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Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal
Ali McMichael1, Jamie Weller2, Xilong Li3
1Department of Pediatrics, Phoenix Children's, Department of Child Health, University of Arizona School of Medicine, Phoenix, AZ.
Insights
This pilot study found that testing bivalirudin versus heparin for anticoagulation in children on extracorporeal membrane oxygenation (ECMO) was feasible. However, bivalirudin was associated with higher thrombotic complications, necessitating further research.
Area of Science:
- Pediatric critical care medicine
- Pharmacology and therapeutics
- Cardiovascular research
Background:
- Anticoagulation is crucial for patients on extracorporeal membrane oxygenation (ECMO).
- Unfractionated heparin is the standard, but bivalirudin is an alternative anticoagulant.
- Limited data exist on bivalirudin's use in pediatric ECMO.
Purpose of the Study:
- To assess the feasibility of a randomized controlled trial (RCT) comparing bivalirudin and unfractionated heparin for anticoagulation in pediatric ECMO.
- To evaluate time at goal anticoagulation as a primary endpoint.
Main Methods:
- An open-label pilot randomized controlled trial (RCT) was conducted between 2018 and 2021.
- Pediatric patients (0 days to <18 years) on ECMO were randomized to receive either bivalirudin or unfractionated heparin.
- The primary outcome was time spent at goal anticoagulation.
Main Results:
- Sixteen patients received bivalirudin, and 14 received heparin; no significant difference in time at goal anticoagulation was observed.
- Hemorrhagic complications were similar, but thrombotic complications were higher in the bivalirudin group (37.5% vs. 0%, p=0.02).
- Patients on bivalirudin received fewer packed red blood cell transfusions (p=0.02).
Conclusions:
- Anticoagulation management with bivalirudin versus heparin in pediatric ECMO is feasible.
- Bivalirudin use was associated with increased thrombotic events.
- Larger multicenter studies are needed to confirm the safety and efficacy of bivalirudin in pediatric ECMO.
Objectives:
To test feasibility of a randomized controlled trial (RCT) with an endpoint of time at goal anticoagulation in children on extracorporeal membrane oxygenation (ECMO) randomized to receive bivalirudin vs. unfractionated heparin.
Design:
Open-label pilot RCT (NCT03318393) carried out 2018-2021.
Setting:
Single-center quaternary U.S. pediatric hospital.
Patients:
Children 0 days to younger than 18 years old supported with ECMO in the PICU or cardiovascular ICU.
Interventions:
Randomization to bivalirudin vs. unfractionated heparin while on ECMO.
Measurements And Main Results:
Sixteen patients were randomized to bivalirudin, and 14 patients were randomized to heparin. There was no difference in the primary outcome, time spent at goal anticoagulation, for patients randomized to bivalirudin compared with those randomized to heparin. While hemorrhagic complications were similar between study groups, thrombotic complications were higher with six of 16 patients in the bivalirudin group having one or more circuit changes compared with 0 of 14 patients in heparin group (mean difference, 37.5% [95% CI, 8.7-61.4%]; p = 0.02). Patients in the bivalirudin group received less packed RBC transfusions vs. those receiving heparin (median [interquartile range], 6.3 mL/kg/d [2.5-8.4 mL/kg/d] vs. 12.2 mL/kg/d [5.5-14.5 mL/kg/d]; p = 0.02).
Conclusions:
In this single-center pilot RCT carried out 2018-2021, we found that the test of anticoagulation therapy of bivalirudin vs. heparin during ECMO was feasible. Larger multicenter studies are required to further assess the safety and efficacy of bivalirudin for pediatric ECMO.
