American Society of Hirudotherapy

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

RCT evidence detailTrial reference
GRADE Very LowInsufficient evidenceCondition: Venous Congestion in Surgical Flaps →
Sample size of this trial compared with other Venous Congestion in Surgical Flaps trialsHuang D 20221232Valdes CA 2023313Hamzah M 2023225Iaprintsev V 202575Trigonis R 202142McMichael A 202430Engel ER 202422Sonmez E 201120Brandewie K 202410Chaudhry-Waterman N 20253
This trial (highlighted) by sample size alongside other indexed Venous Congestion in Surgical Flaps trials. Larger trials generally carry more statistical weight.

Study Profile

Design
single-center retrospective review of pediatric VAD patients <3 years anticoagulated with bivalirudin (Cincinnati Children's Hospital, October 2020-May 2022)
Sample size (n)
10
Intervention
Bivalirudin anticoagulation with dual aPTT and dilute thrombin time (dTT) monitoring during inflammatory and steroid events
Comparator
Same patients' baseline (non-inflammatory) anticoagulation monitoring patterns
Primary endpoint
Correlation between aPTT and dTT during 16 infection/inflammation events, 3 chylothorax events, and 6 steroid events
Primary result
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
Follow-up duration
VAD support duration (~19 months observational window)
PMID
38581568

Key Findings

  • 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

Limitations

  • 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

Clinical Implications

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.

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Trigonis R, Smith N, Porter S, Anderson E, Jennings M, Kapoor R, Hage C, Moiz S, Garcia J, Rahman O (2021)

Bivalirudin versus heparin anticoagulation in patients receiving extracorporeal membrane oxygenation

Huang D, Guan Q, Qin J, Shan R, Wu J, Zhang C (2022)

Heparin-based versus bivalirudin-based anticoagulation in pediatric extracorporeal membrane oxygenation: A systematic review

Valdes CA, Sharaf OM, Bleiweis MS, Jacobs JP, Mumtaz M, Sharaf RM, Jeng EI, Peek GJ (2023)

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