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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Carmen Higueras, PhD
- 電話番号：+34 934 65 12 00
- メール：chigueras.germanstrias@gencat.cat
研究連絡先のバックアップ
- 名前：Maria Del RIo, PhD
- 電話番号：+34 934 65 12 00
- メール：mariadelriomd@gmail.com
研究場所
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Barcelona
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Badalona、Barcelona、スペイン、08916
- 募集
- Germans Trias i Pujol Universitary Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
presence or absence of bilateral and symmetrical distribution of indocyanin green drainage
時間枠：baseline
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indocyanin green drainage pathway and distribution
|
baseline
|
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Assessment of the Indocyanin Grees pathways in its migration through the lymph channels to the cervical region.
時間枠：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
|
baseline
|
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Cervical ganglion levels to which the ICG migrates.
時間枠：baseline
|
cervical nodes receiving the migrated ICG anatomical level location
|
baseline
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ICGBRAIN
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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