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. 2018 Nov 1:16:29.
doi: 10.1186/s12959-018-0182-4. eCollection 2018.

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

Anthony Chan  1 , Anthonie W A Lensing  2   3   4 , Dagmar Kubitza  2   3 , Grahaem Brown  5 , Dolores Elorza  6 , Marta Ybarra  6 , Jacqueline Halton  7 , Sebastian Grunt  8 , Gili Kenet  9 , Damien Bonnet  10 , Amparo Santamaria  11 , Paola Saracco  12 , Tina Biss  13 , Francesco Climent  14 , Philip Connor  15 , Joseph Palumbo  16 , Kirstin Thelen  2   3 , William T Smith  2   3 , Amy Mason  2   3 , Ivet Adalbo  2   3 , Scott D Berkowitz  2   3 , Eva Hurst  5 , Jeroen van Kesteren  5 , Guy Young  17 , Paul Monagle  18
Affiliations

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

Anthony Chan et al. Thromb J. .

Abstract

Background: Venous thromboembolism (VTE) in young children is not well documented.

Methods: Clinicians 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.

Results: We 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.

Conclusions: Young 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.

Keywords: Anticoagulation; Direct oral anticoagulant (DOAC/NOAC); Pediatric trial; Registry; Rivaroxaban; Venous thromboembolism (VTE).

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Conflict of interest statement

The protocol was approved by the Institutional Review Board or Ethics Committee of each participating center, if required, and de-identified data was retrieved.See above.A.C. has received consulting fees from Bayer, Daiichi Sankyo and Pfizer/BMS. A.W.A.L., D.K., K.T., W.T.S., A.M., I.A., and S.D.B. are employees of Bayer AG. G.B., E.H., and J.K. are employees of. CDDI. D.E., M.Y., J.H., S.G., G.K., D.B., A.S., P.S. T.B.,F.C., P.C., J.P., G.Y. and P.M. declare they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Age of children younger than 2 years diagnosed in 2011–2016 (N = 346)
Fig. 2
Fig. 2
Percentage of the whole population not meeting individual eligibility criteria of the draft EINSTEIN-Jr. protocol. The bars sum to more than 100% because many children would have been excluded by multiple criteria
Fig. 3
Fig. 3
Funnel showing cumulative loss of children aged < 0.5 year due to failure to meet the proposed eligibility criteria. Missing data does not exclude the individual
Fig. 4
Fig. 4
Funnel showing cumulative loss of children aged 0.5–2 years due to failure to meet the proposed eligibility criteria. Missing data does not exclude the individual
See this image and copyright information in PMC

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