresponding to articles L1121-5, L1121-6, L1121-7, L1121-8 (under legal protection) of French Public Health Code

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, France

Location

Related Publications (1)

• Brossard C, Greze J, de Busschere JA, Attye A, Richard M, Tornior FD, Acquitter C, Payen JF, Barbier EL, Bouzat P, Lemasson B. Prediction of therapeutic intensity level from automatic multiclass segmentation of traumatic brain injury lesions on CT-scans. Sci Rep. 2023 Nov 17;13(1):20155. doi: 10.1038/s41598-023-46945-9.

  PMID: 37978266 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Pierre BOUZAT

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: August 15, 2019
• Study Start: January 1, 2020
• Primary Completion: April 12, 2021
• Study Completion: October 12, 2021
• Last Updated: April 28, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)