Study of ECMO circuit thrombus assessment using ICG near-infrared fluorescence imaging

Interventional pilot study of thrombus assessment using indocyanine green near-infrared fluorescence imaging and histopathological characterization of circuit thrombi in ECMO circuits and oxygenators - ICG-ECMO Thrombus Imaging and Histopathology Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061404

Enrollment

Registered

2026-05-01

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory failure, acute circulatory failure, or cardiac arrest requiring ECMO support

Interventions

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 fluoresce

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactTadahito Kato

St Marianna University Department of Pediatrics

tadahito.kato@marianna-u.ac.jp044-977-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026