Development and Validation of a Prognostic Score for Early Death in Head Injury Patients.

NCT02861547 | Unknown

• 1 other identifier: MIREK 2015
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

Brief Summary

Traumatic brain injury (TBI) is a serious condition with high morbidity and mortality. The Glasgow score alone, assessed at the initial phase, is not enough to determine the prognosis. The aim of this study is to define and to evaluate a prognostic score for early death based on clinical and CT-scan findings in an observational retrospective derivation cohort of patients hospitalized for traumatic brain injury. This cohort will allow us to carry out a uni- and then multi-variate analysis so as to create a prognostic score for early death. We will subsequently test this score in a prospective validation cohort.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Early death

  Through the study completion up to 2 years

Study Arms (1)

Traumatic brain injury

Other: death

Interventions

death OTHER

Traumatic brain injury

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalisés pour traumatic brain injury

You may qualify if:

• Traumatic brain injury (PMSI code (Programme Médicalisation des Systèmes d'Information) S 06.70 and S 06.71) Age\>14 years Surviving more than 6h after the trauma Hospitalized in the traumatic brain injury intensive care unit and managed in accordance with international guidelines Who underwent a cerebral CT-scan

You may not qualify if:

• Ongoing treatment with anticoagulants or antiplatelets Pregnant women Persons without national health insurance cover Children less than 15 years old Under guardianship.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Death Domain

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Death Domain Superfamily; Protein Interaction Domains and Motifs; Protein Domains; Protein Structural Elements; Protein Conformation; Molecular Conformation; Molecular Structure; Biochemical Phenomena; Chemical Phenomena

Central Study Contacts

Sébastien MIREK

CONTACT

03.80.29.30.31; sebastien.mirek@chu-dijon.fr

Study Design

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

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 10, 2016
• Study Start: May 1, 2015
• Primary Completion: May 1, 2017
• Last Updated: August 10, 2016

Record last verified: 2016-07

Locations

FR (1)