Traumatic Brain Injury Clinical Trial
— SCORE TCOfficial 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
| NCT number | NCT02861547 |
| Other study ID # | MIREK 2015 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | August 5, 2016 |
| Last updated | August 5, 2016 |
| Start date | May 2015 |
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.
| Status | Recruiting |
| Enrollment | 355 |
| Est. completion date | |
| Est. primary completion date | May 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 15 Years and older |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Dijon Bourgogne | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Early death | Through the study completion up to 2 years | No |
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