Prediction of Secondary Neurological Deterioration in Patients With Moderate Traumatic Brain Injury

NCT04854954 | Completed

• 1 other identifier: PREDICT-TCM (29BRC20. 0136)
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with moderate traumatic brain injury (mTBI) are 1,5 times more frequent than those with severe TBI and some of them will develop secondary neurologic deterioration (SND) within the first 7 days. However, identifying at risk patients of SND is still challenging. This study aimed to determine risk factors associated with SND after mTBI.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Secondary neurologic deterioration

  SND was defined either by a decrease in GCS or by a deterioration in neurologic status sufficient to warrant intervention like mechanical ventilation, transfer to the ICU or neurosurgical intervention

  Within 7 days after hospital admission

Eligibility Criteria

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

Study Population

All adults admitted in Brest hospital (ICU and wards) between 2015 and 2018 for moderate TB

You may qualify if:

• Adults
• Admitted in Brest hospital between 2015 and 2018 for moderate TBI, defined by Glasgow coma scale (GCS) score 9-13

You may not qualify if:

• Non consenting patients

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Related Publications (1)

• Aries P, Ognard J, Cadieu A, Degos V, Huet O. Secondary Neurologic Deterioration After Moderate Traumatic Brain Injury: Development of a Multivariable Prediction Model and Proposition of a Simple Triage Score. Anesth Analg. 2024 Jan 1;138(1):171-179. doi: 10.1213/ANE.0000000000006460. Epub 2023 Apr 25.

  PMID: 37097898 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 Design

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

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: February 3, 2021
• Primary Completion: February 22, 2021
• Study Completion: March 22, 2021
• Last Updated: April 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three months and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)