NCT03293420

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

7 months

First QC Date

September 21, 2017

Last Update Submit

September 25, 2017

Conditions

Traumatic Head Injury

Outcome Measures

Primary Outcomes (1)

  • Motor score

    At baseline

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with traumatic head injury

You may qualify if:

  • \- Patients with traumatic head injuring arriving in the Neurosurgery and Traumatologic Intensive Care Unit under sedation

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, France

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2017

First Posted

September 26, 2017

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 26, 2017

Record last verified: 2017-09

Locations

FR(1)