Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin versus Placebo in Burn Patients with Inhalation Trauma

Phase 3

Completed

• Conditions: acute lung injury; inhalationtrauma; 10038716

• Registration Number: NL-OMON39556
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- informed consent
- age > 18 years
- need for intubation and mechanical ventilation
- clinical diagnosis of inhalation trauma confirmed by bronchoscopy

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of ventilator-free days during the first 28 days after inclusion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- clinical outcome parameters such as Lung Injury Score (LIS), ICU<br /><br>length-of-stay (LOS), 28- and 90-day mortality, incidence of pneumonia (CDC<br /><br>criteria) and number of bronchoscopies performed to remove foreign particles<br /><br>and accumulated secretions<br /><br><br /><br>- pulmonary coagulation and fibrinolysis as reflected by tissue factor (TF),<br /><br>activated factor VII (FVIIa) antithrombin (AT), thrombin-antithrombin complexes<br /><br>(TATc) and activated protein C (APC), plasminogen activator activity (PAA),<br /><br>tissue plasminogen activator (tPA), urokinase plasminogen activator (uPA) and<br /><br>plasminogen activator inhibitor 1 (PAI*1), and FDP in BALF<br /><br><br /><br>- pulmonary inflammation as reflected by IL*1 beta, IL*6, IL-8, IL-10,<br /><br>TNF-alpha, VEGF and TGF-beta<br /><br><br /><br>- safety of nebulized heparin, as reflected by activated partial thromboplastin<br /><br>(aPTT) time, prothrombin time (PT) and blood thrombocyte count</p><br>