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Recruiting NCT06969404

Prognostic Value of Capillary Lactatemia in Potentially Severe Polytrauma Patients

No phase Interventional Polytrauma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: capillary blood sampling.
Who it may be relevant to
Registry conditions: Polytrauma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prognostic Value of Capillary Lactatemia in Potentially Severe Polytrauma in Pre-hospital Care

Overview

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.

Interventions

  • Biological capillary blood sampling
    capillary blood sampling during the hospital transfert

Primary outcome measures

  • lactemie value H0 [Time frame: at inclusion]
  • lactemie value H6 [Time frame: 6 hours]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 3 centers
  • Antibes Hospital — Antibes
  • Cannes hospital — Cannes
  • Nice University Hospital — Nice

Identifiers

NCT: NCT06969404 · 24-AOI-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗