Study Stopped
insufficient recruitment of patients and high costs associated with the purchase and blinding of study medication
Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma
Hepburn
Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin Versus Placebo in Burn Patients With Inhalation Trauma (Hepburn)
2 other identifiers
interventional
13
3 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2013
Typical duration for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2013
CompletedFirst Posted
Study publicly available on registry
January 23, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 16, 2022
February 1, 2022
3 years
January 16, 2013
February 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of ventilator-free days at day 28
The number of ventilator-free days is defined as the number of days a patient is breathing without assist of a ventilator during the first 28 days; thus, the patient must be free of mechanical ventilation for 24 hours to have one ventilator-free day; if after successful detubation the patient requires a reintubation due to a surgical procedure, this reintubation will not count as a ventilator day - however, the day(s) will be counted as ventilator day(s) if mechanical ventilation is prolonged after surgery due to respiratory insufficiency.
at day 28
Secondary Outcomes (3)
Clinical outcome parameters
daily or at day 28 and day 90
Laboratory outcome parameters
Blood and lavage samples: on admission day and every other day for a maximum period of 14 days
Safety parameters
daily, for a maximum period of 28 days
Study Arms (2)
unfractionated heparin
EXPERIMENTAL25.000 IU/5 ml, will be nebulized 4 hourly (i.e. 6 times daily)
placebo
PLACEBO COMPARATORSterile sodium chloride (NaCl 0.9%, Pfizer), in 5 ml, will be nebulized every 4 hours (i.e. 6 times daily)
Interventions
nebulized 6 times daily, daily dose 150.000 IU for the maximum duration of 14 days
Placebo: Sterile saline nebulized 6 times daily for the maximum duration of 14 days
Eligibility Criteria
You may qualify if:
- Informed consent
- Age \> 18 years
- Need for invasive mechanical ventilation
- Confirmed inhalation trauma (bronchoscopically)
You may not qualify if:
- \> 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
St Vincent's Hospital
Melbourne, Victoria, 3065, Australia
University Hospital, Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
University Hospital Gasthuisberg - Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Ziekenhuis Netwerk Antwerpen- Stuivenberg
Antwerp, 2000, Belgium
Academic Medical Center
Amsterdam, North Holland, 1105 AZ, Netherlands
Red Cross Hospital, Beverwijk, the Netherlands
Beverwijk, North Holland, 1942 LE, Netherlands
Maasstad Hospital
Rotterdam, South Holland, 3079 DZ, Netherlands
Martini Hospital
Groningen, 9728 NT, Netherlands
Related Publications (1)
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.
PMID: 24661817DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcus J Schultz, MD-PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
January 16, 2013
First Posted
January 23, 2013
Study Start
October 1, 2013
Primary Completion
October 1, 2016
Study Completion
December 1, 2017
Last Updated
February 16, 2022
Record last verified: 2022-02