Venous thromboembolism in childhood: A prospective two-year registry in The Netherlands

Ommen, C. Heleen van; Heijboer, H.; Büller, Harry R.; Hirasing, R.A.; Heijmans, Hugo S.A.; Peters, Marjolein

doi:10.1067/mpd.2001.118192

Cited by 631 publications

(577 citation statements)

References 27 publications

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“…Estimates of the risks of VTE recurrence after an initial event in children vary8, 9; however, in children, as in adults, recurrence is associated with increased morbidity and mortality,1, 2, 6, 7 hence extended anticoagulant therapy may be warranted until VTE risk factors are resolved 1. Further, although estimates of rates of PTS in children vary considerably,7, 9, 10, 11 it has been found to be associated with increased morbidity and cost 39.…”

Section: Discussionmentioning

confidence: 99%

“…In pediatric patients, VTE has an annual incidence of approximately 0.07‐0.14 events per 10 000 children,2 but the number of cases appears to be rising 3. Raffini et al.…”

Section: Introductionmentioning

confidence: 99%

“…In addition, chronic conditions with interim disease flares such as in inflammatory disorders (eg, systemic lupus erythematosus, bowel disorders, systemic sclerosis, or vasculopathies), infections (eg, infective endocarditis or bone infections), and nephrotic syndrome can be accompanied by intermittent prothrombotic periods. Lastly, acquired risk factors are typically exemplified by the presence of central venous catheters 1, 2, 4, 6, 8, 13, 14, 15…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

“…In pediatric patients, VTE has an annual incidence of approximately 0.07‐0.14 events per 10 000 children,2 but the number of cases appears to be rising 3. Raffini et al.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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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“…[2][3][4] These registries also demonstrated that approximately 90% of venous thromboses in neonates were associated with central venous catheters (CVLs). [2][3][4] The recurrence rate of TE following symptomatic neonatal events ranges from 3.3 to 7%. 5 The international registries are the first step toward increasing recognition of this problem.…”

Section: Incidence Of Neonatal Thromboembolic Diseasementioning

confidence: 99%

“…All three registries observed that thromboses occurred in both term and preterm infants and affected male and female infants equally, other than renal vein thrombosis (RVT) that affected more male neonates. [2][3][4] These registries also demonstrated that approximately 90% of venous thromboses in neonates were associated with central venous catheters (CVLs). [2][3][4] The recurrence rate of TE following symptomatic neonatal events ranges from 3.3 to 7%.…”

mentioning

confidence: 99%

The evaluation and management of postnatal thromboses

Saxonhouse

Burchfield

2009

J Perinatol

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In the pediatric population, neonates have the highest risk for thromboembolism (TE), most likely due to the frequent use of intravascular catheters. This increased risk is attributed to multiple risk factors. Randomized clinical trials dealing with management of postnatal thromboses do not exist, thus, opinions differ regarding optimal diagnostic and therapeutic interventions. This review begins with an actual case study illustrating the complexity and severity of these types of cases, and then evaluates the neonatal hemostatic system with discussion of the common sites of postnatal thrombosis, perinatal and prothrombotic risk factors, and potential treatment options. A proposed step-wise evaluation of neonates with symptomatic postnatal thromboses will be suggested, as well as future research and registry directions. Owing to the complexity of ischemic perinatal stroke, this topic will not be reviewed. Case study A full-term male infant born through spontaneous vaginal delivery was admitted to the neonatal intensive care unit (NICU) shortly after birth due to a history of low APGAR scores and respiratory distress requiring mechanical ventilation. The pregnancy was complicated by gestational diabetes treated with glyburide and chorioamnionitis was evident during labor. The patient was started on ampicillin and gentamicin and appropriate fluid resuscitation was initiated. The patient improved over the next few days and was able to be weaned off of ventilator support. The patient had an umbilical arterial catheter (UAC) placed after birth that was removed on day 3 of life.On day 4 of life the patient's legs appeared pale. Physical examination demonstrated cool lower extremities and markedly decreased pulses in the feet. Over the previous 24 h, urine output declined significantly.Ultrasound (US) examination of the heart, major vessels and abdomen demonstrated a large thrombus in the descending aorta with very minimal flow to the renal and iliac arteries. A literature search did not reveal any level I management guidelines for thrombosis in neonatal patients, and consideration is now given to surgical thrombectomy, anticoagulation therapy or fibrinolytic therapy. Incidence of neonatal thromboembolic diseaseAlthough neonates have the highest risk of thromboembolism (TE) in the pediatric population, the incidence of postnatal TE varies due to the types of thromboses that were reported and how aggressively centers screened for thromboses. 1 Data from the three international registries are displayed in Table 1. All three registries observed that thromboses occurred in both term and preterm infants and affected male and female infants equally, other than renal vein thrombosis (RVT) that affected more male neonates. [2][3][4] These registries also demonstrated that approximately 90% of venous thromboses in neonates were associated with central venous catheters (CVLs). [2][3][4] The recurrence rate of TE following symptomatic neonatal events ranges from 3.3 to 7%. 5 The international registries are the first step toward...

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Systemic treatments for the prevention of venous thrombo-embolic events in pediatric cancer patients with tunnelled central venous catheters

Schoot¹,

Kremer²,

Wetering³

et al. 2011

Cochrane Database of Systematic Reviews

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Venous thromboembolism in childhood: A prospective two-year registry in The Netherlands

Cited by 631 publications

References 27 publications

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

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

The evaluation and management of postnatal thromboses

Systemic treatments for the prevention of venous thrombo-embolic events in pediatric cancer patients with tunnelled central venous catheters

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