NCT06983873

Brief Summary

The aim of the study is to evaluate the application of Canadian C-Spine rules adapted to pre-hospital settings in France in order to improve the appropriateness of cervical spine immobilisation, reduce unnecessary imaging examinations and optimise patient care pathways.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
50mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Jun 2030

First Submitted

Initial submission to the registry

May 6, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

May 6, 2025

Last Update Submit

April 29, 2026

Conditions

Neck InjuryPrehospital EmergencyNeck TraumaEmergency Medical Services

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients admitted to emergency service

    Proportion of patients admitted to emergency following pre-hospital management of the traumatic event.

    Day 1

Secondary Outcomes (10)

  • Proportion of patients with cervical spine trauma admitted to emergency departments for a reason other than cervical spine trauma

    Day 1

  • Rate of relevant management strategy

    14 days

  • Proportion of patients with cervical imagery at 14 days

    14 days

  • Proportion of patients with at least one consultation for neck pain

    30 days

  • Cost of patient care

    30 days

  • +5 more secondary outcomes

Study Arms (2)

CCRa

EXPERIMENTAL

Pre-hospital management follow the rules of CCRa for all patients included in all sites ranodmized in the CCRa arm

Behavioral: adapted Canadian C-Spine rules

Control

NO INTERVENTION

Patients included from all sites randomized in the control arm will be assessed according to standard practice

Interventions

adapted Canadian C-Spine rulesBEHAVIORAL

The CCRa are decision rules for pre-hospital cervical spine collar immobilization. They include three high-risk criteria indicating imaging, 5 low-risk criteria allowing assessment of cervical spine rotation, and finally the ability of patients to achieve limited active rotation. They have been designed and validated to avoid immobilization during transport to the emergency department without any significant cervical injury being missed.

CCRa

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PATIENTS
  • GCS 15
  • Stable (no organ failure, SBP ≥ 90 mmHg, DBP ≥ 65 mmHg, RF between 10 and 24 cycles/min)
  • Cooperative (calm and obedient to instructions)
  • Victim of a closed cervical spine trauma treated in the pre-hospital setting (fire brigade and/or Mobile Emergency and Resuscitation Service (SMUR)).
  • Recent trauma (\< 48 hours).
  • Care regulated by the Emergency Medical Service (SAMU).
  • Beneficiary of a social security scheme.
  • Who can be contacted by telephone
  • Have received oral and written information and have not objected to taking part in the study.
  • PROFESSIONAL
  • Age ≥ 18 years
  • Professional firefighter or EMS regulating doctor
  • Professional who has received training in the protocol and, in the case of the experimental group, in the CCRa rules
  • Fluency in French
  • +1 more criteria

You may not qualify if:

  • PATIENTS
  • Life-threatening organ damage
  • Cardiorespiratory arrest since the traumatic event in question
  • Polytrauma patient
  • Penetrating trauma or a supra-clavicular wound following a knife or firearm injury
  • Known spinal disease or previous spinal surgery (ankylosing spondylitis, rheumatic fever, spinal stenosis, cervical spine surgery).
  • Acute paralysis (paraplegia, tetraplegia, hemiplegia, hemiparesis or documented sensory or motor deficit)
  • Diagnosed osteogenesis imperfecta.
  • Patients not regulated by EMS or transported to a hospital not participating in the study
  • Pregnant or breast-feeding women
  • Known situation of deprivation of liberty (safeguard of justice), guardianship or curatorship
  • PROFESSIONALS
  • \- Persons referred to in articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g. minors, protected adults, persons deprived of their liberty, persons under guardianship, curatorship, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU Amiens-Picardie

Amiens, France

NOT YET RECRUITING

CHRU Besançon

Besançon, France

NOT YET RECRUITING

Centre Hospitalier Sud-Francilien

Corbeil-Essonnes, France

NOT YET RECRUITING

Hôpitaux La Rochelle Ré Aunis

La Rochelle, France

NOT YET RECRUITING

AP-HM Timone

Marseille, France

NOT YET RECRUITING

CHRU Nancy

Nancy, France

NOT YET RECRUITING

CHU Nice

Nice, France

NOT YET RECRUITING

CHU Poitiers

Poitiers, France

NOT YET RECRUITING

CHU Reims

Reims, France

NOT YET RECRUITING

CHU Rennes

Rennes, France

RECRUITING

CHU Toulouse

Toulouse, France

NOT YET RECRUITING

Centre hospitalier Bretagne Atlantique

Vannes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Neck Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • François Saget, Md

    CHU Rennes / Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Laure Gervais, PhD

CONTACT

2 99 28 25 91marie-laure.gervais@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 21, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

June 1, 2030

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial will be available, after the primary publication of the results, to any researchers who provide a methodologically sound proposal. Proposals should be directed to dri@chu-rennes.fr. To gain access, data requestors will need to sign a data access agreement; depending on the case, additional formalities may be required.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data availability after the primary publication of the results and until the database is deleted
Access Criteria
Any researchers who provide a methodologically sound proposal will be able to access the IPD ans supporting information. To gain access, data requestors will need to sign a data access agreement; depending on the case, additional formalities may be required.

Locations

FR(12)