- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04077268
Becoming Traumatic Brain Injured Patients at Day 7 of Their Trauma
August 30, 2019 updated by: Poitiers University Hospital
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.
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 Overview
Study Type
Observational
Enrollment (Actual)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Poitiers, France, 86000
- CHU of POITIERS
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient add a head mild trauma and consult at the emergency of Poitiers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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7 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 8, 2019
Primary Completion (ACTUAL)
August 15, 2019
Study Completion (ACTUAL)
August 15, 2019
Study Registration Dates
First Submitted
May 28, 2019
First Submitted That Met QC Criteria
August 30, 2019
First Posted (ACTUAL)
September 4, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 4, 2019
Last Update Submitted That Met QC Criteria
August 30, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Distance
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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