Extracorporeal Membrane Oxygenation (ECMO) provides support for critically ill patients with heart and/or lung failure unresponsive to other therapies. The complexities of this invasive technique require coordinated, multidisciplinary patient care among critical care medicine, surgical specialties, cardiology, hematology, transfusion medicine, pharmacy, specialized bedside nursing, and perfusion or ECMO-specialized respiratory therapists. ECMO use in children has increased considerably over the past 20 years, expanding to broader indications and increasingly complex patients. In 2018, almost 3,500 critically ill infants and children were supported with ECMO, with mortality rates as high as 40-50%. Infants and children on ECMO require therapeutic anticoagulation to maintain patency of the ECMO circuit. There are few high-quality data to guide anticoagulation management resulting in high practice variation. Bleeding and clotting remain among the most common, often fatal, ECMO-associated complications. There is a critical need to develop and evaluate optimum anticoagulation management strategies enhanced by expertise from all invested clinician subspecialties and craft groups. Unfortunately, there are rare opportunities for experts from these professional groups to collaborate outside of clinical bedside care. Further, clinical trial design is complicated by the need for multicenter collaboration, lack of standardization, and lack of common definitions of data elements for study. To meet these challenges, we assembled a multidisciplinary team of experts and key stakeholders to convene a series of meetings with the following specific aims:
AIM 1 : Develop evidence-informed consensus statements for management of anticoagulation for infants and children supported with ECMO, using a systematic literature review and modified Delphi process.
AIM 2 : Develop a core set of research priorities and common data elements for pediatric ECMO anticoagulation studies.
AIM 3 : Disseminate and implement anticoagulation management consensus statements, research priorities, and core data elements. Our Key Deliverables from the PEACE Consensus Conferences will be publication of the systematic reviews including consensus-based best practice recommendations to optimize care of infants and children managed on ECMO, identification of key knowledge gaps and research priorities, and definition of consensus-based common data elements for pediatric ECMO anticoagulation to facilitate multicenter studies and enhance future data synthesis to improve outcomes for critically ill pediatric ECMO patients. Our collaborative, multidisciplinary PEACE group and associated research networks stand well poised to design and conduct these future studies.
The proposed consensus conference series is relevant to NIH's mission to foster innovative research strategies and their applications as a basis for ultimately protecting and improving health. Pediatric extracorporeal membrane oxygenation (ECMO) patients face exceptionally high rates of morbidity and mortality often in the setting of bleeding and/or clotting complications. This R13 proposal seeks to develop consensus of anticoagulation management and research priorities from multispecialty collaboration to inform efficient design and conduct of novel multicenter trials of anticoagulation therapies to improve delivery of care, patient safety, and outcomes in critically ill neonates, infants and children.