Abstract
Background: Bleeding is a common complication of extracorporeal membrane oxygenation (ECMO) for pediatric cardiac patients. We aimed to identify anticoagulation practices, cardiac diagnoses, and surgical variables associated with bleeding during pediatric cardiac ECMO by combining two established databases, the Collaborative Pediatric Critical Care Research Network (CPCCRN) Bleeding and Thrombosis in ECMO (BATE) and the Extracorporeal Life Support Organization (ELSO) Registry.Methods: All children (<19 years) with a primary cardiac diagnosis managed on ECMO included in BATE from six centers were analyzed. ELSO Registry criteria for bleeding events included pulmonary or intracranial bleeding, or red blood cell transfusion >80 ml/kg on any ECMO day. Bleeding odds were assessed on ECMO Day 1 and from ECMO Day 2 onwards with multivariable logistic regression.Results: There were 187 children with 114 (61%) bleeding events in the study cohort. Biventricular congenital heart disease (94/187, 50%) and cardiac medical diagnoses (75/187, 40%) were most common, and 48 (26%) patients were cannulated directly from cardiopulmonary bypass (CPB). Bleeding events were not associated with achieving pre-specified therapeutic ranges of activated clotting time (ACT) or platelet levels. In multivariable analysis, elevated INR and fibrinogen were associated with bleeding events (OR 1.1, CI 1.0–1.3, p = 0.02; OR 0.77, CI 0.6–0.9, p = 0.004). Bleeding events were also associated with clinical site (OR 4.8, CI 2.0–11.1, p < 0.001) and central cannulation (OR 1.75, CI 1.0–3.1, p = 0.05) but not with cardiac diagnosis, surgical complexity, or cannulation from CPB. Bleeding odds on ECMO day 1 were increased in patients with central cannulation (OR 2.82, 95% CI 1.15–7.08, p = 0.023) and those cannulated directly from CPB (OR 3.32, 95% CI 1.02–11.61, p = 0.047).Conclusions: Bleeding events in children with cardiac diagnoses supported on ECMO were associated with central cannulation strategy and coagulopathy, but were not modulated by achieving pre-specified therapeutic ranges of monitoring assays.
Highlights
Bleeding is a common complication in children supported on extracorporeal membrane oxygenation (ECMO) and has been associated with increased mortality [1, 2]
For the purposes of this analysis, we evaluated risk factors associated with “clinically important” bleeding events defined as pulmonary or intracranial hemorrhage, or massive transfusion (>80 ml/kg of total blood products) on any study day [13]
The majority of patients were post-operative cardiac surgical (112, 60%), most commonly STAT Category >3, and 48 (26%) patients were placed on ECMO directly from cardio-pulmonary bypass (CPB)
Summary
Bleeding is a common complication in children supported on extracorporeal membrane oxygenation (ECMO) and has been associated with increased mortality [1, 2]. Our primary objective was to investigate the relationship between the clinical team’s anticoagulation goals for children on ECMO with bleeding outcomes in the higher risk cardiac population included in the BATE dataset. For this analysis, we chose to leverage the granular anticoagulation monitoring data in the BATE dataset with the robust diagnostic and procedural data reported to the Extracorporeal Life Support Organization (ELSO) Registry. We aimed to identify anticoagulation practices, cardiac diagnoses, and surgical variables associated with bleeding during pediatric cardiac ECMO by combining two established databases, the Collaborative Pediatric Critical Care Research Network (CPCCRN) Bleeding and Thrombosis in ECMO (BATE) and the Extracorporeal Life Support Organization (ELSO) Registry
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