Traumatic Head InjuryPRECOCE TCNCT03293420
Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early
An observational study of Traumatic Head Injury, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Head Injury
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with traumatic head injury
Who may be able to join
- Patients with traumatic head injuring arriving in the Neurosurgery and Traumatologic Intensive Care Unit under sedation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Traumatic Head Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor score
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study startMay 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Head InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293420
- Sponsor's protocol ID
- LITTEL-GIRARD 2016
- Acronym
- PRECOCE TC
- Status last verified
- Sep 2017
- First submitted
- 21 Sep 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early
- ClinicalTrials.gov ID
- NCT03293420
- Acronym / sponsor ID
- PRECOCE TC / LITTEL-GIRARD 2016
- Conditions
- Traumatic Head Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with traumatic head injury
Key inclusion criteria (1 listed)
- Patients with traumatic head injuring arriving in the Neurosurgery and Traumatologic Intensive Care Unit under sedation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Motor score
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Head Injury, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor score (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.