Trauma InjurySAMU-TRAUMASNCT06551350
Retrospective Assessment of Referral of a Major Trauma Patient
An observational study of Trauma Injury, run by Hôpital NOVO at 1 site in France.
Trial summary
The aim of this study is to find out whether major trauma patients from the Val d'Oise are referred to the appropriate trauma centre for their care and to assess the quality of triage within the Val d'Oise department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Data Collection
- How many people
- 461 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2024to May 2025
- Phase
- Observational
- 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
Study population: Patients regulated by SAMU 95 with suspected major trauma between the 1st January 2023 and the 31th December 2023.
Who may be able to join
- Between the 1st January 2023 and the 31th December 2023
- Regulated by SAMU 95 with suspected major trauma
- Sending an MCIU
- At least 1 Vittel criterion*
Who cannot join
- Death on site
- Care by an MICU team outside the 95
- Minor patients and legal protection
- Transport refusals
- Vittel criterion :
- Physiological variables : Glasgow score < 13 Systolic blood pressure < 90 mmHg O2 saturation < 90%
Show all 10Show fewer
- Elements of kinetics : Ejection from a vehicle Other passenger killed in the same vehicle Fall > 6 metres Victim thrown or crushed Overall assessment (deformation of the vehicle, estimated speed, absence of helmet, absence of seatbelt) Blast
- Anatomical lesions : Penetrating trauma to the head, neck, thorax, abdomen, pelvis, arm or thigh Flail chest Severe burn, smoke inhalation Pelvic fracture Suspected spinal cord injury Amputation of wrist, ankle or above Acute limb ischaemia
- Pre-hospital resuscitation : Assisted ventilation Filling > 1000 ml with colloids Catecholamines Inflated shock-proof trousers
- Medical context (to be assessed) : Age > 65 Cardiac or coronary insufficiency Respiratory insufficiency Pregnancy (2nd and 3rd trimesters) Blood crase disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Resuscitation Services (SAMU 95/SMUR) - Hôpital NOVO -Pontoise Site
Pontoise, 95300
Dr Fabrice LOUVET, +33 1 30 75 40 15, fabrice.louvet@ght-novo.fr
Pierre CHENEVIER, pierre.chenevier@aphp.fr
About this study
Official title: Retrospective Assessment of Referral of a Major Trauma Patient in Val-d'Oise
The aim of this study is to find out whether major trauma patients from the Val d'Oise are referred to the appropriate trauma centre for their care and to assess the quality of triage within the Val d'Oise department.
Read the detailed description
In France, the number of major trauma is estimated at between 15,000 and 20,000 per year. It is the leading cause of death in patients under the age of 40, and is a significant source of long-term dependency. Mortality from severe trauma varies depending on the region and the circumstances of the accident. Effective initial care and referral to specialist trauma centres are crucial to improving survival. Access to these centres must be guaranteed throughout France. Trauma centres play a central role in the management of serious trauma patients. They are classified by level, from level I to level III.
The triage process aims to direct the patient to the trauma centre with the appropriate level of care. The challenge is to send the "right patient to the right place at the right time". Over-triage and under-triage are two critical concepts in the management of trauma patients. Over-triage (patients considered to be more seriously injured than they really are) leads to excessive consumption of resources and increases waiting times for patients who really need a level I or II trauma centre. Under-triage (patients considered to be less seriously injured than they really are), is characterised by patients being referred to a trauma centre that is insufficiently equipped for their needs, compromises their chances of survival and recovery. In both cases, the loss of chance for the patient is real.
The aim of this study is to find out whether major trauma patients from the Val d'Oise are referred to the appropriate trauma centre for their care, and to assess the quality of triage within the Val d'Oise department.
- Conditions
- Trauma Injury
- Being tested
- Data Collection
- Keywords
- Major trauma, Mobile Intensive Care Unit (MCIU)
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
Collection of medical data from MICU intervention file and the medical records of patients at the destination hospital
What is being measured
The primary outcome is the main question the study is designed to answer.
Triage assessment of a major trauma patient
The criterion is the evaluation of the referral of the major trauma patient after post-Medics injury assessment into over, normo and under-triage
The over-triage patient is referred to a level I trauma centre with an Injury Severity Score (ISS) <16
The normo-triage patients are either referred to:
- a level 1 trauma centre with an ISS >15
- the local scanner and then to an intensive care unit at the scanner site
- in the emergency department and then to a surgical unit
- emergency with a return home afterwards
The under-triage patient is either referred to:
- the local scanner and then to a level 1 trauma centre
- initially emergency with hospitalisation in an intensive care or continuing care unit afterwards
Measured: At the end of the study, an average of 9 month
Secondary outcomes (7)
Assess if the intervention time is correlated with an under-triage
The correlation will be assessed by the proportion of patients under-triaged during the following hours:
- 7am to 9am
- From 6pm to 9pm
- From 9pm to 7am i.e. the ratio between the number of under-triaged patients and the number of major trauma patients treated during the defined time slots.
Measured: At the end of the study, an average of 9 month
Assess if presumed alcohol intoxication is correlated with a higher rate of under-triage
The correlation will be assessed by the proportion of patients under-triaged in patients with suspected alcohol intoxication. Presence of suspected alcohol intoxication assessed clinically i.e. the ratio between the number of under-triaged patients with suspected alcohol intoxication and the total number of major trauma patients
Measured: At the end of the study, an average of 9 month
Assess if deliberate toxic poisoning is correlated with a higher rate of under-triage
The correlation will be assessed by the proportion of patients under-triaged in patients with suspected deliberate toxic poisoning. Presence of deliberate toxic poisoning assessed clinically i.e. the ratio between the number of under-triaged patients with suspected deliberate toxic poisoning and the total number of major trauma patients
Measured: At the end of the study, an average of 9 month
Assess if the TRENAU grade is predictive in pre-hospital of an appropriate referral following an intra-hospital trauma assessment
The criterion will be assessed by the correlation between TRENAU grade and level of trauma centre for final admission :
TRENAU A in a level 1 trauma centre TRENAU B in a level 2 trauma centre TRENAU C in a level 3 trauma centre The TRENAU grade (Trauma System du Réseau Nord Alpin des Urgences) is used to classify major trauma patients into 3 categories (A, B and C) in the pre-hospital phase, so that they can be referred to the appropriate level of hospital
Measured: At the end of the study, an average of 9 month
Assess if the positive Shock-Index is predictive of an appropriate pre-hospital referral to a level 1 trauma centre
The criterion will be assessed by the number of patient with positive Shock-Index (≥ 0.9) at the time of MCIU care referred to a level 1 trauma centre (final admission)
Measured: At the end of the study, an average of 9 month
Assess if the positive Shock-Index ( ≥ 0.9 ) is predictive of an intra-hospital blood transfusion
The criterion will be assessed by the number of patient with positive Shock-Index (≥ 0.9) at the time of MCIU care and who have had an intra-hospital blood transfusion
Measured: At the end of the study, an average of 9 month
Assess if the MGAP is predictive of an appropriate referral following an intra-hospital trauma assessment
The evaluation criterion will be assessed as follow :
Number of patient with a MGAP between 23 and 29 and an final admission in a level 3 trauma centre Number of patient with a MGAP between 18 and 22 and an final admission in a level 2 trauma centre Number of patient with a MGAP < 18 and an final admission in a level 3 trauma centre The MGAP score (Mechansim, Glasgow, Age, Arterial pressure) can predict the risk of in-hospital death in trauma patients. Three risk groups have been defined: low (23-29 points), intermediate (18-22 points) and high (<18 points).
Measured: At the end of the study, an average of 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start18 Oct 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 461 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice LOUVET, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551350
- Sponsor's protocol ID
- CHRD0924
- Acronym
- SAMU-TRAUMAS
- Status last verified
- Dec 2024
- First submitted
- 9 Aug 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
MacKenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Frey KP, Egleston BL, Salkever DS, Scharfstein DO. A national evaluation of the effect of trauma-center care on mortality. N Engl J Med. 2006 Jan 26;354(4):366-78. doi: 10.1056/NEJMsa052049.
PubMed 16436768Haagsma JA, Graetz N, Bolliger I, Naghavi M, Higashi H, Mullany EC, Abera SF, Abraham JP, Adofo K, Alsharif U, Ameh EA, Ammar W, Antonio CA, Barrero LH, Bekele T, Bose D, Brazinova A, Catala-Lopez F, Dandona L, Dandona R, Dargan PI, De Leo D, Degenhardt L, Derrett S, Dharmaratne SD, Driscoll TR, Duan L, Petrovich Ermakov S, Farzadfar F, Feigin VL, Franklin RC, Gabbe B, Gosselin RA, Hafezi-Nejad N, Hamadeh RR, Hijar M, Hu G, Jayaraman SP, Jiang G, Khader YS, Khan EA, Krishnaswami S, Kulkarni C, Lecky FE, Leung R, Lunevicius R, Lyons RA, Majdan M, Mason-Jones AJ, Matzopoulos R, Meaney PA, Mekonnen W, Miller TR, Mock CN, Norman RE, Orozco R, Polinder S, Pourmalek F, Rahimi-Movaghar V, Refaat A, Rojas-Rueda D, Roy N, Schwebel DC, Shaheen A, Shahraz S, Skirbekk V, Soreide K, Soshnikov S, Stein DJ, Sykes BL, Tabb KM, Temesgen AM, Tenkorang EY, Theadom AM, Tran BX, Vasankari TJ, Vavilala MS, Vlassov VV, Woldeyohannes SM, Yip P, Yonemoto N, Younis MZ, Yu C, Murray CJ, Vos T. The global burden of injury: incidence, mortality, disability-adjusted life years and time trends from the Global Burden of Disease study 2013. Inj Prev. 2016 Feb;22(1):3-18. doi: 10.1136/injuryprev-2015-041616. Epub 2015 Dec 3.
PubMed 26635210Hirsch M, Carli P, Nizard R, Riou B, Baroudjian B, Baubet T, Chhor V, Chollet-Xemard C, Dantchev N, Fleury N, Fontaine JP, Yordanov Y, Raphael M, Burtz CP, Lafont A; health professionals of Assistance Publique-Hopitaux de Paris (APHP). The medical response to multisite terrorist attacks in Paris. Lancet. 2015 Dec 19;386(10012):2535-8. doi: 10.1016/S0140-6736(15)01063-6. Epub 2015 Nov 28. No abstract available.
PubMed 26628327Cotte J, Courjon F, Beaume S, Prunet B, Bordes J, N'Guyen C, Contargyris C, Lacroix G, Montcriol A, Kaiser E, Meaudre E. Vittel criteria for severe trauma triage: Characteristics of over-triage. Anaesth Crit Care Pain Med. 2016 Apr;35(2):87-92. doi: 10.1016/j.accpm.2015.06.013. Epub 2015 Dec 1.
PubMed 26592159Sartorius D, Le Manach Y, David JS, Rancurel E, Smail N, Thicoipe M, Wiel E, Ricard-Hibon A, Berthier F, Gueugniaud PY, Riou B. Mechanism, glasgow coma scale, age, and arterial pressure (MGAP): a new simple prehospital triage score to predict mortality in trauma patients. Crit Care Med. 2010 Mar;38(3):831-7. doi: 10.1097/CCM.0b013e3181cc4a67.
PubMed 20068467Liao TK, Ho CH, Lin YJ, Cheng LC, Huang HY. Shock index to predict outcomes in patients with trauma following traffic collisions: a retrospective cohort study. Eur J Trauma Emerg Surg. 2024 Oct;50(5):2191-2198. doi: 10.1007/s00068-024-02545-4. Epub 2024 May 31.
PubMed 38819683Bouzat P, Ageron FX, Brun J, Levrat A, Berthet M, Rancurel E, Thouret JM, Thony F, Arvieux C, Payen JF; TRENAU group. A regional trauma system to optimize the pre-hospital triage of trauma patients. Crit Care. 2015 Mar 18;19(1):111. doi: 10.1186/s13054-015-0835-7.
PubMed 25887150Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974 Mar;14(3):187-96. No abstract available.
PubMed 4814394Rating the severity of tissue damage. I. The abbreviated scale. JAMA. 1971 Jan 11;215(2):277-80. doi: 10.1001/jama.1971.03180150059012. No abstract available.
PubMed 5107365
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Assessment of Referral of a Major Trauma Patient in Val-d'Oise
- ClinicalTrials.gov ID
- NCT06551350
- Acronym / sponsor ID
- SAMU-TRAUMAS / CHRD0924
- Conditions
- Trauma Injury
- Keywords
- Major trauma, Mobile Intensive Care Unit (MCIU)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 461 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 13 Aug 2024 (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.
The aim of this study is to find out whether major trauma patients from the Val d'Oise are referred to the appropriate trauma centre for their care and to assess the quality of triage within the Val d'Oise department.
Detailed description
In France, the number of major trauma is estimated at between 15,000 and 20,000 per year. It is the leading cause of death in patients under the age of 40, and is a significant source of long-term dependency. Mortality from severe trauma varies depending on the region and the circumstances of the accident. Effective initial care and referral to specialist trauma centres are crucial to improving survival. Access to these centres must be guaranteed throughout France. Trauma centres play a central role in the management of serious trauma patients. They are classified by level, from level I to level III.
The triage process aims to direct the patient to the trauma centre with the appropriate level of care. The challenge is to send the "right patient to the right place at the right time". Over-triage and under-triage are two critical concepts in the management of trauma patients. Over-triage (patients considered to be more seriously injured than they really are) leads to excessive consumption of resources and increases waiting times for patients who really need a level I or II trauma centre. Under-triage (patients considered to be less seriously injured than they really are), is characterised by patients being referred to a trauma centre that is insufficiently equipped for their needs, compromises their chances of survival and recovery. In both cases, the loss of chance for the patient is real.
The aim of this study is to find out whether major trauma patients from the Val d'Oise are referred to the appropriate trauma centre for their care, and to assess the quality of triage within the Val d'Oise department.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients regulated by SAMU 95 with suspected major trauma between the 1st January 2023 and the 31th December 2023.
Key inclusion criteria (4 listed)
- Between the 1st January 2023 and the 31th December 2023
- Regulated by SAMU 95 with suspected major trauma
- Sending an MCIU
- At least 1 Vittel criterion*
Key exclusion criteria (10 listed)
- Death on site
- Care by an MICU team outside the 95
- Minor patients and legal protection
- Transport refusals
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 |
|---|---|---|
| Data CollectionCollection of medical data from MICU intervention file and the medical records of patients at the destination hospital | Other | – |
Primary outcome
Triage assessment of a major trauma patient
Time frame: At the end of the study, an average of 9 month
The criterion is the evaluation of the referral of the major trauma patient after post-Medics injury assessment into over, normo and under-triage The over-triage patient is referred to a level I trauma centre with an Injury Severity Score (ISS) <16 The normo-triage patients are either referred to: * a level 1 trauma centre with an ISS >15 * the local scanner and then to an intensive care unit at the scanner site * in the emergency department and then to a surgical unit * emergency with a return home afterwards The under-triage patient is either referred to: * the local scanner and then to a level 1 trauma centre * initially emergency with hospitalisation in an intensive care or continuing care unit afterwards
7 secondary outcomes
Assess if the intervention time is correlated with an under-triage
Time frame: At the end of the study, an average of 9 month
Assess if presumed alcohol intoxication is correlated with a higher rate of under-triage
Time frame: At the end of the study, an average of 9 month
Assess if deliberate toxic poisoning is correlated with a higher rate of under-triage
Time frame: At the end of the study, an average of 9 month
Assess if the TRENAU grade is predictive in pre-hospital of an appropriate referral following an intra-hospital trauma assessment
Time frame: At the end of the study, an average of 9 month
Assess if the positive Shock-Index is predictive of an appropriate pre-hospital referral to a level 1 trauma centre
Time frame: At the end of the study, an average of 9 month
Assess if the positive Shock-Index ( ≥ 0.9 ) is predictive of an intra-hospital blood transfusion
Time frame: At the end of the study, an average of 9 month
Assess if the MGAP is predictive of an appropriate referral following an intra-hospital trauma assessment
Time frame: At the end of the study, an average of 9 month
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 5 Dec 2024.
- Background: PubMed 16436768MacKenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Frey KP, Egleston BL, Salkever DS, Scharfstein DO. A national evaluation of the effect of trauma-center care on mortality. N Engl J Med. 2006 Jan 26;354(4):366-78. doi: 10.1056/NEJMsa052049.
- Background: PubMed 26635210Haagsma JA, Graetz N, Bolliger I, Naghavi M, Higashi H, Mullany EC, Abera SF, Abraham JP, Adofo K, Alsharif U, Ameh EA, Ammar W, Antonio CA, Barrero LH, Bekele T, Bose D, Brazinova A, Catala-Lopez F, Dandona L, Dandona R, Dargan PI, De Leo D, Degenhardt L, Derrett S, Dharmaratne SD, Driscoll TR, Duan L, Petrovich Ermakov S, Farzadfar F, Feigin VL, Franklin RC, Gabbe B, Gosselin RA, Hafezi-Nejad N, Hamadeh RR, Hijar M, Hu G, Jayaraman SP, Jiang G, Khader YS, Khan EA, Krishnaswami S, Kulkarni C, Lecky FE, Leung R, Lunevicius R, Lyons RA, Majdan M, Mason-Jones AJ, Matzopoulos R, Meaney PA, Mekonnen W, Miller TR, Mock CN, Norman RE, Orozco R, Polinder S, Pourmalek F, Rahimi-Movaghar V, Refaat A, Rojas-Rueda D, Roy N, Schwebel DC, Shaheen A, Shahraz S, Skirbekk V, Soreide K, Soshnikov S, Stein DJ, Sykes BL, Tabb KM, Temesgen AM, Tenkorang EY, Theadom AM, Tran BX, Vasankari TJ, Vavilala MS, Vlassov VV, Woldeyohannes SM, Yip P, Yonemoto N, Younis MZ, Yu C, Murray CJ, Vos T. The global burden of injury: incidence, mortality, disability-adjusted life years and time trends from the Global Burden of Disease study 2013. Inj Prev. 2016 Feb;22(1):3-18. doi: 10.1136/injuryprev-2015-041616. Epub 2015 Dec 3.
- Background: PubMed 26628327Hirsch M, Carli P, Nizard R, Riou B, Baroudjian B, Baubet T, Chhor V, Chollet-Xemard C, Dantchev N, Fleury N, Fontaine JP, Yordanov Y, Raphael M, Burtz CP, Lafont A; health professionals of Assistance Publique-Hopitaux de Paris (APHP). The medical response to multisite terrorist attacks in Paris. Lancet. 2015 Dec 19;386(10012):2535-8. doi: 10.1016/S0140-6736(15)01063-6. Epub 2015 Nov 28. No abstract available.
- Background: PubMed 26592159Cotte J, Courjon F, Beaume S, Prunet B, Bordes J, N'Guyen C, Contargyris C, Lacroix G, Montcriol A, Kaiser E, Meaudre E. Vittel criteria for severe trauma triage: Characteristics of over-triage. Anaesth Crit Care Pain Med. 2016 Apr;35(2):87-92. doi: 10.1016/j.accpm.2015.06.013. Epub 2015 Dec 1.
- Background: PubMed 20068467Sartorius D, Le Manach Y, David JS, Rancurel E, Smail N, Thicoipe M, Wiel E, Ricard-Hibon A, Berthier F, Gueugniaud PY, Riou B. Mechanism, glasgow coma scale, age, and arterial pressure (MGAP): a new simple prehospital triage score to predict mortality in trauma patients. Crit Care Med. 2010 Mar;38(3):831-7. doi: 10.1097/CCM.0b013e3181cc4a67.
- Background: PubMed 38819683Liao TK, Ho CH, Lin YJ, Cheng LC, Huang HY. Shock index to predict outcomes in patients with trauma following traffic collisions: a retrospective cohort study. Eur J Trauma Emerg Surg. 2024 Oct;50(5):2191-2198. doi: 10.1007/s00068-024-02545-4. Epub 2024 May 31.
- Background: PubMed 25887150Bouzat P, Ageron FX, Brun J, Levrat A, Berthet M, Rancurel E, Thouret JM, Thony F, Arvieux C, Payen JF; TRENAU group. A regional trauma system to optimize the pre-hospital triage of trauma patients. Crit Care. 2015 Mar 18;19(1):111. doi: 10.1186/s13054-015-0835-7.
- Background: PubMed 4814394Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974 Mar;14(3):187-96. No abstract available.
- Background: PubMed 5107365Rating the severity of tissue damage. I. The abbreviated scale. JAMA. 1971 Jan 11;215(2):277-80. doi: 10.1001/jama.1971.03180150059012. No abstract available.
- Insee. Statistiques sur les accidents En France.Link provided by the sponsor.
- Santé publique France. "Traumatismes non intentionnels." Bulletin épidémiologique hebdomadaire. 2023Link provided by the sponsor.
- Trauma center Association of America. Best Practices in Trauma CareLink provided by the sponsor.
- Santé publique France. "Traumatismes et accidents de la vie courante." Publié le 6 mai 2022Link provided by the sponsor.
- Thèse de Doctorat Université de Rennes 1Link provided by the sponsor.
- Thèse de Doctorat en santé Publique - Epidémiologie. Université Paris-SaclayLink provided by the sponsor.
Related trials for Trauma Injury
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
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.
Fabrice LOUVET principal investigator
Hôpital NOVO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury, run by Hôpital NOVO at 1 site 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 4 inclusion and 10 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 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Maryline DELATTRE (+3333130754131, maryline.delattre@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triage assessment of a major trauma patient (time frame: At the end of the study, an average of 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06551350, which also lists 9 linked publications.
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 5 Dec 2024.