Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin Versus Placebo in Burn Patients With Inhalation Trauma (Hepburn)
Overview
- Phase
- Phase 3
- Intervention
- unfractionated heparin
- Conditions
- Inhalation Injury
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Enrollment
- 13
- Locations
- 8
- Primary Endpoint
- Number of ventilator-free days at day 28
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Prof. Dr. Marcus J. Schultz
Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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%
Arms & Interventions
unfractionated heparin
25.000 IU/5 ml, will be nebulized 4 hourly (i.e. 6 times daily)
Intervention: unfractionated heparin
placebo
Sterile sodium chloride (NaCl 0.9%, Pfizer), in 5 ml, will be nebulized every 4 hours (i.e. 6 times daily)
Intervention: placebo
Outcomes
Primary Outcomes
Number of ventilator-free days at day 28
Time Frame: 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.
Secondary Outcomes
- 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)