Key result
Bleeding occurred in 37.9% of pediatric patients on parenteral direct thrombin inhibitors, with lower rates for bivalirudin (18.8%) vs lepirudin (62.5%) and argatroban (41.7%) (P<.001).
Why the study?
What are the trends in use, monitoring strategies, and bleeding complications associated with parenteral direct thrombin inhibitors in pediatric patients?
Observational (n=208)
Yes
What are the trends in use, monitoring strategies, and bleeding complications associated with parenteral direct thrombin inhibitors in pediatric patients?
p-value: p=<.001
In pediatric patients, parenteral direct thrombin inhibitor use is infrequent and associated with high morbidity, though bivalirudin appears to have a lower risk of bleeding complications compared to argatroban and lepirudin.
Adds descriptive pediatric DTI data; hypothesis-generating and leaves open need for prospective safety studies.
CONTEXT: Parenteral direct thrombin inhibitors (DTIs) may be used in pediatric patients with contraindications to heparin therapy, such as heparin-induced thrombocytopenia. Few data exist regarding the use of DTIs in pediatric patients. OBJECTIVE: To characterize the use of DTIs in pediatric patients, including monitoring strategies and bleeding complications. DESIGN: A retrospective descriptive study was designed and the Pediatric Health Information System database was queried from 2004 to 2011 for pediatric patients receiving a parenteral DTI. Patient demographic and hospital data, mortality, disease state, and procedure information (from International Classification of Diseases, Ninth Revision codes) were collected from the query. DTI monitoring information was also collected. Patients were divided into 2 time periods (2004-2007, 2008-2011) to evaluate trends. RESULTS: Two hundred eight patients met study criteria (50.9% male, 64.4% white), and children (2-12 years of age) represented 34.6% of the population. Congenital heart disease was present in 43.8% and cardiovascular surgical procedure occurred in 28.4%. Argatroban was most commonly used (73.1%) and bivalirudin use increased (P < .001). Bleeding complications were present in 37.9% of patients and mortality was 19.7%. Bleeding complications were associated with lepirudin (62.5%) and argatroban (41.7%) more often as compared with bivalirudin (18.8%) (P < .001). Activated partial thromboplastin time and prothrombin time were used more often in patients receiving argatroban and lepirudin in comparison with bivalirudin, and thrombin time was used more often in patients receiving lepirudin (P < .001). Activated clotting time use increased over time (5.1% versus 17.5%, P = .02). CONCLUSION: Pediatric use of DTIs is infrequent and occurs in patients with high morbidity and mortality.
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Moffett et al. (2014) conducted an observational in Pediatric patients requiring parenteral direct thrombin inhibitors (n=208). Parenteral direct thrombin inhibitors was evaluated on Bleeding complications (p=<.001). Bleeding occurred in 37.9% of pediatric patients on parenteral direct thrombin inhibitors, with lower rates for bivalirudin (18.8%) vs lepirudin (62.5%) and argatroban (41.7%) (P<.001).