PolytraumaCLATNCT06969404
Prognostic Value of Capillary Lactatemia in Potentially Severe Polytrauma Patients
A study testing capillary blood sampling in people with Polytrauma, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polytrauma
- What is being tested?
- capillary blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 3 sitesFrance
- Study dates
- 7 Feb 2026to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Antibes Hospital
Antibes, 06400
mikael FORTIER, 0497248170, mikael.fortier@ch-antibes.fr
fortier Mikael
- Not yet recruiting
Cannes hospital
Cannes, 06000
Elodie WINTER BUISSART, 0493697150, e.winter@ch-cannes.fr
elodie WINTER BUISSART
- Recruiting
Nice University Hospital
Nice, 06000
Fernandes-Feirrera Marta, 0629847289, frenandes-feirrera.m@chu-nice.fr
fernandes-feirrera Marta
About this study
Official title: Prognostic Value of Capillary Lactatemia in Potentially Severe Polytrauma in Pre-hospital Care
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
- Being tested
- capillary blood sampling
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capillary blood samplingBiological
capillary blood sampling during the hospital transfert
| Study group | Role | What they receive |
|---|---|---|
| polytrauma patient | Other | capillary blood sampling Receives: Biological: capillary blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
lactemie value H0
dosage of capillary lactemia in mmol/L
Measured: at inclusion
lactemie value H6
dosage of capillary lactemia in mmol/L
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start7 Feb 2026
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolytraumaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969404
- Sponsor's protocol ID
- 24-AOI-05
- Acronym
- CLAT
- Status last verified
- Mar 2026
- First submitted
- 2 May 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Capillary Lactatemia in Potentially Severe Polytrauma in Pre-hospital Care
- ClinicalTrials.gov ID
- NCT06969404
- Acronym / sponsor ID
- CLAT / 24-AOI-05
- Conditions
- Polytrauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 7 Feb 2026 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| polytrauma patient | Other | Biological: capillary blood samplingcapillary blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capillary blood samplingcapillary blood sampling during the hospital transfert | Biological | polytrauma patient |
Primary outcome
lactemie value H0
Time frame: at inclusion
dosage of capillary lactemia in mmol/L
lactemie value H6
Time frame: 6 hours
dosage of capillary lactemia in mmol/L
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capillary blood sampling in people with Polytrauma, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta FERNANDES FEIRRERA, PH (0629847289, fernandes-feirrera.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lactemie value H0 (time frame: at inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.