Traumatic Brain InjuryNCT04077268
Becoming Traumatic Brain Injured Patients at Day 7 of Their Trauma
An observational study of Traumatic Brain Injury, run by Poitiers University Hospital at 1 site in France.
Trial summary
To study the future of traumatic brain injured patients at day 7 of their trauma Primary endpoint: Fate, classified as survival with or without sequelae, death. Use of the GOS-E scale to classify survival with or without sequelae. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- GOS-E
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2019to 15 Aug 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient add a head mild trauma and consult at the emergency of Poitiers
Who may be able to join
- Patient of both sexes, at least 18 years old,
- Patient with mild head trauma, Glasgow 13-15
- Patient without tutorship or curatorship
- Affiliation to social security
- No opposition of the patient or relatives to participation in the study.
Who cannot join
- Patient already included in this study
- Refusal to participate in this search
- Patient undergoing enhanced protection (persons deprived of liberty by a judicial or administrative decision, adults under legal protection).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Becoming Traumatic Brain Injured Patients at Day 7 of Their Trauma in Poitiers Emergency
To study the future of traumatic brain injured patients at day 7 of their trauma
Primary endpoint: Fate, classified as survival with or without sequelae, death. Use of the GOS-E scale to classify survival with or without sequelae. The collection of this scale will be done by telephone contact, 7 days of admission to the emergency room.
Read more
Secondary judgment criteria:
- Compendium of the realization of the CT / time respected between the TCL and the CT / Hospitalization / 2nd CT to realize at 24 hours in the patients treated by TAC or AAP
- Application of the recommendations of the French Society of Emergency Medicine 2012: Become 7 days of patients classified according to whether or not the recommendations, .
- Become TCL patients under AAP or TAC
- Number of reconsultation, rehospitalization, new imaging within 7 days after TCL
- Conditions
- Traumatic Brain Injury
- Being tested
- GOS-E
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOS-EOther
Call at 7 days, patients add a brain trauma to know their sequeals
What is being measured
The primary outcome is the main question the study is designed to answer.
Becoming of traumatic brain injured patients: becoming classified in alive with or without sequelae or death, by using scale of GOS E
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start8 Jul 2019
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077268
- Sponsor's protocol ID
- Distance
- Status last verified
- May 2019
- First submitted
- 28 May 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Becoming Traumatic Brain Injured Patients at Day 7 of Their Trauma in Poitiers Emergency
- ClinicalTrials.gov ID
- NCT04077268
- Acronym / sponsor ID
- Distance
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 4 Sep 2019 (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.
To study the future of traumatic brain injured patients at day 7 of their trauma
Primary endpoint: Fate, classified as survival with or without sequelae, death. Use of the GOS-E scale to classify survival with or without sequelae. The collection of this scale will be done by telephone contact, 7 days of admission to the emergency room.
Secondary judgment criteria:
- Compendium of the realization of the CT / time respected between the TCL and the CT / Hospitalization / 2nd CT to realize at 24 hours in the patients treated by TAC or AAP
- Application of the recommendations of the French Society of Emergency Medicine 2012: Become 7 days of patients classified according to whether or not the recommendations, .
- Become TCL patients under AAP or TAC
- Number of reconsultation, rehospitalization, new imaging within 7 days after TCL
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient add a head mild trauma and consult at the emergency of Poitiers
Key inclusion criteria (5 listed)
- Patient of both sexes, at least 18 years old,
- Patient with mild head trauma, Glasgow 13-15
- Patient without tutorship or curatorship
- Affiliation to social security
- No opposition of the patient or relatives to participation in the study.
Key exclusion criteria (3 listed)
- Patient already included in this study
- Refusal to participate in this search
- Patient undergoing enhanced protection (persons deprived of liberty by a judicial or administrative decision, adults under legal protection).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GOS-ECall at 7 days, patients add a brain trauma to know their sequeals | Other | – |
Primary outcome
Becoming of traumatic brain injured patients: becoming classified in alive with or without sequelae or death, by using scale of GOS E
Time frame: 7 days
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 4 Sep 2019.
- Individual participant dataSharing planned: No
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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 Brain Injury, run by Poitiers University Hospital 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 5 inclusion and 3 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 4 Sep 2019. 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?
Becoming of traumatic brain injured patients: becoming classified in alive with or without sequelae or death, by using scale of GOS E (time frame: 7 days). 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 4 Sep 2019.