Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma
Information source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Inhalation Injury; Burn Injury
Intervention: unfractionated heparin (Drug); placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Official(s) and/or principal investigator(s): Marcus J Schultz, MD-PhD, Principal Investigator, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.
Clinical Details
Official title: Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin Versus Placebo in Burn Patients With Inhalation Trauma (Hepburn)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of ventilator-free days at day 28
Secondary outcome: Clinical outcome parametersLaboratory outcome parameters Safety parameters
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Ziekenhuis Netwerk Antwerpen- Stuivenberg, Antwerpen 2000, Belgium
Martini Hospital, Groningen 9728 NT, Netherlands
Academic Medical Center, Amsterdam, Noord-Holland 1105 AZ, Netherlands
Red Cross Hospital, Beverwijk, the Netherlands, Beverwijk, Noord-Holland 1942 LE, Netherlands
University Hospital, Gent, Gent, Oost-Vlaanderen 9000, Belgium
St Vincent's Hospital, Melbourne, Victoria 3065, Australia
University Hospital Gasthuisberg - Leuven, Leuven, Vlaams-Brabant 3000, Belgium
Maasstad Hospital, Rotterdam, Zuid-Holland 3079 DZ, Netherlands
Additional Information
HEPBURN website
Starting date: October 2013
Last updated: July 22, 2015
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