Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01773083




Registration number
NCT01773083
Ethics application status
Date submitted
16/01/2013
Date registered
23/01/2013
Date last updated
16/02/2022

Titles & IDs
Public title
Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma
Scientific title
Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin Versus Placebo in Burn Patients With Inhalation Trauma (Hepburn)
Secondary ID [1] 0 0
2012-003289-42
Secondary ID [2] 0 0
HepBurn
Universal Trial Number (UTN)
Trial acronym
Hepburn
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inhalation Injury 0 0
Burn Injury 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - unfractionated heparin
Treatment: Drugs - placebo

Experimental: unfractionated heparin - 25.000 IU/5 ml, will be nebulized 4 hourly (i.e. 6 times daily)

Placebo comparator: placebo - Sterile sodium chloride (NaCl 0.9%, Pfizer), in 5 ml, will be nebulized every 4 hours (i.e. 6 times daily)


Treatment: Drugs: unfractionated heparin
nebulized 6 times daily, daily dose 150.000 IU for the maximum duration of 14 days

Treatment: Drugs: placebo
Placebo: Sterile saline nebulized 6 times daily for the maximum duration of 14 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of ventilator-free days at day 28
Timepoint [1] 0 0
at day 28
Secondary outcome [1] 0 0
Clinical outcome parameters
Timepoint [1] 0 0
daily or at day 28 and day 90
Secondary outcome [2] 0 0
Laboratory outcome parameters
Timepoint [2] 0 0
Blood and lavage samples: on admission day and every other day for a maximum period of 14 days
Secondary outcome [3] 0 0
Safety parameters
Timepoint [3] 0 0
daily, for a maximum period of 28 days

Eligibility
Key inclusion criteria
* Informed consent
* Age > 18 years
* Need for invasive mechanical ventilation
* Confirmed inhalation trauma (bronchoscopically)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2017
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Oost-Vlaanderen
Country [2] 0 0
Belgium
State/province [2] 0 0
Vlaams-Brabant
Country [3] 0 0
Belgium
State/province [3] 0 0
Antwerpen
Country [4] 0 0
Netherlands
State/province [4] 0 0
Noord-Holland
Country [5] 0 0
Netherlands
State/province [5] 0 0
Zuid-Holland
Country [6] 0 0
Netherlands
State/province [6] 0 0
Groningen

Funding & Sponsors
Primary sponsor type
Other
Name
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Dutch Burns Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01773083
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Marcus J Schultz, MD-PhD
Address 0 0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01773083