Anti-factor Xa Monitoring and Activated Charcoal for a Pediatric Patient With Rivaroxaban Overdose.

Rivaroxaban, an oral anticoagulant, directly inhibits factor Xa (FXa). A 35-month-old boy was brought to the emergency department 15 minutes after ingesting 200 mg of rivaroxaban (16 mg/kg). Activated charcoal (AC) was administered; the patient was observed with monitoring of plasma anti-FXa levels and discharged the following day after an uneventful hospital observation. We identified two case series and seven case reports of potentially toxic rivaroxaban ingestion in the literature. No serious adverse effects were reported. The present case is the first reported use of anti-FXa monitoring after rivaroxaban ingestion. The magnitude of the effect of AC administration in this patient is unclear.

Comparison of oral antibiotic failure rates in post-Roux-en-Y gastric bypass patients versus controls.

BACKGROUND: Due to the malabsorptive nature of the Roux-en-Y gastric bypass (RYGB), there is a potential for impaired absorption of oral medications. Clinical outcomes of patients who receive oral antibiotics after RYGB have not been adequately described in the literature. OBJECTIVES: The primary objective was composite therapeutic failure. Secondary objectives included comparing failure rates between antibiotic classes and at various time points since RYGB. SETTING: University hospital, United States. METHODS: Patients with a history of RYGB and controls who received an eligible oral antibiotic for urinary tract infection, skin and soft tissue infection, or community acquired pneumonia between April 1, 2008, and September 30, 2015, were included via retrospective chart review. Therapeutic failure rates between groups were compared and adjusted for body mass index and infection type. Failure rates among antibiotic classes and various time points since RYGB (0-1 yr, 1-1.9 yr, and≥2 yr) were also compared. RESULTS: A total of 58 RYGB and 128 controls met inclusion and exclusion criteria. Composite therapeutic failure occurred in the RYGB and control group in 14 (24.1%) and 20 patients (15.6%), respectively (P = .18; odds ratio, 1.8; 95% confidence interval .8-4.4). RYGB patients who received fluoroquinolones or sulfonamides had a significantly increased risk of therapeutic failure. CONCLUSIONS: RYGB was not associated with a statistically significant increased risk of composite therapeutic failure of oral antibiotics in the treatment of urinary tract infection, skin and soft tissue infection, or community acquired pneumonia compared with patients with no history of gastrointestinal resection. Further research is warranted to understand clinical outcomes of RYGB patients who receive oral antibiotics.

Recruitment in Clinical Trials: The Use of Zelen's Prerandomization in Recent Neurovascular Studies.

OBJECTIVE: Randomized allocation of treatment options is not well accepted within the clinical community. Some methods of implementation may be received more favorably than others. Prerandomization may be an acceptable means to facilitate recruitment in some clinical trials. METHODS: We first compare randomization and prerandomization using illustrative neurovascular trials. We review some problems with conventional trials, Zelen's prerandomization as an alternative method, and the ethical issues that have surrounded prerandomization since its inception in a historic trial. Conventional and Zelen's randomization are then compared with other means to provide and verify care in the context of clinical uncertainty. RESULTS: The major problem with conventional randomization is that consent is requested for 2 management options, one of which the patient will not receive. The problem with prerandomization is that treatment is allocated before the patient has consented to trial participation. Prerandomization may trade recruitment difficulties for excessive crossovers. However, other ways to practice under uncertainty and verify patient outcomes, such as case series and registries, are more ethically and scientifically problematic. CONCLUSIONS: Until the ethical functions of randomized allocation of selected treatment options in the care of patients are recognized by the neurovascular community, Zelen's prerandomization may help recruitment into difficult trials and contribute a means to provide best possible care in the presence of uncertainty.