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

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ClinicalTrials.gov Identifier: NCT02861547
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.


Condition or disease Intervention/treatment
Traumatic Brain Injury Other: death

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Study Type : Observational
Estimated Enrollment : 355 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Study Start Date : May 2015
Estimated Primary Completion Date : May 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Early death [ Time Frame: Through the study completion up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalisés pour traumatic brain injury
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861547


Contacts
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Contact: Sébastien MIREK 03.80.29.30.31 ext +33 sebastien.mirek@chu-dijon.fr

Locations
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France
CHU Dijon Bourgogne Recruiting
Dijon, France, 21079
Contact: Sébastien MIREK    03.80.29.30.31 ext +33    sebastien.mirek@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02861547    
Other Study ID Numbers: MIREK 2015
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System