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Clinical Care of Pediatric Patients with or at-risk of the post-thrombotic syndrome: Guidance from the Pediatric and Neonatal Thrombosis and Haemostasis Subcommittee of the ISTH
The incidence of pediatric venous thromboembolism (VTE) is rising. Although VTE is perceived as an acute event, chronic complications such as a lack of thrombus resolution, recurrence, postthrombotic syndrome (PTS), and postpulmonary embolism syndrome are now better recognized. PTS, a form of chronic venous insufficiency, develops in one-third of children after extremity deep venous thrombosis (DVT). PTS is clinically significant because of its impact on functioning and health-related quality of life (HR-QoL).
There is scarce evidence to guide the management of pediatric PTS, resulting in heterogeneous clinical management. Additionally, the presentation of pediatric PTS is variable over time, leading to underrecognition and variation in care. This led the Post-Thrombotic Sequelae Working Group (WG) of the Scientific and Standardization Subcommittee on Pediatric and Neonatal Thrombosis and Haemostasis within the International Society on Thrombosis and Haemostasis to launch a project to provide guidance on key areas related to the care of pediatric PTS. This document summarizes the available evidence on PTS risk factors, PTS evaluation tools, prevention, and the treatment of pediatric PTS to guide clinicians regarding PTS prevention and treatment for children with or at risk of PTS following limb DVT.
Effect of Anticoagulant Therapy for 6 Weeks vs 3 Months on Recurrence and Bleeding Events in Patients Younger Than 21 Years of Age With Provoked Venous Thromboembolism
Among patients younger than 21 years of age with acute provoked venous thromboembolism, is a 6-week duration of anticoagulant therapy noninferior to a conventional 3-month duration?
In this randomized clinical trial that included 417 patients with provoked venous thromboembolism, anticoagulant therapy for 6 weeks vs 3 months resulted in symptomatic recurrent venous thromboembolism in 0.66% vs 0.70%, respectively, and clinically relevant bleeding events in 0.65% vs 0.70% within 1 year. The differences met the criteria for noninferiority.
Among patients younger than 21 years of age with provoked venous thromboembolism, anticoagulant therapy for 6 weeks compared with 3 months met noninferiority based on a combination of recurrent venous thromboembolism risk and bleeding risk.
Physical activity in children at risk of postthrombotic sequelae: a pilot randomized controlled trial
Increased physical activity is protective against worsening of postthrombotic syndrome (PTS) in adults. We assessed patient eligibility, consent, adherence, and retention rates in a pilot trial of prescribed physical activity following venous thromboembolism (VTE) in children. Secondary objectives were to describe the within-subject changes in PTS, quality of life, and coagulation biomarkers before and after the intervention in each group. We enrolled and randomized patients between 7 and 21 years of age to the physical activity group or the standard care (education-only) group in a 1:1 allocation ratio. The physical activity group wore a Fitbit for 4 weeks to determine habitual activity and then increased activity over an 8-week “active” period, followed by a 4-week “do-as-you-wish” period. Two hundred thirty-five children were diagnosed with VTE; 111 patients were screened, of whom 40 (36%) met study eligibility criteria. Of these, 23 (57%) consented to participate and were randomized (Fitbit,11; standard group, 12). The trial was of greater interest to overweight and obese children, as they comprised 83% of consented patients. Only 33% adhered to the activity prescription, and 65% (15/23) completed the trial. The PTS scores (P = .001) improved in the physical activity group compared with the education-only group. It is feasible to enroll and randomize pediatric VTE patients to a prescribed physical activity regimen 3 months following VTE. Metrics for adherence to enhanced physical activity and retention were not met. These results provide the rationale to explore low adherence and retention rates before moving forward with a larger trial of exercise training following VTE. This trial was registered at www.clinicaltrials.gov as #NCT03075761.
Hasan R, Hanna M, Malone K, Zhang S, Sarode R, Journeycake J, Zia A. Physical activity in children at risk of post-thrombotic sequelae: a pilot randomized controlled trial. Blood Advances. 2020 Aug 11:4(15):3767-3775
Increased physical activity is protective against worsening of postthrombotic syndrome (PTS) in adults. We assessed patient eligibility, consent, adherence, and retention rates in a pilot trial of prescribed physical activity following venous thromboembolism (VTE) in children. Secondary objectives were to describe the within-subject changes in PTS, quality of life, and coagulation biomarkers before and after the intervention in each group. We enrolled and randomized patients between 7 and 21 years of age to the physical activity group or the standard care (education-only) group in a 1:1 allocation ratio. The physical activity group wore a Fitbit for 4 weeks to determine habitual activity and then increased activity over an 8-week "active" period, followed by a 4-week "do-as-you-wish" period. Two hundred thirty-five children were diagnosed with VTE; 111 patients were screened, of whom 40 (36%) met study eligibility criteria. Of these, 23 (57%) consented to participate and were randomized (Fitbit,11; standard group, 12). The trial was of greater interest to overweight and obese children, as they comprised 83% of consented patients. Only 33% adhered to the activity prescription, and 65% (15/23) completed the trial. The PTS scores (P = .001) improved in the physical activity group compared with the education-only group. It is feasible to enroll and randomize pediatric VTE patients to a prescribed physical activity regimen 3 months following VTE. Metrics for adherence to enhanced physical activity and retention were not met. These results provide the rationale to explore low adherence and retention rates before moving forward with a larger trial of exercise training following VTE. This trial was registered at www.clinicaltrials.gov as #NCT03075761.