A cross-sectional study evaluating post-thrombotic syndrome in children

Kuhle, Stefan; Koloshuk, Barbara; Marzinotto, Velma; Bauman, Mary E.; Massicotte, Patricia; Andrew, Maureen; Chan, Anthony; Abdolell, Mohamed; Mitchell, Lesley

doi:10.1016/j.thromres.2003.09.008

Cited by 161 publications

(169 citation statements)

References 18 publications

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“…The incidence of clinically significant PTS in children in unknown; reported incidences range from 10% to 60% but comparisons of studies are hampered by a lack of standardization of the evaluation tools and limited follow-up (Manco-Johnson et al, 2000;Monagle et al, 2000;Kuhle et al, 2003). Adaptations of adult PTS scales have been used in paediatric studies to allow assessment in young children and to include specific features of upper limb PTS, e.g.…”

Section: Morbidity and Mortality Associated With Vte In Childrenmentioning

confidence: 99%

Aspects of anticoagulation in children

Payne

2010

Br J Haematol

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SummaryThe number of children receiving anticoagulation is increasing. Thromboembolic events are associated with significant risk of morbidity and mortality although the optimal management of asymptomatic events remains unclear. Specific challenges in paediatrics include the diagnosis of thrombosis, delivery and monitoring of anticoagulation in a wide range of ages from neonates through to adolescents. The development of the haemostatic system as children age results in changing pathophysiology of thrombosis and response to anticoagulation agents. Although registry and observational studies have provided vital information, specific paediatric, prospective anticoagulation studies have been few and limited in design. The result is that much of current practice is extrapolated from adult studies. Traditional anticoagulants have significant limitations. Both heparin and warfarin are in widespread use but many fundamental questions regarding dose, therapeutic range, efficacy and optimum duration have not been fully answered. Alternative agents, such as direct thrombin inhibitors and the selective anti-factor Xa inhibitor fondaparinux, may have advantages for children. Clinical trials in adults and preliminary data in children are promising but caution should be applied until specific paediatric studies have demonstrated safety and efficacy.

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Section: Morbidity and Mortality Associated With Vte In Childrenmentioning

confidence: 99%

Aspects of anticoagulation in children

Payne

2010

Br J Haematol

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“…Use of recognized pediatric‐specific VTE and bleeding‐event classification criteria13 and of a pediatric PTS scoring system10, 37, 38 will also aid such comparisons.…”

Section: Discussionmentioning

confidence: 99%

Phase 3, single‐arm, multicenter study of dabigatran etexilate for secondary prevention of venous thromboembolism in children: Rationale and design

Luciani

Albisetti

Biss

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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BackgroundAnticoagulant therapy for venous thromboembolism (VTE) in children is largely based on treatment recommendations for adults. However, differences in both physiology (ie, renal maturation and drug excretion) and developmental hemostasis must be considered when treating children, as such differences could affect dose appropriateness, safety and efficacy.ObjectivesTo address these concerns, a study was designed to evaluate the safety of dabigatran etexilate in children requiring secondary thrombus prevention in whom an initial VTE was associated with an identified risk factor that persisted after the acute VTE treatment period. We report herein the rationale and design of the study.Patients/MethodsThis phase 3, open‐label, single‐arm, multicenter, multinational, prospective cohort study will be conducted in ≥100 children aged 0 to <18 years at ~100 specialist sites worldwide. Children will be treated with dabigatran etexilate for 12 months, or for a shorter duration if their identified VTE risk factor resolves, as per current American College of Chest Physicians recommendations. A nomogram will be used to determine starting doses for each patient.ResultsThe primary outcomes of the study will be VTE recurrence, bleeding events, overall mortality, and VTE‐related mortality. Secondary outcomes will include occurrence of post‐thrombotic syndrome, the pharmacokinetics of dabigatran, and the need for dose adjustments during treatment. Data on adverse events during the study will also be collected.ConclusionThis study will evaluate the safety of dabigatran etexilate for the secondary prevention of VTE in children, in addition to providing further data to guide pediatric dosing with dabigatran.

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“…Thromboembolism also is associated with long-term complications such as loss of central venous access and post-thrombotic syndrome, which is characterized by pain, swelling, collateralization of vessels, and poor venous return (Kuhle et al, 2003;Monagle et al). The rate of recurrent thrombosis and associated mortality rate are reported to be 8.1% and 2.2%, respectively, in children with acute lymphoblastic leukemia and central venous line-related thrombosis.…”

Section: Thrombophilia Population and Methodsmentioning

confidence: 99%