Clinical trial NCT01773083: Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma
Official title: Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin Versus Placebo in Burn Patients With Inhalation Trauma (Hepburn)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Inhalation Injury
Burn Injury
Keywords: Inhalation trauma
pulmonary coagulopathy
heparin nebulization
mechanical ventilation
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Dutch Burns Foundation
First posted: 2013-01-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this international multi-center double-blind randomized placebo-controlled trial is to determine the effect of nebulized heparin, compared to placebo, on the number of ventilator-free days at day 28, in burn patients with confirmed inhalation trauma requiring mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age \> 18 years
* Need for invasive mechanical ventilation
* Confirmed inhalation trauma (bronchoscopically)

Exclusion Criteria:

* \> 36 hours after trauma
* Receiving invasive ventilation \> 24 hours
* Expected duration of mechanical ventilation \< 24 hours
* Chronic obstructive pulmonary disease GOLD stage III and IV
* Any history of pulmonary hemorrhage in the past 3 months
* Any history of significant bleeding disorder
* Known allergy to heparin, including heparin-induced thrombocytopenia
* Pregnancy or breast feeding
* Unlikely to survive for \> 72 hours
* Total body surface area (TBSA) \> 60%
* Witnessed or proven aspiration (i.e., confirmed by bronchoscopy)

Primary outcomes:
measure: Number of ventilator-free days at day 28
timeFrame: at day 28
Secondary outcomes:
measure: Clinical outcome parameters
timeFrame: daily or at day 28 and day 90
measure: Laboratory outcome parameters
timeFrame: Blood and lavage samples: on admission day and every other day for a maximum period of 14 days
measure: Safety parameters
timeFrame: daily, for a maximum period of 28 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Gent
country: Belgium
facility: University Hospital, Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg - Leuven
state: Vlaams-Brabant
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen- Stuivenberg
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
city: Beverwijk
country: Netherlands
facility: Red Cross Hospital, Beverwijk, the Netherlands
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Martini Hospital
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Marcus J Schultz, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glas GJ, Muller J, Binnekade JM, Cleffken B, Colpaert K, Dixon B, Juffermans NP, Knape P, Levi MM, Loef BG, Mackie DP, Malbrain M, Schultz MJ, van der Sluijs KF. 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 Mar 25;15:91. doi: 10.1186/1745-6215-15-91.