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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 August 2021 |
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Main ID: |
NCT03313505 |
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Date of registration:
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13/10/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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PROtein S100B for Mild Trauma of the HEad in Emergency Patients
PROMETHEE |
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Scientific title:
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PROtein S100B for Mild Trauma of the HEad in Emergency Patients |
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Date of first enrolment:
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May 14, 2018 |
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Target sample size:
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787 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03313505 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Monaco
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Contacts
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Name:
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Karim TAZAROURTE, PU-PH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospices Civils de Lyon |
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Name:
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Yann-Erick CLAESSENS, PU-PH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Princesse Grace |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult Patients
- Victims of mild head trauma at risk of complication :
o Adult patients with head trauma with:
- retrograde amnesia of more than 30 minutes, or
- loss of consciousness or amnesia of the facts associated with:
- Either a risky mechanism (pedestrian overturned by a motor vehicle, ejection of a
vehicle, drop of more than one meter),
- either An age> 65 years,
- Either clotting disorders, including platelet aggregation therapy.
- either Glasgow Score to 15
- Admitted to the emergency department within three hours of the traumatic event.
Exclusion Criteria:
- Refusal to participate at the study
- Patients with obstacle to 7 days follow up
- Pregnant women
- Patients not subject to an health insurance scheme in France or Monaco.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mild Traumatic Brain Injury
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Intervention(s)
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Other: Brain CT scan
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Biological: S100B protein dosage
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Primary Outcome(s)
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Evaluation of the number of brain CT-scan saved in patients who have been tested for S100B protein
[Time Frame: 53 weeks]
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Secondary Outcome(s)
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Intensive treatment comparison of the patients included in the centers that carried out an "intensive implementation" of the use of the S100B protein and those included in the centers that provided the S100B protein
[Time Frame: 53 weeks]
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Quantification and evaluation of deviations to the algorithm
[Time Frame: 53 weeks]
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Comparison of supported patients with S100B protein assay or without S100B protein assay
[Time Frame: 53 weeks]
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Secondary ID(s)
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16-09
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2016-A00901-50
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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