NCT02426255

Brief Summary

The purpose of this observational epidemiological study is to investigate the management and the complications associated with severe trauma. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
288mo left

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

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

Study Progress36%
Mar 2013Jan 2050

Study Start

First participant enrolled

March 29, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
34.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2050

Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

36.8 years

First QC Date

April 21, 2015

Last Update Submit

September 29, 2022

Conditions

Severe Trauma (With or Without Traumatic Brain Injury)

Keywords

Severe traumatraumatic Brain injuryHemorrhage

Outcome Measures

Primary Outcomes (1)

  • in ICU stay complications

    Nosocomial Infections (epidemiology, risk factors, antibiotic susceptibility of pathogens) Organ failures (incidence, risk factors) Bleeding, hemorrhage Intra-cranial hypertension, brain ischemia Mechanical ventilation weaning, extubation failure

    Within the 28 first days after ICU admission date

Secondary Outcomes (2)

  • Duration of mechanical ventilation

    in ICU (up to 90 days)

  • ICU length of stay

    in ICU (up to 90 days)

Other Outcomes (1)

  • Death

    in ICU (up to 90 days)

Study Arms (1)

ICU patients

Patients with severe trauma (with or without brain injury) or Patients with hemorrhagic shock Data concerning the ICU stay will be collected for these patients

Other: Collection of medical data from ICU patients

Interventions

Collection of medical data from ICU patientsOTHER

A code will be applied to each patient included. Medical data such as demography, Simplified Acute Physiological Score II (SAPS II), Sequential Organ Failure Assessment (SOFA), procedures and complications during ICU stay will be collected.

ICU patients

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in ICU for severe trauma

You may qualify if:

  • severe trauma
  • and/or traumatic brain injury
  • and/or hemorrhage

You may not qualify if:

  • Consent withdrawal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Angers University Hospital

Angers, 49000, France

RECRUITING

Nantes University Hospital

Nantes, 44093, France

RECRUITING

Poitiers University Hospital

Poitiers, 86000, France

RECRUITING

Rennes University Hospital

Rennes, 35000, France

RECRUITING

Tours University Hospital

Tours, 37000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, sera, peripheral blood mononuclear cells, RNA

MeSH Terms

Conditions

Wounds and InjuriesBrain Injuries, TraumaticHemorrhage

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karim ASEHNOUNE, PhD, MD

    STUDY CHAIR

Central Study Contacts

Karim Asehnoune, PhD, MD

CONTACT

02 40 08 73 80karim.asehnoune@chu-nantes.fr

Antoine Roquilly, MD

CONTACT

02 40 08 73 80antoine.roquilly@chu-nantes.fr

Study Design

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

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 24, 2015

Study Start

March 29, 2013

Primary Completion (Estimated)

January 1, 2050

Study Completion (Estimated)

January 1, 2050

Last Updated

September 30, 2022

Record last verified: 2022-09

Locations

FR(5)