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Study of the Brain's Natural Cleaning System in Potential Organ Donors. (ICGBRAIN)

2026年8月18日 更新者：Germans Trias i Pujol Hospital

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

10

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 西班牙
    • Barcelona
      • Badalona、Barcelona、西班牙、08916
        • 招聘中
        • Germans Trias i Pujol Universitary Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
程序：Indocynanine Green meningeal injection to understand anatomical connection from the meningeal lymphatic system to the cervical lymph nodes
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
presence or absence of bilateral and symmetrical distribution of indocyanin green drainage
大体时间：baseline
indocyanin green drainage pathway and distribution
baseline
Assessment of the Indocyanin Grees pathways in its migration through the lymph channels to the cervical region.
大体时间：baseline
The fluorescence camera will be used to take images and videos to assess whether flow drainage is present or absent
baseline
Cervical ganglion levels to which the ICG migrates.
大体时间：baseline
cervical nodes receiving the migrated ICG anatomical level location
baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Germans Trias i Pujol Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月1日

初级完成 (估计的)

2026年11月30日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年6月18日

首先提交符合 QC 标准的

2026年6月26日

首次发布 (实际的)

2026年7月2日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月18日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ICGBRAIN

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

The porpouse of this clinical study is to know the existence of a migration flow from the meningeal lymphatic system and cervical lymph nodes. It doesn't describe the population or subjects

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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