Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborator: Dutch Burns Foundation
• Treatments: Calcium heparin; Heparin

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)