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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Carmen Higueras, PhD
- Número de telefone: +34 934 65 12 00
- E-mail: chigueras.germanstrias@gencat.cat
Estude backup de contato
- Nome: Maria Del RIo, PhD
- Número de telefone: +34 934 65 12 00
- E-mail: mariadelriomd@gmail.com
Locais de estudo
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Barcelona
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Badalona, Barcelona, Espanha, 08916
- Recrutamento
- Germans Trias i Pujol Universitary Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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presence or absence of bilateral and symmetrical distribution of indocyanin green drainage
Prazo: 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.
Prazo: 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.
Prazo: baseline
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cervical nodes receiving the migrated ICG anatomical level location
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baseline
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ICGBRAIN
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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