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Trends in parenteral direct thrombin inhibitor use in pediatric patients: analysis of a large administrative database
1From the Department of Pharmacy, Texas Children's Hospital, and the Department of Pediatrics, Section of Pediatric Cardiology, Baylor College of Medicine, Houston (Dr Moffett); and the Department of Pathology & Immunology, Pediatrics, and Medicine, Texas Children's Hospital and Baylor College of Medicine, Houston (Dr Teruya).
Insights
Direct thrombin inhibitors (DTIs) are rarely used in pediatric patients, often those with serious underlying conditions. Bleeding complications were frequent, particularly with certain DTIs, highlighting the need for careful monitoring in this population.
Area of Science:
- Pediatric pharmacology
- Thrombosis management
- Anticoagulation therapy
Background:
- Parenteral direct thrombin inhibitors (DTIs) offer an alternative for pediatric patients with contraindications to heparin, such as heparin-induced thrombocytopenia.
- Limited data exist on the clinical use, monitoring, and complications of DTIs in pediatric populations.
Purpose of the Study:
- To characterize the utilization patterns of parenteral DTIs in pediatric patients.
- To evaluate the monitoring strategies employed during DTI therapy.
- To identify and analyze the incidence of bleeding complications associated with DTI use in children.
Main Methods:
- A retrospective descriptive study design was utilized.
- The Pediatric Health Information System database was queried for pediatric patients receiving parenteral DTIs between 2004 and 2011.
- Data collected included patient demographics, diagnoses, procedures, DTI type, monitoring parameters, bleeding complications, and mortality.
Main Results:
- The study included 208 pediatric patients, with a high prevalence of congenital heart disease (43.8%) and cardiovascular surgery (28.4%).
- Argatroban was the most frequently used DTI (73.1%), with increasing use of bivalirudin over time.
- Bleeding complications occurred in 37.9% of patients, with higher rates observed for lepirudin and argatroban compared to bivalirudin. Mortality was 19.7%.
Conclusions:
- Parenteral DTI use in pediatric patients is infrequent.
- Pediatric patients receiving DTIs typically have significant comorbidities and are associated with high rates of morbidity and mortality.
- The choice of DTI may influence the risk of bleeding complications, necessitating tailored monitoring approaches.
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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