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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