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Thromb J. 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.

Author information

1
1McMaster Children's Hospital, Hamilton, Canada.
2
2Bayer AG, Wuppertal, Germany.
3
3Bayer U.S., LLC, Whippany, USA.
4
Research and Development, Thrombosis and Hematology, Building 402, room 304, Aprather Weg 18a, 42113 Wuppertal, Germany.
5
Competitive Drug Development International Ltd. (CDDI), London, UK.
6
5Hospital Universitario La Paz, Madrid, Spain.
7
Children's Hospital of Eastern Ontario (CHEO), University of Ottawa, Ottawa, Canada.
8
7Division of Neuropaediatrics, Development and Rehabilitation, University Children's Hospital, University of Bern, Bern, Switzerland.
9
8Sheba medical center, Ramat Gan, Israel.
10
9Hôpital Necker- Enfants Malades, Paris, France.
11
10Hospital Vall d'Hebron, Barcelona, Spain.
12
11University Hospital, Città della Salute e della Scienza di Torino, Ospedale Infantile Regina Margherita, Torino, Italy.
13
12The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
14
13Hospital Universitario La Paz, Madrid, Spain.
15
14The Noah's Ark Children's Hospital for Wales, University Hospital of Wales, Cardiff, UK.
16
Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, USA.
17
16Hemostasis and Thrombosis Center (HTC), Children's Hospital Los Angeles, Los Angeles, USA.
18
Department of Haematology, Royal Children's Hospital, Department of Paediatrics, University of Melbourne, Murdoch Children's Research Institute, Melbourne, Australia.

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)

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.

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