Development and Validation of a Prognostic Score for Early Death in Head Injury Patients. (SCORE TC)

August 5, 2016 updated by: Centre Hospitalier Universitaire Dijon

Development and Validation of a Prognostic Score for Early Death in Head Injury Patients in the Traumatic Brain Injury Intensive Care Unit of Dijon CHU

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

355

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalisés pour traumatic brain injury

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Traumatic brain injury
Other: death

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Early death
Time Frame: Through the study completion up to 2 years
Through the study completion up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

August 5, 2016

First Submitted That Met QC Criteria

August 5, 2016

First Posted (Estimate)

August 10, 2016

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIREK 2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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