Traumatic Brain Injury Clinical Trial
Official title:
Becoming Traumatic Brain Injured Patients at Day 7 of Their Trauma in Poitiers Emergency
NCT number | NCT04077268 |
Other study ID # | Distance |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 8, 2019 |
Est. completion date | August 15, 2019 |
Verified date | May 2019 |
Source | Poitiers University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 110 |
Est. completion date | August 15, 2019 |
Est. primary completion date | August 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
France | CHU of POITIERS | Poitiers |
Lead Sponsor | Collaborator |
---|---|
Poitiers University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Becoming of traumatic brain injured patients: becoming classified in alive with or without sequelae or death, by using scale of GOS E | 7 days |
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