An open-label randomized controlled trial of low molecular weight heparin for the prevention of central venous line-related thrombotic complications in children: the PROTEKT trial
| Autor: | Patricia Massicotte, Michael Gent, Jim A. Julian, Karen Shields, Maureen Andrew, Velma Marzinotto, Barbara Szechtman, Anthony K.C. Chan |
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| Rok vydání: | 2003 |
| Předmět: |
Male
medicine.medical_specialty Catheterization Central Venous Adolescent medicine.drug_class Low molecular weight heparin Peripherally inserted central catheter law.invention Randomized controlled trial law Internal medicine medicine Humans Thrombolytic Therapy Child Venous Thrombosis Intention-to-treat analysis Dalteparin sodium business.industry Infant Newborn Infant Hematology Odds ratio Heparin Low-Molecular-Weight medicine.disease Surgery Clinical trial Treatment Outcome Child Preschool Female business medicine.drug Post-thrombotic syndrome |
| Zdroj: | Thrombosis research. 109(2-3) |
| ISSN: | 0049-3848 |
| Popis: | Objective(s): Central venous lines (CVLs) are major risk factors for venous thromboembolism (VTE) in children. The objective of PROTEKT was to determine if a low molecular weight heparin (reviparin-sodium) safely prevents CVL-related VTE. Study design: This multi-center, open-label study, with blinded central outcome adjudication, randomized patients with new CVLs to twice-daily reviparin-sodium or standard care. The efficacy outcome was based on an exit venogram at Day 30 (+14 days), or earlier in case of CVL removal, or confirmed symptomatic VTE. The safety outcomes were major bleeding and death. Due to slow and restricted patient accrual, PROTEKT was closed prematurely. Results: With reviparin-sodium, 14.1% (11:78) of patients had VTE compared to 12.5% (10:80) of control patients (odds ratio=1.15; 95% confidence interval 0.42, 3.23); 2P=0.82). One patient had a major bleed and there were two deaths, all three events occurring in the standard care group. Conclusions: The use of reviparin-sodium for short-term prophylaxis of CVL-related VTE in children was safe but its efficacy remains unclear. Although underpowered, PROTEKT provided valuable information on event rates and predictors of CVL-related VTE. |
| Databáze: | OpenAIRE |
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