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HEPBURN - investigating the efficacy and safety of nebulized heparin versus placebo in burn patients with inhalation trauma: study protocol for a multi-center randomized controlled trial
BACKGROUND: Pulmonary coagulopathy is a hallmark of lung injury following inhalation trauma. Locally applied heparin attenuates lung injury in animal models of smoke inhalation. Whether local treatment with heparin benefits patients with inhalation trauma is uncertain. The present trial aims at comp...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3987885/ https://www.ncbi.nlm.nih.gov/pubmed/24661817 http://dx.doi.org/10.1186/1745-6215-15-91 |
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author | Glas, Gerie J Muller, Johannes Binnekade, Jan M Cleffken, Berry Colpaert, Kirsten Dixon, Barry Juffermans, Nicole P Knape, Paul Levi, Marcel M Loef, Bert G Mackie, David P Malbrain, Manu Schultz, Marcus J van der Sluijs, Koenraad F |
author_facet | Glas, Gerie J Muller, Johannes Binnekade, Jan M Cleffken, Berry Colpaert, Kirsten Dixon, Barry Juffermans, Nicole P Knape, Paul Levi, Marcel M Loef, Bert G Mackie, David P Malbrain, Manu Schultz, Marcus J van der Sluijs, Koenraad F |
author_sort | Glas, Gerie J |
collection | PubMed |
description | BACKGROUND: Pulmonary coagulopathy is a hallmark of lung injury following inhalation trauma. Locally applied heparin attenuates lung injury in animal models of smoke inhalation. Whether local treatment with heparin benefits patients with inhalation trauma is uncertain. The present trial aims at comparing a strategy using frequent nebulizations of heparin with standard care in intubated and ventilated burn patients with bronchoscopically confirmed inhalation trauma. METHODS: The Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized HEParin versus Placebo in BURN Patients with Inhalation Trauma (HEPBURN) is an international multi-center, double-blind, placebo-controlled, two-arm study. One hundred and sixteen intubated and ventilated burn patients with confirmed inhalation trauma are randomized to nebulizations of heparin (the nebulized heparin strategy) or nebulizations of normal saline (the control strategy) every four hours for 14 days or until extubation, whichever comes first. The primary endpoint is the number of ventilator-free days, defined as days alive and breathing without assistance during the first 28 days, if the period of unassisted breathing lasts for at least 24 consecutive hours. DISCUSSION: As far as the authors know, HEPBURN is the first randomized, placebo-controlled trial, powered to investigate whether local treatment with heparin shortens duration of ventilation of intubated and ventilated burn patients with inhalation trauma. TRIAL REGISTRATION: NCT01773083 (http://www.clinicaltrials.gov), registered on 16 January 2013. Recruiting. Randomisation commenced on 1 January 2014. |
format | Online Article Text |
id | pubmed-3987885 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-39878852014-04-16 HEPBURN - investigating the efficacy and safety of nebulized heparin versus placebo in burn patients with inhalation trauma: study protocol for a multi-center randomized controlled trial Glas, Gerie J Muller, Johannes Binnekade, Jan M Cleffken, Berry Colpaert, Kirsten Dixon, Barry Juffermans, Nicole P Knape, Paul Levi, Marcel M Loef, Bert G Mackie, David P Malbrain, Manu Schultz, Marcus J van der Sluijs, Koenraad F Trials Study Protocol BACKGROUND: Pulmonary coagulopathy is a hallmark of lung injury following inhalation trauma. Locally applied heparin attenuates lung injury in animal models of smoke inhalation. Whether local treatment with heparin benefits patients with inhalation trauma is uncertain. The present trial aims at comparing a strategy using frequent nebulizations of heparin with standard care in intubated and ventilated burn patients with bronchoscopically confirmed inhalation trauma. METHODS: The Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized HEParin versus Placebo in BURN Patients with Inhalation Trauma (HEPBURN) is an international multi-center, double-blind, placebo-controlled, two-arm study. One hundred and sixteen intubated and ventilated burn patients with confirmed inhalation trauma are randomized to nebulizations of heparin (the nebulized heparin strategy) or nebulizations of normal saline (the control strategy) every four hours for 14 days or until extubation, whichever comes first. The primary endpoint is the number of ventilator-free days, defined as days alive and breathing without assistance during the first 28 days, if the period of unassisted breathing lasts for at least 24 consecutive hours. DISCUSSION: As far as the authors know, HEPBURN is the first randomized, placebo-controlled trial, powered to investigate whether local treatment with heparin shortens duration of ventilation of intubated and ventilated burn patients with inhalation trauma. TRIAL REGISTRATION: NCT01773083 (http://www.clinicaltrials.gov), registered on 16 January 2013. Recruiting. Randomisation commenced on 1 January 2014. BioMed Central 2014-03-25 /pmc/articles/PMC3987885/ /pubmed/24661817 http://dx.doi.org/10.1186/1745-6215-15-91 Text en Copyright © 2014 Glas et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. |
spellingShingle | Study Protocol Glas, Gerie J Muller, Johannes Binnekade, Jan M Cleffken, Berry Colpaert, Kirsten Dixon, Barry Juffermans, Nicole P Knape, Paul Levi, Marcel M Loef, Bert G Mackie, David P Malbrain, Manu Schultz, Marcus J van der Sluijs, Koenraad F HEPBURN - investigating the efficacy and safety of nebulized heparin versus placebo in burn patients with inhalation trauma: study protocol for a multi-center randomized controlled trial |
title | HEPBURN - investigating the efficacy and safety of nebulized heparin versus placebo in burn patients with inhalation trauma: study protocol for a multi-center randomized controlled trial |
title_full | HEPBURN - investigating the efficacy and safety of nebulized heparin versus placebo in burn patients with inhalation trauma: study protocol for a multi-center randomized controlled trial |
title_fullStr | HEPBURN - investigating the efficacy and safety of nebulized heparin versus placebo in burn patients with inhalation trauma: study protocol for a multi-center randomized controlled trial |
title_full_unstemmed | HEPBURN - investigating the efficacy and safety of nebulized heparin versus placebo in burn patients with inhalation trauma: study protocol for a multi-center randomized controlled trial |
title_short | HEPBURN - investigating the efficacy and safety of nebulized heparin versus placebo in burn patients with inhalation trauma: study protocol for a multi-center randomized controlled trial |
title_sort | hepburn - investigating the efficacy and safety of nebulized heparin versus placebo in burn patients with inhalation trauma: study protocol for a multi-center randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3987885/ https://www.ncbi.nlm.nih.gov/pubmed/24661817 http://dx.doi.org/10.1186/1745-6215-15-91 |
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