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
Характеристика исследования
- Дизайн
- case comparison of two pediatric cardiopulmonary bypass cases (bilateral lung transplant and ventricular assist device implantation) using identical bivalirudin protocol
- Размер выборки (n)
- 2
- Вмешательство
- Bivalirudin 1 mg/kg bolus + 50 mg pump prime + 2.5 mg/kg/h infusion titrated to K-ACT >400s during CPB
- Компаратор
- Same protocol comparison between BLT and VAD implantation
- Первичная конечная точка
- K-ACT achievement and dose titration requirements during pediatric CPB
- Основной результат
- 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
- Длительность наблюдения
- CPB run duration
- PMID
- 29638202
Ключевые выводы
- 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
Ограничения
- 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
Клиническое значение
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).
Связанные исследования
Hirulog in the treatment of unstable angina. Results of the Thrombin Inhibition in Myocardial Ischemia (TIMI) 7 trial
Fuchs J, Cannon CP (1995)
Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial
Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW (2009)
Experience with pharmacologic leeching with bivalirudin for adjunct treatment of venous congestion of head and neck reconstructive flaps
Harun A, Kruer RM, Lee A, Boahene K, Byrne PJ, Richmon JD (2018)
Heparin and Bivalirudin in Percutaneous Coronary Intervention for Acute Coronary Syndromes: A Review Article
Wang G, Qi K, Li X, Zuo S, Zhang R, Zhao Y, Sun S, Zhang J, Liu X (2024)