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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

Gerie J Glas, Johannes Muller, Jan M Binnekade, Berry Cleffken, Kirsten Colpaert UGent, Barry Dixon, Nicole P Juffermans, Paul Knape, Marcel Levi, Bert G Loef, et al. (2014) TRIALS. 15.
abstract
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.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
Pulmonary coagulopathy, Inhalation trauma, Nebulization, Heparin, Mechanical ventilation, ACUTE LUNG INJURY, RESPIRATORY-DISTRESS-SYNDROME, MECHANICALLY VENTILATED PATIENTS, IDIOPATHIC PULMONARY-FIBROSIS, CRITICALLY-ILL PATIENTS, SMOKE-INHALATION, COAGULATION, INFLAMMATION, MODEL, FIBRINOLYSIS
journal title
TRIALS
Trials
volume
15
article number
91
pages
11 pages
Web of Science type
Article
Web of Science id
000334868000001
JCR category
MEDICINE, RESEARCH & EXPERIMENTAL
JCR impact factor
1.731 (2014)
JCR rank
81/123 (2014)
JCR quartile
3 (2014)
ISSN
1745-6215
DOI
10.1186/1745-6215-15-91
language
English
UGent publication?
yes
classification
A1
copyright statement
I have retained and own the full copyright for this publication
id
5815516
handle
http://hdl.handle.net/1854/LU-5815516
date created
2015-01-23 09:15:30
date last changed
2016-12-21 15:42:49
@article{5815516,
  abstract     = {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.},
  articleno    = {91},
  author       = {Glas, Gerie J and Muller, Johannes and Binnekade, Jan M and Cleffken, Berry and Colpaert, Kirsten and Dixon, Barry and Juffermans, Nicole P and Knape, Paul and Levi, Marcel and Loef, Bert G and Mackie, David P and Malbrain, Manu and Schultz, Marcus J and van der Sluijs, Koenraad F},
  issn         = {1745-6215},
  journal      = {TRIALS},
  keyword      = {Pulmonary coagulopathy,Inhalation trauma,Nebulization,Heparin,Mechanical ventilation,ACUTE LUNG INJURY,RESPIRATORY-DISTRESS-SYNDROME,MECHANICALLY VENTILATED PATIENTS,IDIOPATHIC PULMONARY-FIBROSIS,CRITICALLY-ILL PATIENTS,SMOKE-INHALATION,COAGULATION,INFLAMMATION,MODEL,FIBRINOLYSIS},
  language     = {eng},
  pages        = {11},
  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},
  url          = {http://dx.doi.org/10.1186/1745-6215-15-91},
  volume       = {15},
  year         = {2014},
}

Chicago
Glas, Gerie J, Johannes Muller, Jan M Binnekade, Berry Cleffken, Kirsten Colpaert, Barry Dixon, Nicole P Juffermans, et al. 2014. “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.” Trials 15.
APA
Glas, G. J., Muller, J., Binnekade, J. M., Cleffken, B., Colpaert, K., Dixon, B., Juffermans, N. P., et al. (2014). 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. TRIALS, 15.
Vancouver
1.
Glas GJ, Muller J, Binnekade JM, Cleffken B, Colpaert K, Dixon B, et al. 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. TRIALS. 2014;15.
MLA
Glas, Gerie J, Johannes Muller, Jan M Binnekade, et al. “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.” TRIALS 15 (2014): n. pag. Print.