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Open Access Study protocol

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 Glas12*, Johannes Muller3, Jan M Binnekade2, Berry Cleffken4, Kirsten Colpaert5, Barry Dixon6, Nicole P Juffermans12, Paul Knape7, Marcel M Levi8, Bert G Loef9, David P Mackie7, Manu Malbrain10, Marcus J Schultz12 and Koenraad F van der Sluijs1

Author Affiliations

1 Laboratory of Experimental Intensive Care and Anesthesiology (L · E · I C · A), Department of Intensive Care Medicine, Academic Medical Center, M0-210, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands

2 Department of Intensive Care Medicine, Academic Medical Center, Amsterdam, the Netherlands

3 Department of Intensive Care, University Hospital Gasthuisberg, Leuven, Belgium

4 Department of Intensive Care, Maasstad Hospital, Rotterdam, the Netherlands

5 Department of Intensive Care, Ghent University Hospital, Ghent, Belgium

6 Department of Intensive Care, St Vincent’s Hospital, Melbourne, Australia

7 Department of Intensive Care, Red Cross Hospital, Beverwijk, the Netherlands

8 Department of Internal Medicine, Academic Medical Center, Amsterdam, the Netherlands

9 Department of Intensive Care, Martini Hospital, Groningen, the Netherlands

10 Department of Intensive Care, Ziekenhuis Netwerk Antwerpen - Stuivenberg, Antwerp, Belgium

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Trials 2014, 15:91  doi:10.1186/1745-6215-15-91

Published: 25 March 2014

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.

Trial registration

NCT01773083 (http://www.clinicaltrials.gov webcite), registered on 16 January 2013.

Recruiting. Randomisation commenced on 1 January 2014.

Keywords:
Inhalation trauma; Pulmonary coagulopathy; Nebulization; Heparin; Mechanical ventilation