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
| Autor: | Velma Marzinotto, Patricia Massicotte, Maureen Andrew, Barbara Szechtman, Karen Shields, Jim A. Julian, Michael Gent |
|---|---|
| Rok vydání: | 2003 |
| Předmět: |
medicine.medical_specialty
Adolescent medicine.drug_class International Cooperation Low molecular weight heparin Administration Oral law.invention Randomized controlled trial law Internal medicine Thromboembolism medicine Humans Thrombolytic Therapy cardiovascular diseases Child Venous Thrombosis Dalteparin sodium business.industry Heparin Infant Hematology Odds ratio Heparin Low-Molecular-Weight medicine.disease Reviparin sodium Surgery Pulmonary embolism Clinical trial Exact test Treatment Outcome Child Preschool Drug Therapy Combination Warfarin business Pulmonary Embolism medicine.drug |
| Zdroj: | Thrombosis research. 109(2-3) |
| ISSN: | 0049-3848 |
| Popis: | Objective(s): 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. Study design: 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. |
| Databáze: | OpenAIRE |
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