Prognostic Value of Capillary Lactatemia in Potentially Severe Polytrauma Patients

NCT06969404 | Recruiting

• 1 other identifier: 24-AOI-05
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 3

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.

Conditions

Polytrauma

Outcome Measures

Primary Outcomes (2)

• lactemie value H0

  dosage of capillary lactemia in mmol/L

  at inclusion

• lactemie value H6

  dosage of capillary lactemia in mmol/L

  6 hours

Study Arms (1)

polytrauma patient

OTHER

capillary blood sampling

Biological: capillary blood sampling

Interventions

capillary blood sampling BIOLOGICAL

capillary blood sampling during the hospital transfert

polytrauma patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (3)

Antibes Hospital

Antibes, 06400, France

NOT YET RECRUITING

Cannes hospital

Cannes, 06000, France

NOT YET RECRUITING

Nice University Hospital

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Marta FERNANDES FEIRRERA, PH

CONTACT

0629847289; fernandes-feirrera.m@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 13, 2025
• Study Start: February 7, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)