title: An open-label randomized controlled trial of low molecular weight heparin compared to heparin and coumadin for the treatment of venous thromboembolic events in children: the REVIVE trial.
abstract: OBJECTIVE
  Venous thromboembolic events (VTE) are serious complications in children and for which the standard of care, unfractionated heparin followed by oral anticoagulation (UFH/OA), is problematic. The objective of REVIVE was to compare the efficacy and safety of a low molecular weight heparin (reviparin-sodium) to UFH/OA for the treatment of VTE in children.
  
  
  METHODS
  This multicenter, open-label study, with blinded central outcome adjudication, randomized patients with objectively confirmed VTE to receive either reviparin-sodium or UFH/OA. Dose adjustments were made using nomograms. The efficacy outcome was based on recurrent VTE and death due to VTE during the 3-month treatment period. The safety outcomes were major bleeding, minor bleeding and death. Due to slow patient accrual, REVIVE was closed prematurely.
  
  
  RESULTS
  At 3 months, with reviparin-sodium, 2/36 patients (5.6%) had recurrent VTE or death compared to 4/40 patients (10.0%) receiving UFH/OA (odds ratio=0.53; 95% CI=(0.05, 4.00); Fisher's exact test: 2P=0.677). There were 7 major bleeds, 2/36 (5.6%) in the reviparin-sodium group and 5/40 (12.5%) in UFH/OA group (odds ratio=0.41; 95% confidence interval 0.04, 2.76); Fisher's exact test: P=0.435). There were 5 deaths during the study period, 1 (2.8%) in the reviparin-sodium group and 4 (10.0%) in the UFH/OA group. All five deaths were unrelated to VTE but one was due to an intracranial hemorrhage in the UFH/OA group.
  
  
  CONCLUSIONS
  Although limited by small sample size, REVIVE provides valuable information on the incidence of recurrent VTE, major bleeding and problematic issues associated with therapy of VTE in children.
authors.affiliation: Division of Hematology/Oncology, Department of Pediatrics, Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto, Ontario, Canada M5G 1X8. patricia.massicotte@sickkids.ca
authors.forename: Patricia
authors.initials: P
authors.lastname: Massicotte
authors.forename: Jim A
authors.initials: JA
authors.lastname: Julian
authors.forename: Michael
authors.initials: M
authors.lastname: Gent
authors.forename: Karen
authors.initials: K
authors.lastname: Shields
authors.forename: Velma
authors.initials: V
authors.lastname: Marzinotto
authors.forename: Barbara
authors.initials: B
authors.lastname: Szechtman
authors.forename: Maureen
authors.initials: M
authors.lastname: Andrew
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D006493:Heparin / Q000008:administration & dosage*; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007391:International Cooperation; D011655:Pulmonary Embolism / Q000188:drug therapy*; D013923:Thromboembolism / Q000188:drug therapy*; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000379:methods; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000188:drug therapy*; D014859:Warfarin / Q000008:administration & dosage*
chemical_list: D006495:Heparin, Low-Molecular-Weight; D014859:Warfarin; C094240:reviparin; D006493:Heparin