Clinical presentation and therapeutic management of venous thrombosis in young children: a retrospective analysis

Abstract

BackgroundVenous thromboembolism (VTE) in young children is not well documented.MethodsClinicians from 12 institutions retrospectively evaluated the presentation, therapeutic management, and outcome of VTE in children younger than 2 years seen in 2011–2016. Feasibility of recruiting these children in EINSTEIN-Jr. phase III, a randomized trial evaluating rivaroxaban versus standard anticoagulation for VTE, was assessed.ResultsWe identified 346 children with VTE, of whom 227 (65.6%) had central venous catheter-related thrombosis (CVC-VTE), 119 (34.4%) had non-CVC-VTE, and 156 (45.1%) were younger than 1 month. Of the 309 children who received anticoagulant therapy, 86 (27.8%) had a short duration of therapy (i.e. < 6 weeks for CVC-VTE and < 3 months for non-CVC-VTE) and 17 (5.5%) had recurrent VTE during anticoagulation (n = 8, 2.6%) or shortly after its discontinuation (n = 9, 2.9%). A total of 37 (10.7%) children did not receive anticoagulant therapy and 4 (10.5%) had recurrent VTE.The average number of children aged < 0.5 years and 0.5–2 years who would have been considered for enrolment in EINSTEIN-Jr is approximately 1.0 and 0.9 per year per site, respectively.ConclusionsYoung children with VTE most commonly have CVC-VTE and approximately one-tenth and one-fourth received no or only short durations of anticoagulant therapy, respectively. Recurrent VTE rates without anticoagulation, during anticoagulation or shortly after its discontinuation seem comparable to those observed in adults. Short and flexible treatment durations could potentially increase recruitment in EINSTEIN-Jr. phase III.

Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein‐Jr phase 3 dose‐exposure‐response evaluation

“…The main study treatment period was 3 months, with the exception of children with catheter-related VTE younger than two years, for whom it was 1 month. 16 Randomization occurred in a 2 (rivaroxaban) to 1 (standard anticoagulation) ratio. The protocol was approved by the institutional review board of each participating center and written permission from a parent or legal guardian and, when appropriate, child assent, was obtained.…”

“…The study was conducted at 107 sites in Australia, Europe, Israel, Japan, China, South America, and North America. The main study treatment period was 3 months, with the exception of children with catheter‐related VTE younger than 2 years, for whom it was 1 month 16 . Randomization occurred in a 2 (rivaroxaban) to 1 (standard anticoagulation) ratio.…”

Concordance of Identified Cases of Pediatric HA-VTE with American College of Physicians and Cincinnati Children’s Hospital HA-VTE Prophylaxis Guidelines Over a 10-Year Period

“…Not surprisingly, this was similar to the risk factors in the general population, including adults. 19,21,26,27 Of note, Baystate Children's Hospital also admits young adults up to age 21. In our study, all patients ages range from 18 to 21 would qualify for our Baystate adult prophylaxis guideline with either mechanical prophylaxis or pharmacologic prophylaxis.…”

“…12 The EINSTEIN-Jr study also showed a small portion of young children with VTE received no or only short duration of anticoagulation. 27 This is likely due to concerns that the risk of hemorrhage outweighs the benefit of prophylactically treating all children with a CVC with antithrombotic agents. According to Nowak-Gottl, the major bleeding risk with low molecular weight heparin prophylaxis is 0.3% whereas minor bleeding risk is about 3%.…”

“…Not surprisingly, this was similar to the risk factors in the general population, including adults. 19 , 21 , 26 , 27 …”