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Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early (PRECOCE TC)

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ClinicalTrials.gov Identifier: NCT03293420
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

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.


Condition or disease
Traumatic Head Injury

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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early
Actual Study Start Date : May 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries




Primary Outcome Measures :
  1. Motor score [ Time Frame: At baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with traumatic head injury
Criteria

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.

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): NCT03293420


Locations
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France
CHU Dijon Bourgogne
Dijon, France
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03293420     History of Changes
Other Study ID Numbers: LITTEL-GIRARD 2016
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases