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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2019
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


Recruitment information / eligibility

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).

Study Design


Intervention

Other:
GOS-E
Call at 7 days, patients add a brain trauma to know their sequeals

Locations

Country Name City State
France CHU of POITIERS Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

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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