Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma
- Conditions
- Inhalation InjuryBurn Injury
- Interventions
- Drug: placebo
- Registration Number
- NCT01773083
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
- Informed consent
- Age > 18 years
- Need for invasive mechanical ventilation
- Confirmed inhalation trauma (bronchoscopically)
- > 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo Sterile sodium chloride (NaCl 0.9%, Pfizer), in 5 ml, will be nebulized every 4 hours (i.e. 6 times daily) unfractionated heparin unfractionated heparin 25.000 IU/5 ml, will be nebulized 4 hourly (i.e. 6 times daily)
- Primary Outcome Measures
Name Time Method Number of ventilator-free days at day 28 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 Outcome Measures
Name Time Method Clinical outcome parameters daily or at day 28 and day 90 Clinical outcome parameters will include but not be restricted to: (a) length of stay (ICU and hospital); (b) mortality (28- and 90 days); (c) mortality (ICU and hospital); (d) daily Lung Injury Score (LIS); (e) daily Oxygenation Index (OI) ; (f) daily Sequential Organ Failure Assessment (SOFA)-scores ; (g) cumulative dosages of sedatives; (h) incidence of Ventilator-associated Pneumonia (VAP); (i) total number of bronchoscopy-guided cleaning of the larger airway
Laboratory outcome parameters Blood and lavage samples: on admission day and every other day for a maximum period of 14 days Levels of markers of coagulation and fibrinolysis in blood and lung lavage fluid, Levels of markers of inflammation in blood and lung lavage fluid, Biomarkers of lung injury in blood and lung lavage fluid
Safety parameters daily, for a maximum period of 28 days Safety parameters will include but not be restricted to: Occurrence of serious bleedings, any other transfusion of blood products - red cells and/or platelets and/or plasma, Confirmed Heparin induced thrombocytopenia, prolonged activated partial thromboplastin time (aPTT \> 150 seconds)
Trial Locations
- Locations (8)
Academic Medical Center
🇳🇱Amsterdam, Noord-Holland, Netherlands
Maasstad Hospital
🇳🇱Rotterdam, Zuid-Holland, Netherlands
University Hospital, Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
University Hospital Gasthuisberg - Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium
St Vincent's Hospital
🇦🇺Melbourne, Victoria, Australia
Ziekenhuis Netwerk Antwerpen- Stuivenberg
🇧🇪Antwerpen, Belgium
Martini Hospital
🇳🇱Groningen, Netherlands
Red Cross Hospital, Beverwijk, the Netherlands
🇳🇱Beverwijk, Noord-Holland, Netherlands