UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061404 |
|---|---|
| Receipt number | R000070252 |
| Scientific Title | Interventional pilot study of thrombus assessment using indocyanine green near-infrared fluorescence imaging and histopathological characterization of circuit thrombi in ECMO circuits and oxygenators |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/28 15:33:59 |
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Basic information
Public title
Study of ECMO circuit thrombus assessment using ICG near-infrared fluorescence imaging
Acronym
ICG-ECMO Thrombus Study
Scientific Title
Interventional pilot study of thrombus assessment using indocyanine green near-infrared fluorescence imaging and histopathological characterization of circuit thrombi in ECMO circuits and oxygenators
Scientific Title:Acronym
ICG-ECMO Thrombus Imaging and Histopathology Study
Region
| Japan |
Condition
Condition
Acute respiratory failure, acute circulatory failure, or cardiac arrest requiring ECMO support
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the feasibility and safety of circuit thrombus assessment using indocyanine green (ICG) near-infrared fluorescence imaging in ECMO circuits, to clarify differences from conventional visual assessment, and to characterize the histopathological features of thrombi formed within ECMO circuits.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The feasibility and safety of ECMO circuit thrombus assessment using ICG near-infrared fluorescence imaging will be evaluated based on the time required for the procedure and the presence or absence of complications and adverse events. Differences from conventional visual assessment will be evaluated based on the number and location of circuit thrombi detected by each assessment method and the percentage of the two-dimensional thrombus area relative to the membrane surface area of the oxygenator.
Key secondary outcomes
Thrombi collected from the oxygenator after weaning from ECMO will be evaluated by electron microscopy and histopathological examination. Associations between the histopathological characteristics of thrombi and the etiology leading to ECMO initiation, duration of ECMO support, systemic corticosteroid use, and blood test findings will also be evaluated.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Indocyanine green (ICG) 0.25 mg diluted 100-fold with normal saline will be administered intravenously. After administration, thrombi in the ECMO circuit will be observed using near-infrared fluorescence imaging.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients admitted to an intensive care unit and receiving ECMO support. Patients of all ages, including neonates, children, and adults, are eligible regardless of the indication for ECMO support or the underlying disease.
2. Patients who are expected to continue ECMO support for at least 12 hours after enrollment in the study.
3.If circuit thrombus assessment is repeated in the same patient, the repeat assessment must be performed at least 24 hours after the initial assessment, with up to two assessments per patient.
Key exclusion criteria
1. Patients diagnosed as brain-dead
2. Patients with a history of iodine hypersensitivity
3. Patients for whom informed consent cannot be obtained
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tadahito |
| Middle name | |
| Last name | Kato |
Organization
St Marianna University
Division name
Department of Pediatrics
Zip code
216-8511
Address
2-16-1 Sugao Kawasaki City, Kanagawa
TEL
044-977-8111
tadahito.kato@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadahito |
| Middle name | |
| Last name | Kato |
Organization
St Marianna University
Division name
Department of Pediatrics
Zip code
216-8511
Address
2-16-1 Sugao Kawasaki City, Kanagawa
TEL
044-977-8111
Homepage URL
tadahito.kato@marianna-u.ac.jp
Sponsor or person
Institute
St Marianna University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee, Clinical Research Section at St. Marianna University
Address
2-16-1 Sugao Kawasaki City, Kanagawa
Tel
044-977-8111
k-sienbu.mail@marianna-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070252
