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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01725-50 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| PROMES UPR 8521 DR2-CNRS | UNKNOWN |
| LPC UMR 6533, Campus Universitaire des Cézeaux | UNKNOWN |
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Objective: To demonstrate the presence of bioresistant intracorporeal carbon-based nanocomposites in subjects exposed to a fulguration, in the immediate aftermath of this fulguration and 24 months (+/- 6 months) after the accident, on blood and urine samples, then in comparison with blood and urine samples from 14 healthy subjects.
Hypothesis: Lightning discharge in the human body reveals the presence of multi-functional nanoparticles which are reassembled under the impact of the electric discharge into nanostructured films, filaments and aggregates; they consist of dispersed graphene-like nanoparticles embedded in an aliphatic cross-reticulated matrix. The high electrical conductivity of the nanoinclusions, their refractory properties and the cross-reticulation of the nanoassemblages explain their biorésistance.
The graphene-like multi-functional nanoparticles are assumed to trace a population of aerosols formed in the atmosphere by plasma discharge which is present in air, water and all natural resources. Their ability to undergo changes from folded nanosheets to confined ultra-fine nanoparticles allow them to be inhaled or absorbed by the human body, or to be ingested with food.
In order to detect nanocomposites in patients who have been impacted by lightning, an analysis protocol will be performed on the remains of blood and urine samples from their initial medical admission. After filtering the blood and urine samples, the remaining nanocomposites are selected for characterization, at micro to nanoscale, using the scanning electron microscope and the transmission electron microscope.
Based on laboratory experiments, a second sampling of blood and urine will be performed 24 months (+/-6 months) after the lightning strike to follow the delayed production of nanocomposites from the remaining activated nanoparticles.
In order to describe the neurological disorders of the patients, initial clinical, biological and radiological data will be collected in the patients' medical records and a new clinical examination will be performed at 24 months (+/- 6 months) after fulguration.
-Search for descriptive data.
testimonials
Data collected:
- During the interrogation of the patient on the day of the fulguration
clinics
Data collected :
organic
Data collected :
imagery
Data collected :
- In the medical file of the patient consulted at the department's administration
H0 will be the time when the accident took place. H0-H12: Collection of clinical, biological and radiological information in the patient's medical record. Recovery at M24 (+/- 6 months) for immediate or prolonged initial neurological disorders.
At M24 (+/- 6 months): medical examination at the patient's home to :
At M24 (+/- 6 months): Description of the evolution of neurological disorders in time, recovery quality and location.
- Presence and description of other organic lesions.
- The objective is to know what other internal organs may have been affected by the lightning strike
- Looking through the medical file for the clinical examination of J0 and those of follow-ups
Description of measures taken to reduce and avoid bias
Measurement bias:
Selection bias:
- None, because all 14 patients were fulgurated.
Memory bias:
- Cross-check the patients' testimonies with the analyses and complementary examinations carried out, requested by the attending physician or another health professional.
Sampling bias:
- Matching the 14 healthy subjects to the age and sex of the 14 fulgurated subjects.
In order to better understand the mechanisms of in vivo formation of these nanocomposites, an attempt will be made to identify them in healthy subjects.
-Qualitative and quantitative aspects of bioremediation nanocomposites possibly identified in the blood of subjects not affected by lightning-strike.
Analysis of the blood of 14 healthy patients for:
Low levels of bioresistant nanocomposites are expected in this group. The aim is to trace the occurrence of nanocomposites formed by plasma discharges in the atmosphere which have passed through the alveolar and digestive barrier into the bloodstream.
The blood of healthy subjects will be collected at the Aurillac CH laboratory by taking an additional 18 ml on sodium heparinate tube during a blood test for routine check-up (INR monitoring for example). Patients will be given an information note and a consent form stating that they accept this additional volume of sample. They will inform their work and their commune of residence.
The samples will be anonymised and packaged for transport to the Aurillac laboratory for analysis under a stereomicroscope microscope in the alcoholic liquid phase. They will then be sent in dry form to the CNRS for analysis by scanning and transmission electron microscope.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| victims | thirteen patients affected by lightning in collective fulguration |
| |
| healthy witnesses | fourteen healthy witnesses who have never been in contact with lightning, matched on age and sex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nano-composite screening | Diagnostic Test | Recovery of the bottoms of the victims' blood and urine tubes at H+4. Blood and urine samples from the victims at two years of age. Single blood and urine samples from the witnesses |
| Measure | Description | Time Frame |
|---|---|---|
| Description of bioresistant nanocomposites | Characterization in blood | Day 0 |
| Description of bioresistant nanocomposites | Characterization in blood | Month 24 |
| Description of bioresistant nanocomposites | Characterization in urine | Hour 12 |
| Description of bioresistant nanocomposites | Characterization in urine | Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| neurological disorders | Research and description of neurological disorders with questioning of date of onset and duration | Day 0 |
| neurological disorders | Research and description of neurological disorders with questioning of date of onset and duration |
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Inclusion criteria :
-Patients exposed: all subjects who were victims of the fulguration accident.
Non-exposed patients:
Exclusion criteria :
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patients affected by lightning in collective fulguration and healthy witnesses who have never been in contact with lightning, matched on age and sex
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Caumon | CH Henri Mondor (Aurillac) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Henri Mondor | Aurillac | France | ||||
| CH de Luneville |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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Recovery of the bottoms of the victims' blood and urine tubes at H+4. Blood and urine samples from the victims at two years of age. Single blood and urine samples from the witnesses
| Month 24 |
| neuropsychological disorders | Research and description of neuropsychological disorders with questioning of date of onset and duration | Day 0 |
| neuropsychological disorders | Research and description of neuropsychological disorders with questioning of date of onset and duration | Month 24 |
| Lunéville |
| France |
| CHRU Bradois | Nancy | France |
| CHRU de Nancy | Nancy | France |
| CH de SAINT-DIE-DES-VOSGES | Saint-Dié | France |