Comparison of two pediatric cases requiring the use of bivalirudin during cardiopulmonary bypass
Bryant ME, Regan WL, Fynn-Thompson F, Hoganson D, Nasr VG, Zaleski K, Faella K, Matte GS (2018) · Perfusion · n=2
Study Profile
- Design
- case comparison of two pediatric cardiopulmonary bypass cases (bilateral lung transplant and ventricular assist device implantation) using identical bivalirudin protocol
- Sample size (n)
- 2
- Intervention
- Bivalirudin 1 mg/kg bolus + 50 mg pump prime + 2.5 mg/kg/h infusion titrated to K-ACT >400s during CPB
- Comparator
- Same protocol comparison between BLT and VAD implantation
- Primary endpoint
- K-ACT achievement and dose titration requirements during pediatric CPB
- Primary result
- BLT case maintained K-ACT >720s despite reducing infusion to 0.5 mg/kg/h; VAD case required infusion increase to 5.0 mg/kg/h for low K-ACTs; both cases successful but highlight dose variability
- Follow-up duration
- CPB run duration
- PMID
- 29638202
Key Findings
- 10-fold variability in bivalirudin dose requirements between two pediatric CPB cases
- BLT case over-anticoagulated, VAD case required dose escalation
- Same starting protocol but dramatically different titration needed
- Recommends minimum infusion of 0.5 mg/kg/h
- One-page timeline protocol shared for adoption
Limitations
- Only 2 cases - case comparison not generalizable
- Single-center experience
- Heterogeneous clinical scenarios (transplant vs VAD)
- K-ACT not validated against direct bivalirudin levels
- Not applicable to whole-leech hirudotherapy
Clinical Implications
Bryant 2018 documents extreme inter-patient dose variability in pediatric CPB bivalirudin use, motivating individualized monitoring protocols. For ASH, this Boston Children's case comparison illustrates how the synthetic thrombin inhibitor pharmaceutical pathway requires substantial institutional protocolization, distinct from the K040187 device-leech US clinical practice where dose-equivalent considerations are clinically simpler (number and duration of leech sessions).
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