Reduced anticoagulation targets in extracorporeal life support (RATE): study protocol for a randomized controlled...

Area of Science:

• Cardiovascular Medicine
• Critical Care Medicine
• Pharmacology

Background:

• Extracorporeal membrane oxygenation (ECMO) offers life support but carries high mortality due to treatment complications.
• Bleeding complications (55%) and blood transfusions are frequent during ECMO and linked to outcomes, unlike ischemic stroke (1.2%).
• Current heparin dosing guided by activated partial thromboplastin time (aPTT) does not correlate with ischemic stroke risk.

Purpose of the Study:

• To evaluate the non-inferiority of lower anticoagulation targets or low molecular weight heparin (LMWH) compared to standard heparin in ECMO patients.
• To determine if adjusted anticoagulation strategies reduce bleeding complications without increasing thromboembolic events or negatively impacting patient outcomes.

Main Methods:

• A three-arm, non-inferiority randomized controlled trial involving adult ECMO patients.
• Participants randomized to heparin with aPTT targets of 2-2.5x baseline, 1.5-2x baseline, or LMWH guided by weight and renal function.
• Primary outcome: a composite of major bleeding, severe thromboembolic complications (including ischemic stroke), and mortality at 6 months.

Main Results:

• This section is not available in the provided abstract.

Conclusions:

• Hypothesize that reduced anticoagulation targets or LMWH use during ECMO will decrease hemorrhagic complications.
• Anticipate no increase in thromboembolic complications or adverse effects on patient outcomes with modified anticoagulation.
• Study findings could inform changes in ECMO anticoagulation protocols to improve patient outcomes.