A randomized study comparing low-dose and standard-dose anticoagulation in patients receiving venoarterial ECMO

GUiding optimal Anticoagulation to ReDuce adverse clinical events in Venoatrial ECMO(GUARD-ECMO): A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011898

Enrollment

240

Registered

2026-04-23

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

None listed

Interventions

Drug : All patients will start intravenous infusion of heparin, an anticoagulant, immediately after ECMO initiation. - Intervention arm (Low-dose anticoagulation arm): low-dose anticoagulation strate

or target ACT(activated clotting time) : 140–180 seconds) - Control arm (Standard anticoagulation arm): standard-dose anticoagulation strategy (target aPTT: >1.5 to =2.5 times the normal value

or target ACT: 180–220 seconds) - Monitoring and dose adjustment: aPTT/ACT will be monitored every 4–6 hours during the first 24 hours, and then every 12–24 hours after stabilization, with heparin dos

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adults aged 19 years or older - Patients within 24 hours after initiation of VA-ECMO - Patients who provided written informed consent themselves or through a legally authorized representative

Exclusion criteria

Exclusion criteria: - Active bleeding - Heparin hypersensitivity - Expected ECMO duration of less than 48 hours - Pregnant women - Patients with pulmonary embolism or deep vein thrombosis

Design outcomes

Primary

Measure	Time frame
Composite outcome of bleeding events (International Society on Thrombosis and Haemostasis (ISTH) criteria major bleeding plus clinically relevant minor bleeding) and thrombotic events (at least one of the following: systemic embolic event [SEE], ischemic stroke, or ECMO circuit exchange [performed when ECMO PaO2 is <250 mmHg despite FiO2 100%]	—

Secondary

Measure	Time frame
Bleeding event (“ISTH(International Society on Thrombosis and Haemostasis) criteria major bleeding”, “ISTH criteria major bleeding + Clinically Relevant Minor Bleeding”, “ISTH criteria major bleeding + Clinically Relevant Minor Bleeding + Minor Bleeding”);Thrombosis event (systemic embolic event [SEE], ischemic stroke, or ECMO circuit exchange [performed when ECMO PaO2 is <250 mmHg despite FiO2 100%]);Incidence of individual events comprising the primary composite outcome;Transfusion requirements;Duration of VA-ECMO and number of circuit change;Hemolysis;4Ts score for pretest probability of heparin-induced thrombocytopenia;In-ICU and in-hospital mortality;All-cause mortality at 1 month and 6 months after VA-ECMO initiation;Renal replacement therapy	—

Measure

Time frame

Bleeding event (“ISTH(International Society on Thrombosis and Haemostasis) criteria major bleeding”, “ISTH criteria major bleeding + Clinically Relevant Minor Bleeding”, “ISTH criteria major bleeding + Clinically Relevant Minor Bleeding + Minor Bleeding”);Thrombosis event (systemic embolic event [SEE], ischemic stroke, or ECMO circuit exchange [performed when ECMO PaO2 is <250 mmHg despite FiO2 100%]);Incidence of individual events comprising the primary composite outcome;Transfusion requirements;Duration of VA-ECMO and number of circuit change;Hemolysis;4Ts score for pretest probability of heparin-induced thrombocytopenia;In-ICU and in-hospital mortality;All-cause mortality at 1 month and 6 months after VA-ECMO initiation;Renal replacement therapy

—

Countries

Korea, Republic of

Contacts

Public ContactMinju Han

Seoul National University Hospital

hanminju.im.hi@gmail.com+82-2-2072-1773

Outcome results