Clinical Trial: Interventional pilot study of thrombus assessment using indocyanine green near-infrared fluorescence imaging and histopathological characterization of circuit thrombi in ECMO circuits and oxygenators (Japan)

Tokyo, May 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061404) titled 'Study of ECMO circuit thrombus assessment using ICG near-infrared fluorescence imaging' on May 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - St Marianna University

Condition: Condition - Acute respiratory failure, acute circulatory failure, or cardiac arrest requiring ECMO support Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 27 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070252

Disclaimer: Curated by HT Syndication.