Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT06551350
Eligibility Criteria:
Inclusion Criteria :
* Between the 1st January 2023 and the 31th December 2023
* Regulated by SAMU 95 with suspected major trauma
* Sending an MCIU
* At least 1 Vittel criterion\*
Exclusion Criteria :
* Death on site
* Care by an MICU team outside the 95
* Minor patients and legal protection
* Transport refusals
* Vittel criterion :
• Physiological variables : Glasgow score \< 13 Systolic blood pressure \< 90 mmHg O2 saturation \< 90%
• Elements of kinetics : Ejection from a vehicle Other passenger killed in the same vehicle Fall \> 6 metres Victim thrown or crushed Overall assessment (deformation of the vehicle, estimated speed, absence of helmet, absence of seatbelt) Blast
• Anatomical lesions : Penetrating trauma to the head, neck, thorax, abdomen, pelvis, arm or thigh Flail chest Severe burn, smoke inhalation Pelvic fracture Suspected spinal cord injury Amputation of wrist, ankle or above Acute limb ischaemia
• Pre-hospital resuscitation : Assisted ventilation Filling \> 1000 ml with colloids Catecholamines Inflated shock-proof trousers
• Medical context (to be assessed) : Age \> 65 Cardiac or coronary insufficiency Respiratory insufficiency Pregnancy (2nd and 3rd trimesters) Blood crase disorders
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06551350
Study Brief:
Protocol Section:
NCT06551350