Antithrombin supplementation during extracorporeal membrane oxygenation: study protocol for a pilot randomized...

Area of Science:

• Critical Care Medicine
• Hematology
• Cardiopulmonary Support

Background:

• Acquired antithrombin (AT) deficiency is common during extracorporeal membrane oxygenation (ECMO).
• Optimal AT levels for anticoagulation during ECMO are not well-defined.
• Lack of formal recommendations for AT supplementation exists.

Purpose of the Study:

• To evaluate the feasibility and safety of prolonged AT supplementation in veno-venous ECMO patients.
• To assess the impact of AT supplementation on heparin requirements and anticoagulation adequacy.
• To lay the groundwork for a larger trial on AT supplementation's effects.

Main Methods:

• Prospective, randomized, single-blinded, multicenter, controlled two-arm trial (GATRA).
• Patients randomized to AT supplementation (80-120% functional AT) or control group.
• Unfractionated heparin used for anticoagulation; primary endpoint is heparin dose.

Main Results:

• Pilot trial data will assess feasibility and safety.
• Heparin dose and anticoagulation adequacy are key secondary endpoints.
• Hemorrhagic and thrombotic complication rates will be monitored.

Conclusions:

• The GATRA trial will test AT supplementation's efficacy in reducing heparin dose and improving anticoagulation during ECMO.
• Positive findings may support a larger trial investigating AT's impact on clinical outcomes.
• This study addresses a critical gap in ECMO management protocols.