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Safety of Bivalirudin Use in Critically Ill Children: A Single-Center Experience
Dalia A Bashir1, Javier Leija2, Rayhan N Jhanji3
1Division of Critical Care Medicine, Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine, Houston, TX.
Insights
Bivalirudin is increasingly used for pediatric thrombosis, but bleeding and new clot events are frequent. Close monitoring is essential for critically ill children receiving this anticoagulant.
Area of Science:
- Pediatric critical care medicine
- Pharmacology and therapeutics
- Hematology and thrombosis
Background:
- Bivalirudin is an IV direct thrombin inhibitor used in pediatric patients for mechanical circulatory support, heparin failure, or heparin-induced thrombocytopenia.
- Limited data exist on its use for treating or preventing venous or arterial thromboses in children.
Purpose of the Study:
- To describe the safety of bivalirudin in critically ill children for the treatment or prevention of venous and/or arterial thromboses.
Main Methods:
- Retrospective review of pediatric patients (<18 years) treated with bivalirudin from January 2019 to August 2024 at a quaternary care children's hospital.
- Descriptive analyses focused on bleeding and thrombotic events, time to therapeutic levels, dosing, and association of therapeutic laboratory goals (PTTHz, bivalirudin levels) with adverse events.
Main Results:
- 261 bivalirudin encounters in 229 pediatric patients (median age 0.51 years) were analyzed. The most common indication was venous thrombosis (51%).
- Bleeding events occurred in 33% of encounters (27% of patients), with 23.2% classified as major. New or progressive thrombosis occurred in 17.6% of encounters (16% of patients).
- Therapeutic levels were achieved rapidly (median 0.56 days). 56.5% of new thromboses and 57% of bleeding events occurred despite therapeutic ranges.
Conclusions:
- Bivalirudin rapidly achieves therapeutic levels for pediatric venous and/or arterial thromboses.
- While considered safe, clinically relevant bleeding and thrombotic rates were frequent, even within therapeutic ranges.
- Bivalirudin use in critically ill children necessitates close monitoring due to observed event rates.
Objectives:
Bivalirudin, an IV direct thrombin inhibitor, is increasingly used as an alternative anticoagulant in pediatric patients on mechanical circulatory support, with heparin failure, or for heparin-induced thrombocytopenia. Data on its use for treatment or prevention of venous or arterial thromboses in children are limited. To describe the safety of bivalirudin in critically ill children for the treatment or prevention of venous and/or arterial thromboses.
Design:
Retrospective review of patients under 18 years treated with bivalirudin between January 2019 and August 2024.
Setting:
Quaternary care Children's Hospital.
Patients:
Descriptive analyses were conducted for all patients receiving bivalirudin. Primary outcomes include bleeding and thrombotic events. Secondary outcomes included time to therapeutic levels, dosing, and the association of therapeutic laboratory goals (via Partial Thromboplastin Time Hepzyme [PTTHz] and dilute thrombin time-derived bivalirudin levels) with adverse events.
Intervention:
None.
Measurements And Main Results:
A total of 261 bivalirudin encounters in 229 patients were included in the analysis (median age, 0.51 yr; interquartile range, 0.13-3.92 yr). The most common indication was treatment of venous thrombosis (n = 133, 51%). Eighty-six bleeding events occurred in 261 encounters (33%) involving 61 of 229 patients (27%); 20 of 86 bleeding events were considered major (23.2%). Thrombotic progression or development of new thrombi occurred in 46 of 261 (17.6%) encounters (37/229; 16% patients) with 18 of 261 experiencing both bleeding and thrombotic events. Therapeutic PTTHz/bivalirudin levels were observed in 56.5% (26/46) of new thromboses/thrombotic progression and 57% (49/86) of bleeding events. Median starting dose and dose at first therapeutic level were 0.15 and 0.2 mg/kg/hr, respectively. Median time to achieve therapeutic anticoagulation was 0.56 days.
Conclusions:
Bivalirudin, used in the setting of venous and/or arterial thromboses, rapidly achieves therapeutic levels. While use of bivalirudin is safe, clinically relevant bleeding and thrombotic rates on bivalirudin were frequent despite therapeutic ranges. These data highlight that bivalirudin use warrants close monitoring in critically ill children.
