Prognostic Value of Capillary Lactatemia in Potentially Severe Polytrauma Patients

Not Applicable

Not yet recruiting

• Conditions: Polytrauma
• Interventions: Biological: capillary blood sampling

• Registration Number: NCT06969404
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

Nowadays, the tools available to assess the severity of a polytrauma patient in the pre-hospital setting (vital parameters, shock index, MGAP score, Vittel criteria) have their limitations and are sometimes subjective. To date, there are no objective, practical and reproducible tools for triaging these patients. Venous lactataemia also appears to be predictive of poor outcome in severe trauma. However, there are no studies in the literature on capillary lactataemia, which would indicate the potential severity of a polytrauma patient in the pre-hospital setting. However, it is an easily performed, risk-free assay, the results of which can be obtained rapidly at the scene of the accident. The aim of this project is to confirm that, like venous lactataemia, capillary lactataemia can be useful in the pre-hospital phase for predicting a patient's poor outcome. Incorporating this assay into the assessment of potentially severe polytrauma patients in the pre-hospital phase could improve the predictive value of clinical and contextual data and thus enable better referral and management of these patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-05
• Study First Posted: 2025-05-13
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Study Start: 2025-06-15
• Primary Completion: 2027-06-15
• Study Completion: 2027-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

• Patient over 18 years of age

• Presenting a potentially serious pre-hospital trauma defined by:

  o A road accident or a fall of more than 2 metres

• Requiring the dispatch of a SMUR 06 team (mobile emergency and resuscitation service)

• And transferred to an emergency facility in the Alpes Maritimes with medical assistance.

• Consent signed (by the patient or a relative) after the event if it is not possible to sign immediately.

• Pregnant women may also take part in the study without any risk to themselves or their child.

Exclusion Criteria

• Patients with isolated peripheral limb trauma (wrist, elbow, knee, ankle, shoulder)
• Patients under legal protection (guardianship, curatorship)
• Patients in cardiorespiratory arrest when taken into care by the SMUR (emergency medical services)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
polytrauma patient	capillary blood sampling	capillary blood sampling

Primary Outcome Measures

Name	Time	Method
lactemie value H0	at inclusion	dosage of capillary lactemia in mmol/L
lactemie value H6	6 hours	dosage of capillary lactemia in mmol/L

Trial Locations

Locations (3)

Antibes Hospital; 🇫🇷 Antibes, France

Cannes hospital; 🇫🇷 Cannes, France

Nice University Hospital; 🇫🇷 Nice, France