Enoxaparin Thromboprophylaxis in Children Hospitalized for COVID-19: A Phase 2 Trial

Sochet, Anthony A.; Morrison, John M.; Jaffray, Julie; Godiwala, Nihal; Wilson, Hope P; Thornburg, Courtney D.; Bhat, Rukhmi; Zia, Ayesha; Lawrence, Courtney; Kudchadkar, Sapna R.; Hamblin, Frances; Russell, Christopher J.; Streiff, Michael B.; Spyropoulos, Alex C.; Amankwah, Ernest K.; Goldenberg, Neil A.

doi:10.1542/peds.2022-056726

Cited by 24 publications

(26 citation statements)

References 52 publications

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“…They discussed thromboprophylaxis for those with symptomatic COVID‐19–related illnesses as low‐dose low‐molecular‐weight heparin twice‐daily dosing targeting an anti‐Xa activity level of 0.2 to <0.5 units/ml, with consideration given to additional risk factors for thrombosis 33 . More recently, a Phase 2 trial was published that demonstrated the safety of 0.5 mg/kg/dose twice‐daily dosing with a maximum dose of 60 mg to target an anti‐Xa activity level of 0.2–0.49 IU/ml 34 . These recommendations were published after our participants responded and would likely have increased the number of individuals who would have changed their practice.…”

Section: Discussionmentioning

confidence: 99%

Current practices in pediatric hospital‐acquired thromboembolism: Survey of the Children's Hospital Acquired Thrombosis (CHAT) Consortium

Abrams

Jaffray

Stillings

et al. 2022

Research and Practice in Thrombosis and Haemostasis

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Background: A rise in hospital-acquired venous thromboembolism (HA-VTE) in children has led to increased awareness regarding VTE prophylaxis and risk assessment.Despite this, no consensus exists regarding these practices in pediatrics. Objective:To describe common practices in VTE prophylaxis, VTE risk assessment models, and anticoagulation dosing strategies in pediatric hospitals that are members of the Children's Hospital Acquired Thrombosis (CHAT) Consortium.Methods: An electronic survey of 44 questions evaluating practices surrounding pediatric HA-VTE risk assessment and prevention was distributed between August 9, 2021, and August 30, 2021, to the primary investigators from the 32 institutions within the CHAT Consortium. Results:The survey response rate was 100% (n = 32). In total, 85% (n = 27) of the institutions assess HA-VTE, but only 63% (n = 20) have formal hospital guidelines.Within the institutions with formal guidelines, 100% (n = 20) include acute systemic inflammation or infection and presence of a central venous catheter (CVC) as risk factors for VTE. Pharmacologic prophylaxis is prescribed at 87% (28) of institutions, with enoxaparin being the most frequent (96%, n = 27). Variability in responses persisted regarding risk factors, risk assessment, thromboprophylaxis, dosing of prophylactic anticoagulation or anticoagulant drug monitoring. A majority of providers were comfortable providing thromboprophylaxis across all age groups. In addition, the global coronavirus disease 2019 increased the providers' use of prophylactic anticoagulation 78% (n = 25). Conclusion:Practices among institutions are variable in regard to use of HA-VTE prophylaxis, risk assessment, or guideline implementation, highlighting the need for

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Section: Discussionmentioning

confidence: 99%

Current practices in pediatric hospital‐acquired thromboembolism: Survey of the Children's Hospital Acquired Thrombosis (CHAT) Consortium

Abrams

Jaffray

Stillings

et al. 2022

Research and Practice in Thrombosis and Haemostasis

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“…For children who were clinically unstable or with severe renal impairment the same panel suggested the use of intravenous UFH given by continuous infusion 35 . More recently, the results of an open‐label, multicenter phase 2 trial among 40 children <18 years of age hospitalized for primary COVID‐19 with or without PMIS found twice‐daily enoxaparin thromboprophylaxis (0.5 mg/kg/dose; max of 60 mg/dose) to be safe in achieving target anti‐Xa levels without observed clinically relevant bleeding or related serious adverse events 36 . As such, twice daily weight‐based LMWH at half the treatment dose should be considered for primary thromboprophylaxis in children hospitalized for COVID‐19 with or without PMIS.…”

Section: Hospitalization Periodmentioning

confidence: 99%

Good practice statements for antithrombotic therapy in the management of COVID‐19: Guidance from the SSC of the ISTH

Spyropoulos

Connors

Douketis

et al. 2022

Journal of Thrombosis and Haemostasis

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Despite the emergence of high quality randomized trial data with the use of antithrombotic agents to reduce the risk of thromboembolism, end‐organ failure, and possibly mortality in patients with coronavirus disease 2019 (COVID‐19), questions still remain as to optimal patient selection for these strategies, the use of antithrombotics in outpatient settings and in‐hospital settings (including critical care units), thromboprophylaxis in special patient populations, and the management of acute thrombosis in hospitalized COVID‐19 patients. In October 2021, the International Society on Thrombosis and Haemostasis (ISTH) formed a multidisciplinary and international panel of content experts, two patient representatives, and a methodologist to develop recommendations on treatment with anticoagulants and antiplatelet agents for COVID‐19 patients. The ISTH Guideline panel discussed additional topics to be well suited to a non‐Grading of Recommendations Assessment, Development, and Evaluation (GRADE) for Good Practice Statements (GPS) to support good clinical care in the antithrombotic management of COVID‐19 patients in various clinical settings. The GPS panel agreed on 17 GPS: 3 in the outpatient (pre‐hospital) setting, 12 in the hospital setting both in non‐critical care (ward) as well as intensive care unit settings, and 2 in the immediate post‐hospital discharge setting based on limited evidence or expert opinion that supports net clinical benefit in enacting the statements provided. The antithrombotic therapies discussed in these GPS should be available in low‐ and middle‐income countries.

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“…For patients older than 18 years of age cared for in pediatric centers, it is reasonable to follow adult guidelines, which are based on high-quality, randomized controlled trial data [27 && ,28 && ]. The COVID-19 Anticoagulation in Children -Thromboprophylaxis (COVAC-TP) trial is the only pediatric study evaluating the safety of thromboprophylaxis in children [50]. This study evaluated the safety of low dose LMWH targeting an anti-Xa level of 0.2-0.49 IU/mL in 38 children.…”

Section: Thrombotic Events In Children With Coronavirus Disease 2019 ...mentioning

confidence: 99%

“…The COVID-19 Anticoagulation in Children – Thromboprophylaxis (COVAC-TP) trial is the only pediatric study evaluating the safety of thromboprophylaxis in children [ 50 ]. This study evaluated the safety of low dose LMWH targeting an anti-Xa level of 0.2–0.49 IU/mL in 38 children.…”

Section: Thromboprophylaxis In Children With Coronavirus Disease 2019...mentioning

confidence: 99%

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Thrombotic events in critically ill children with coronavirus disease 2019 or multisystem inflammatory syndrome in children

Dain

Raffini

Whitworth

2022

Current Opinion in Pediatrics

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Purpose of review To provide an update regarding what is known about thrombotic events and thromboprophylaxis in critically ill children with SARS-CoV-2 infection. Recent findings Pediatric patients with SARS-CoV-2 generally have mild illness; however, intensive care is required in about 20–30% of hospitalized children with COVID-19 and an even higher proportion in those with MIS-C. Increased rates of thrombosis have been observed in adults hospitalized with COVID-19, and clinical trials have attempted to optimize thromboprophylaxis. There is significant variability in the estimated incidence of thrombosis in pediatric patients (0–27%) because of variation in patient populations and study design. Multiple studies demonstrate an increased rate of thrombosis compared with baseline in hospitalized pediatric patients. Few studies have evaluated risk factors for thrombosis, but critical illness, older age, and other known thrombosis risk factors appear to increase the risk. Thromboprophylaxis strategies are inconsistent, with little evidence of efficacy but few reports of major bleeding. Summary Critically ill children with SARS-CoV-2-related illnesses are at increased risk of thrombosis. Thromboprophylaxis should be considered in select patients with COVID-19 or MIS-C, though the optimal strategy is not yet known. More data is required to guide practice to prevent thrombosis in this population.

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Enoxaparin Thromboprophylaxis in Children Hospitalized for COVID-19: A Phase 2 Trial

Cited by 24 publications

References 52 publications

Current practices in pediatric hospital‐acquired thromboembolism: Survey of the Children's Hospital Acquired Thrombosis (CHAT) Consortium

Current practices in pediatric hospital‐acquired thromboembolism: Survey of the Children's Hospital Acquired Thrombosis (CHAT) Consortium

Good practice statements for antithrombotic therapy in the management of COVID‐19: Guidance from the SSC of the ISTH

Thrombotic events in critically ill children with coronavirus disease 2019 or multisystem inflammatory syndrome in children

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