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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02884999
Other study ID # APP
Secondary ID
Status Completed
Phase N/A
First received August 19, 2016
Last updated August 26, 2016
Start date May 2015
Est. completion date November 2015

Study information

Verified date August 2016
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority France: The Commission nationale de l’informatique et des libertés
Study type Observational

Clinical Trial Summary

This cohort study describes the epidemiology of trauma patients and their management in a French academic trauma center. It also aims to determine what recommendations from the European trauma guidelines is applied in routine.


Description:

Severe trauma is responsible for more than 5 millions of deaths annually worldwide. Haemorrhagic shock secondary to uncontrolled bleeding is the leading cause of preventable death in this population, making bleeding and coagulopathy treatment a key element of the early phase of trauma management. European trauma guidelines have been developed to help clinicians in severe trauma management and improve bleeding and coagulopathy treatment in this population. Investigating who these guidelines are followed in routine is crucial to identify opportunities to improve early management of bleeding severe trauma patients.


Recruitment information / eligibility

Status Completed
Enrollment 145
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Trauma patients with injury severity score equal to or higher than 16 year old admitted to the Brest academic trauma centre within the 24 hours following the trauma

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Locations

Country Name City State
France CHRU de BRest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients treated as per studied guidelines first 24 hours of trauma management No
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