Study of the effectiveness and safety of heparin inhalation to treat lung coagulation disturbances in burn patients with inhalation trauma.

• Conditions: Burn-associated inhalation trauma requiring intubation and mechanical ventilation.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2012-003289-42-NL
• Lead Sponsor: Academic Medical Center Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-21
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

- informed consent
- age > 18 years
- need for invasive mechanical ventilation
- clinical diagnosis of inhalation trauma: initially on basis of indirect observations, followed by confirmation through bronchoscopy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of nebulized heparin on duration of mechanical ventilation in burn patients with confirmed inhalation trauma.;Secondary Objective: • To determine the effect of nebulized heparin on relevant and frequently–used outcome parameters.<br>• To determine the effect of nebulized heparin on pulmonary coagulation and fibrinolysis, and pulmonary inflammation.<br>• To determine safety of nebulized heparin<br>;Primary end point(s): Number of ventilator-free days during the first 28 days after inclusion;Timepoint(s) of evaluation of this end point: Daily. <br>Moment of successful detubation (at least 24 hours free of mechanical ventilation) in a 28-day periode