Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early

Traumatic Head Injury Clinical Trial

— PRECOCE TC  

Official title:

Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293420
• Other study ID #: LITTEL-GIRARD 2016
• Status: Completed
• Phase: N/A
• First received: September 21, 2017
• Last updated: September 25, 2017
• Start date: May 2016
• Est. completion date: December 2016

Study information

• Verified date: September 2017
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Traumatic Head Injury
• Wounds and Injuries

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor score		At baseline