Impact of inflammation and steroids on anti-coagulation in children supported on a ventricular assist device
Brandewie K, Lorts A, Luchtman-Jones L, Gao Z, Geer B, Villa C, Perry T (2024) · Journal of Artificial Organs · n=10
Характеристика исследования
- Дизайн
- single-center retrospective review of pediatric VAD patients <3 years anticoagulated with bivalirudin (Cincinnati Children's Hospital, October 2020-May 2022)
- Размер выборки (n)
- 10
- Вмешательство
- Bivalirudin anticoagulation with dual aPTT and dilute thrombin time (dTT) monitoring during inflammatory and steroid events
- Компаратор
- Same patients' baseline (non-inflammatory) anticoagulation monitoring patterns
- Первичная конечная точка
- Correlation between aPTT and dTT during 16 infection/inflammation events, 3 chylothorax events, and 6 steroid events
- Основной результат
- Inflammation/infection significantly decreased correlation between dTT and aPTT; dTT increased prior to inflammation/infection while aPTT remained unchanged; dTT more accurately reflected steroid-mediated anticoagulation stabilization
- Длительность наблюдения
- VAD support duration (~19 months observational window)
- PMID
- 38581568
Ключевые выводы
- Inflammation/infection decouple aPTT and dTT correlation
- dTT increases before clinical inflammation diagnosis
- Steroids stabilize anticoagulation, better reflected by dTT than aPTT
- 16 inflammation, 3 chylothorax, 6 steroid events analyzed
- Supports protocol shift from aPTT to dTT monitoring
Ограничения
- Very small cohort (n=10)
- Single-center retrospective design
- Children <3 years - limited generalizability to older children
- No clinical outcome correlation
- Not applicable to whole-leech hirudotherapy
Клиническое значение
Brandewie 2024 refines the safety monitoring framework for bivalirudin in pediatric VAD by demonstrating context-dependent aPTT reliability. For ASH, the study illustrates the granular pharmacovigilance infrastructure that the synthetic thrombin inhibitor pharmaceutical pathway requires, distinct from the much simpler clinical monitoring (visible bleeding, hemoglobin) that suffices for device-leech K040187 US clinical practice.
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)