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Table 4 Classification of risk factors for venous thrombosis at baseline

From: Rivaroxaban versus standard anticoagulation for acute venous thromboembolism in childhood. Design of the EINSTEIN-Jr phase III study

  Subgroup Requirement
Provoked by persistent risk factor
 Active cancer – n (%) • Hematologic malignancies
• Solid tumors
Diagnosed, or treated within 3 months, or presence of metastases
 Major organ disease – n (%) • Cardiac
• Gastrointestinal
• Renal
• Neurological
Exclude major infectious disease
 Major congenital venous anomaly – n (%)   Venous anomaly in relation to location of index event
 Known inherited thrombophilia – n (%)
• Antithrombin, protein C or protein S deficiency
• Factor V Leiden, or prothrombin mutation
• Homozygous
• Heterozygous
At baseline or confirmed after randomization
Acquired thrombophilia – n (%)   Antiphospholipid syndrome. At baseline or confirmed after randomization
Family history of venous thrombosis – n (%)   First degree (parent or sibling)
Morbid obesity – n (%)   Body mass index > 35 kg/m2
Provoked by transient risk factor
 Major surgery – n (%)   Timeframe: within 1 month
 Major trauma – n (%)   Timeframe: within 1 month
 Major infectious disease – n (%) • Systemic
• Local
Timeframe: within 1 month
Local infection in anatomical relation with index event
 Prolonged immobilization – n (%)   Timeframe: within 1 month
Duration immobilization > 1 week
 Central venous catheter – n (%)   Timeframe: within 1 month
Location of index event related to central venous catheter
 Use of estrogens or progestins – n (%)   
 Puerperium– n (%)   Puerperium ends 6 weeks after birth
Etiology of index venous thrombosis
 Unprovoked – n (%)
 Provoked by persistent risk factor – n (%)
 Provoked by transient risk factor – n (%)
 Provoked by persistent and transient risk factor – n (%)
  
Number of risk factors – n (%)
 0
 1
 ≥2