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

• Published in: Trials Vol. 15; no. 1; p. 91
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 25-03-2014; BioMed Central
• Subjects: Administration, Inhalation; Anticoagulants - administration & dosage; Anticoagulants - adverse effects; Belgium; Clinical Protocols; Double-Blind Method; Heparin - administration & dosage; Heparin - adverse effects; Humans; Intubation, Intratracheal; Lung - drug effects; Lung - pathology; Lung - physiopathology; Nebulizers and Vaporizers; Netherlands; Recovery of Function; Research Design; Respiration; Respiration, Artificial; Smoke Inhalation Injury - diagnosis; Smoke Inhalation Injury - physiopathology; Smoke Inhalation Injury - therapy; Study Protocol; Time Factors; Treatment Outcome; Ventilator Weaning; Belgium; Netherlands
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/1745-6215-15-91

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.
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.
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.
NCT01773083 (http://www.clinicaltrials.gov), registered on 16 January 2013.Recruiting. Randomisation commenced on 1 January 2014.