Study of the Brain's Natural Cleaning System in Potential Organ Donors. (ICGBRAIN)
Study of Drainage From the Cerebral Lymphatic System to Deep Cervical Nodes by the Migration of Indocyanine Green in Recent Cadaver
Alzheimer's disease is a condition that affects the brain and is associated with the build-up of waste substances that can damage brain cells. Scientists have recently discovered a natural drainage and cleaning system around the brain, called the meningeal lymphatic system, which may help remove these waste products.
Researchers believe that this brain drainage system is connected to lymph nodes located in the neck. However, this connection has not yet been clearly demonstrated in humans because it is difficult to study.
The purpose of this study is to investigate how fluid drains from the brain to the lymph nodes in the neck. To do this, researchers will use a fluorescent dye called indocyanine green, which can be seen with a special camera. The study will be carried out in potential organ donors who have been authorized for organ donation.
The researchers will record images and videos to observe how the dye moves, how long it takes to reach the lymph nodes, whether the drainage is similar on both sides of the body, and which lymph nodes are involved.
A better understanding of these drainage pathways may help researchers develop and improve future treatments for Alzheimer's disease and other neurological disorders.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Design Prospective interventionist study: in which the flow of lymph fluid from the intracranial region to the deep cervical ganglia will be studied in the potential organ donor (PDO).
Study population Potential organ donor patients (PDO), both donors in Brain Death and Donors in Controlled Asystole, candidates to perform extraction thereof and authorized by the Transplant Coordination of the University Germans Trias i Pujol Hospital.
total number of subjects There will be 20 flow measurements, so if it is bilateral, there would be 10 potential donors.
Variables Images and videos will be obtained using the fluorescence camera. To be evaluated: time, direction, ganglion levels, symmetry. Data source Memory storage of the PDE (Hamamatsu, Photonics) fluorescence device. They will be collected in a database.
Medical history of the donor. Medicinal product or medical device under evaluation (where applicable) Not applicable Data analysis The images and videos collected will be evaluated, analyzing the variables in the different corpses.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Carmen Higueras, PhD
- Telefonnummer: +34 934 65 12 00
- E-mail: chigueras.germanstrias@gencat.cat
Undersøgelse Kontakt Backup
- Navn: Maria Del RIo, PhD
- Telefonnummer: +34 934 65 12 00
- E-mail: mariadelriomd@gmail.com
Studiesteder
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Barcelona
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Badalona, Barcelona, Spanien, 08916
- Rekruttering
- Germans Trias i Pujol Universitary Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Potential organ donor patients, both in Brain Death and in Controlled Asystole, candidates to perform organ harvesting authorized by the Transplant and Tissue Coordination of the Universitary Germans Trias i Pujols Hospital, according to the usual channels and whose family members have previously signed the authorization of the donation and the specific informed consent of the study. Will be included in the study always after death is certified by neurological or cardiocirculatory criteria
Exclusion Criteria:
- Absence of informed consent signed by family members.
- Individuals with a history of having intracranial lymphatic drainage affected.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Interventional single arm
During the donor's usual organ removal, a bicoronal incision and craniectomy will be performed to inject a small amount of indocyanin green into the meningeal space and evaluate migration with a fluorescence chamber.
A small cervical lateral incision is added for flow monitoring and ends with the aesthetic closure of this.
It will be completed with the aesthetic closure of the incisions, which can also be easily hidden.
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Bicoronal incision and craniectomy will be performed to inject a small amount of indocyanin green into the meningeal space and evaluate migration with a fluorescence chamber.
A small cervical lateral incision is added for flow monitoring and ends with the aesthetic closure of this.
It will be completed with the aesthetic closure of the incisions, which can also be easily hidden.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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presence or absence of bilateral and symmetrical distribution of indocyanin green drainage
Tidsramme: baseline
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indocyanin green drainage pathway and distribution
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baseline
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Assessment of the Indocyanin Grees pathways in its migration through the lymph channels to the cervical region.
Tidsramme: baseline
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The fluorescence camera will be used to take images and videos to assess whether flow drainage is present or absent
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baseline
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Cervical ganglion levels to which the ICG migrates.
Tidsramme: baseline
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cervical nodes receiving the migrated ICG anatomical level location
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baseline
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ICGBRAIN
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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