NCT04077268

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

July 8, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
Last Updated

September 4, 2019

Status Verified

May 1, 2019

Enrollment Period

1 month

First QC Date

May 28, 2019

Last Update Submit

August 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Becoming of traumatic brain injured patients: becoming classified in alive with or without sequelae or death, by using scale of GOS E

    7 days

Interventions

GOS-EOTHER

Call at 7 days, patients add a brain trauma to know their sequeals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient add a head mild trauma and consult at the emergency of Poitiers

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU of POITIERS

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

September 4, 2019

Study Start

July 8, 2019

Primary Completion

August 15, 2019

Study Completion

August 15, 2019

Last Updated

September 4, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations