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RecruitingNCT06969404CLATUpdated Mar 30, 2026

Prognostic Value of Capillary Lactatemia in Potentially Severe Polytrauma Patients

An interventional study of capillary blood sampling in Polytrauma, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
550
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Polytrauma

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
550 participants (estimated)

Study arms

  • Other
    polytrauma patient

    capillary blood sampling

    Biological: capillary blood sampling

Interventions

  • Biologicalcapillary blood sampling

    capillary blood sampling during the hospital transfert

05

What researchers measure

Primary outcomes

  1. lactemie value H0

    dosage of capillary lactemia in mmol/L

    Time frame: at inclusion

  2. lactemie value H6

    dosage of capillary lactemia in mmol/L

    Time frame: 6 hours

06

Study locations

1 of 3 sites recruiting
  • Antibes Hospital
    Antibes, 06400, France
    Not yet recruiting
  • Cannes hospital
    Cannes, 06000, France
    • Elodie WINTER BUISSART · Contact · e.winter@ch-cannes.fr · 0493697150
    • elodie WINTER BUISSART · Principal investigator
    Not yet recruiting
  • Nice University Hospital
    Nice, 06000, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06969404
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
May 13, 2025
Start date
Feb 7, 2026
Primary completion
Jun 15, 2027 (estimated)
Completion
Dec 15, 2027 (estimated)
Last update
Mar 30, 2026

Study contacts

Marta FERNANDES FEIRRERA, PH
Contact
fernandes-feirrera.m@chu-nice.fr
0629847289

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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