ClinicalTrials.gg
CompletedNCT03293420PRECOCE TCUpdated Sep 26, 2017

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

An observational study in Traumatic Head Injury, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-26.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
61
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 36 studies in Craniocerebral Trauma with a site in France — 6 open to participants now, 6 under way, none of them phase 3. Craniocerebral Trauma · France.

Enrollment
16th of 21
61 · median 130
Started
2016
with 1 other
Observational
21 of 36
4 open now
Registered
18th of 36
by date
Lead sponsor
1 of 36
Centre Hospitalier Universitaire Dijon

Among the 36 studies in Craniocerebral Trauma with a site in France, this one is the 16th largest by enrollment of the 21 observational ones that give a count, is one of 2 that started in 2016, is one of 21 observational ones, and was the 18th registered.

Craniocerebral Trauma

253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.

Browse Craniocerebral Trauma studies →

Open to participants now

6 of the 36 studies in Craniocerebral Trauma with a site in France are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 25 Craniocerebral Trauma studies recruiting now, 8 (32%) set no upper age limit and 14 (56%) stop at 75 or younger; 8 take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 36 studies in Craniocerebral Trauma with a site in France, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Traumatic Head Injury

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with traumatic head injury

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
61 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Motor score

    Time frame: At baseline

07

Study locations

1 site
  • CHU Dijon Bourgogne
    Dijon, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2016 to primary completion in Dec 2016, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2017
First posted
Sep 26, 2017
StartActual
May 2016
Primary completionActual
Dec 2016
CompletionActual
Dec 2016
Last update
Sep 26, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03293420
Responsible party
Sponsor
First posted
Sep 26, 2017
Start date
May 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Sep 26, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion