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 Potential Organ Donor
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Carmen Higueras, PhD
- Telefoonnummer: +34 934 65 12 00
- E-mail: chigueras.germanstrias@gencat.cat
Studie Contact Back-up
- Naam: Maria Del RIo, PhD
- Telefoonnummer: +34 934 65 12 00
- E-mail: mariadelriomd@gmail.com
Studie Locaties
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Barcelona
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Badalona, Barcelona, Spanje, 08916
- Werving
- Germans Trias i Pujol Universitary Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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presence or absence of bilateral and symmetrical distribution of indocyanin green drainage
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: baseline
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cervical nodes receiving the migrated ICG anatomical level location
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baseline
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ICGBRAIN
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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