Clinical Trial: Safe Liberation from V-A ECMO with Pump-Controlled Retrograde Trial Off versus Conventional Weaning Strategies (SAFE-ECMOFF Trial): A Phase II Multicenter Randomized Trial (Japan)

Tokyo, July 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062209) titled 'Safe Liberation from V-A ECMO with Pump-Controlled Retrograde Trial Off versus Conventional Weaning Strategies (SAFE-ECMOFF Trial): A Phase II Multicenter Randomized Trial' on July 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Keio University School of Medicine

Condition: Condition - Patients with V-A ECMO Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to determine the optimal weaning trial strategy and its evaluation criteria, which remain unresolved for patients with V-A ECMO. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - In the control group (conventional group), no additional trials are performed as patients have passed the flow weaning trial. After the V-A ECMO flow is returned to 2.0 L/min, V-A ECMO liberation is performed within 2 days. Interventions/Control_2 - In the intervention group (PCRTO group), prior to initiating PCRTO, it is confirmed that either the activated partial thromboplastin time (aPTT) measured within the past 6 hours is within 1.5 to 2.0 times the baseline value, or the activated clotting time (ACT) measured within the past 1 hour is within 180 to 250 seconds, under continuous infusion of unfractionated heparin. If these thresholds are not met, an intravenous bolus of unfractionated heparin is administered with the aim to achieve the target range. During PCRTO, the ECMO pump speed is reduced in stepwise fashion to achieve ECMO flow of -1.0 to -0.5 L/min and the sweep gas flow is set to 0 L/min. This state is maintained for 0.5 to 1.0 hour. If all standardized criteria are fulfilled, it is defined as a "successful PCRTO trial". Following a successful trial, the V-A ECMO flow is returned to 2.0 L/min, the sweep gas is returned to its baseline settings, and liberation from V-A ECMO is performed within 2 days.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Those aged equal to or more than 18 years; (2) those with peripheral ECMO; and (3) those who have reached readiness to wean status. Key exclusion criteria - The exclusion criteria are as follows: (1) planned configuration change to another mechanical circulatory support (MCS) device, such as a left ventricular assist device, upon ECMO weaning; (2) use of hybrid ECMO; (3) ECMO initiation for non-cardiac indications, including acute aortic dissection or aortic aneurysm, hypothermia, primary cerebral disorders, drug intoxication, trauma, suffocation, or drowning; (4) contraindication to unfractionated heparin; (5) known or suspected pregnancy; (6) ECMO discontinuation due to withdrawal of life-sustaining therapy; (7) prior enrolment in this trial; (8) refusal to participate by patients or representatives; and (9) any other condition deemed ineligible by the attending physician. Target Size - 155

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 30 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2033 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071189

Disclaimer: Curated by HT Syndication.