- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03293420
Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early (PRECOCE TC)
Observational retrospective study that included all patients meeting the inclusion criteria from 1st January 2014 to 31st December 2015.
The objective of the study is to describe and compare two populations of patients with severe traumatic head injury arriving under sedation in the Department in whom the sedation was not continued.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Dijon, France
- CHU Dijon Bourgogne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with traumatic head injuring arriving in the Neurosurgery and Traumatologic Intensive Care Unit under sedation
Exclusion Criteria:
- Brain death within the 48h following admission,
- Stroke leading to the traumatic head injury,
- Death within the 24h following admission,
- Patients not under sedation on admission to the unit,
- Non-sedated patients transferred directly to the operating theatre
- Traumatic brain injury in patients presenting chronic sub-dural haematoma,
- Continued sedation (> 15h) in the ICU.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Motor score
Time Frame: At baseline
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At baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LITTEL-GIRARD 2016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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