Prognostic Value of Capillary Lactatemia in Potentially Severe Polytrauma Patients

NCT ID: NCT06969404

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-15

Study Completion Date

2027-12-15

Brief Summary

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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

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Conditions

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Polytrauma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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polytrauma patient

capillary blood sampling

Group Type OTHER

capillary blood sampling

Intervention Type BIOLOGICAL

capillary blood sampling during the hospital transfert

Interventions

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capillary blood sampling

capillary blood sampling during the hospital transfert

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Antibes Hospital

Antibes, , France

Site Status

Cannes hospital

Cannes, , France

Site Status

Nice University Hospital

Nice, , France

Site Status

Countries

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France

Central Contacts

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Marta FERNANDES FEIRRERA, PH

Role: CONTACT

0629847289

Facility Contacts

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mikael FORTIER

Role: primary

0497248170

Elodie WINTER BUISSART

Role: primary

0493697150

Fernandes-Feirrera Marta

Role: primary

0629847289

Other Identifiers

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24-AOI-05

Identifier Type: -

Identifier Source: org_study_id

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