Age-Dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-Associated Thrombosis in Critically Ill Children: A Post Hoc Analysis of a Bayesian Phase 2b Randomized Clinical Trial.
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Faustino E Vincent S, Raffini Leslie J, Hanson Sheila J, Cholette Jill M, Pinto Matthew G, Li Simon, Kandil Sarah B, Nellis Marianne E, Shabanova Veronika, Silva Cicero T, Tala Joana A, McPartland Tara, Spinella Philip C, for the CRETE Trial Investigators and the Pediatric Critical Care Blood Research Network (BloodNet) of the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI), CRETE Trial Investigators: Clinical Coordinating Center:, and, Data Coordinating Center:, and, Outcomes Adjudication Committee:, and, Data and Safety Monitoring Board:, and, Independent Safety Monitor:, and, Children’s Hospital Wisconsin:, and, Dell Children’s Medical Center:, and, Maria Fareri Children’s Hospital:, and, St. Louis Children’s Hospital:, and, University of Rochester Golisano Children’s Hospital:, and, Weill Cornell Medical Center:, and, and Yale-New Haven Children’s Hospital:, and, for the CRETE Trial Investigators and the Pediatric Critical Care Blood Research Network (BloodNet) of the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI) and CRETE Trial Investigators: Clinical Coordinating Center: and and and Data Coordinating Center: and and and Outcomes Adjudication Committee: and and and Data and Safety Monitoring Board: and and and Independent Safety Monitor: and and and Children’s Hospital Wisconsin: and and and Dell Children’s Medical Center: and and and Maria Fareri Children’s Hospital: and and and St. Louis Children’s Hospital: and and and University of Rochester Golisano Children’s Hospital: and and and Weill Cornell Medical Center: and and and and Yale-New Haven Children’s Hospital: and and
Аннотация
DESIGN: Post hoc analysis of a Bayesian phase 2b randomized clinical trial.
SETTING: Seven PICUs.
PATIENTS: Children less than 18 years old with newly inserted central venous catheter.
INTERVENTIONS: Enoxaparin started less than 24 hours after insertion of central venous catheter and adjusted to anti-Xa level of 0.2-0.5 international units/mL versus usual care.
MEASUREMENTS AND MAIN RESULTS: Of 51 children randomized, 24 were infants less than 1 year old. Risk ratios of central venous catheter-associated deep venous thrombosis with prophylaxis with enoxaparin were 0.98 (95% credible interval, 0.37-2.44) in infants and 0.24 (95% credible interval, 0.04-0.82) in older children greater than or equal to 1 year old. Infants and older children achieved anti-Xa level greater than or equal to 0.2 international units/mL at comparable times. While central venous catheter was in situ, endogenous thrombin potential, a measure of thrombin generation, was 223.21 nM.min (95% CI, 8.78-437.64 nM.min) lower in infants. Factor VIII activity, a driver of thrombin generation, was also lower in infants by 45.1% (95% CI, 15.7-74.4%). Median minimum platelet count while central venous catheter was in situ was higher in infants by 39 × 103/mm3 (interquartile range, 17-61 × 103/mm3). Central venous catheter:vein ratio was not statistically different. Prophylaxis with enoxaparin was less efficacious against central venous catheter-associated deep venous thrombosis at lower factor VIII activity and at higher platelet count.
CONCLUSIONS: The relatively lesser contribution of thrombin generation on central venous catheter-associated thrombus formation in critically ill infants potentially explains the age-dependent heterogeneity in the efficacy of prophylaxis with enoxaparin.