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

Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin versus Placebo in Burn Patients with Inhalation Trauma - The Hepburn*study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39556

Enrollment

Registered

2012-12-04

Start date

2014-01-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute lung injury inhalationtrauma

Interventions

Nebulized heparin (25,000 IU) every 4 hrs every 24 hrs for the maximum duration of 14 days versus placebo (NaCl 0.9%)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - > 36 hours after trauma - Receiving invasive ventilation > 24 hours - Expected duration of mechanical ventilation 72 hours - Total body surface area (TBSA) > 60% - Witnessed or proven aspiration (i.e., confirmed by bronchoscopy)

Design outcomes

Primary

Measure	Time frame
Number of ventilator-free days during the first 28 days after inclusion.	—

Secondary

Measure	Time frame
- clinical outcome parameters such as Lung Injury Score (LIS), ICU length-of-stay (LOS), 28- and 90-day mortality, incidence of pneumonia (CDC criteria) and number of bronchoscopies performed to remove foreign particles and accumulated secretions - pulmonary coagulation and fibrinolysis as reflected by tissue factor (TF), activated factor VII (FVIIa) antithrombin (AT), thrombin-antithrombin complexes (TATc) and activated protein C (APC), plasminogen activator activity (PAA), tissue plasminogen activator (tPA), urokinase plasminogen activator (uPA) and plasminogen activator inhibitor 1 (PAI1), and FDP in BALF - pulmonary inflammation as reflected by IL1 beta, IL*6, IL-8, IL-10, TNF-alpha, VEGF and TGF-beta - safety of nebulized heparin, as reflected by activated partial thromboplastin (aPTT) time, prothrombin time (PT) and blood thrombocyte count	—

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)