Target for Anticoagulation in the Management of Venoarterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock : Multicenter randomized controlled trial (TARGET-ECMO trial)

JRCT ID: jRCT1041240069

Registered date:08/08/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Cardiogenic shock associated with acute myocard
ial infarction, cardiomyopathy or myocarditis

• Date of first enrollment: 17/10/2024
• Target sample size: 66
• Study type: Interventional
• Intervention(s): Set management targets for anticoagulation with unfractionated heparin. (aPTT ratio lower group 1.5-1.8, upper group 2.2-2.5)

Outcome(s)

• Primary Outcome: Hierarchical composite outcome of all-cause mortality, bleeding events (BARC criteria type 3 or type 5), thrombosis and total blood transfusion within 7 days after randomization.
• Secondary Outcome: All-cause mortality within 7 days, bleeding events within 7 days, thrombosis within 7 days, total blood transfusion within 7 days, all-cause mortality within 30 days, bleeding events within 30 days, thrombosis within 30 days, duration of VA-ECMO placement, duration of ICU stay.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Cases in which VA-ECMO was introduced to provide circulatory support for cardiogenic shock. Patients with cardiogenic shock with a background of acute myocardial infarction, cardiomyopathy or myocarditis.

Exclude criteria

Cases under 18 years of age.
Cases of cardiac arrest in which there is a strong concern of hypoxic encephalopathy.
(When any of the following (1) to (3) applies.)
(1) Cases which the initial waveform is asystole.
(2) Cases in which it takes more than 20 minutes from cardiac arrest to return of spontaneous circulation (ROSC) or introduction of VA-ECMO
(3) Cases in which the pupillary reflex has disappeared.
Cases with active bleeding and uncontrolled haemostasis or thrombosis at the time of enrolment.
Cases in which withdrawal from VA-ECMO is already expected at the time of inclusion.
Cases of cardiogenic shock due to septic cardiomyopathy.
Cases of cardiomyopathy in the postpartum period.
Perioperative cardiac surgery with open heart surgery.
Cases of acute and chronic pulmonary thromboembolism and pulmonary hypertensive crisis.
Heparin induced thrombocytopenia.
Cases other than those listed above, where the clinician considers it inappropriate to allocate anticoagulant therapy, should be excluded.

Related Information

• Primary Sponsor: Kasugai Daisuke