Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-04 @ 3:42 PM
Study NCT ID:
NCT03368092
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2017-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma
Sponsor:
University Hospital, Strasbourg, France
Organization:
Study Overview
Official Title:
A Prospective, Randomized Multicenter, Double Blind Clinical Trial Comparing Inhaled Dornase Alfa and Its Placebo to Reduce the Incidence of Moderate to Severe ARDS in Ventilated Trauma Patients in the Intensive Care Unit
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAUMADORNASE
Brief Summary:
Severe hypoxemia following trauma may happen in many circumstances (aspiration, ventilation-associated pneumonia, lung contusion...), most of which are not exclusively associated with a direct injury to the lungs. Severe trauma and associated musculoskeletal injuries result in the acute release of Damage-Associated Molecular Patterns (DAMPs) in plasma, many of which are made of nucleic acids. DAMPs then bind leukocytes and trigger NETosis (Neutrophil Extracellular Traps), the release of nuclear material coated with proteolytic enzymes, which ultimately promotes remote lung injury and acute respiratory distress syndrome (ARDS).
Considering that many DAMPs and all NETs are made of nucleic acids, we hypothesize that dornase alfa, a commercially available recombinant desoxyribonuclease (DNAse) could reduce DAMPs and NETs-induced lung injury in severe trauma patients under mechanical ventilation in the intensive care unit (ICU).
The primary objective is to demonstrate a reduction in the incidence of moderate to severe ARDS in severe trauma patients during the first seven ICU days from 45% to 30% by providing aerosolized dornase alfa once during the first two consecutive ICU days and compared to equivalent provision of placebo (NaCl 0,9%).
The secondary objectives are to demonstrate, by using aerosolized dornase alfa compared to placebo:
* an improvement in static lung compliance
* a reduction in mechanical ventilation duration / an increase in ventilation-free ICU days
* a reduction in the length of ICU stay
* a reduction in the hospital length of stay
* a reduction in multi-organ failure
* a reduction in ventilator-associated pneumonia (VAP)
* a reduction in mortality at day 28
Considering that many DAMPs and all NETs are made of nucleic acids, we hypothesize that dornase alfa, a commercially available recombinant desoxyribonuclease (DNAse) could reduce DAMPs and NETs-induced lung injury in severe trauma patients under mechanical ventilation in the intensive care unit (ICU).
The primary objective is to demonstrate a reduction in the incidence of moderate to severe ARDS in severe trauma patients during the first seven ICU days from 45% to 30% by providing aerosolized dornase alfa once during the first two consecutive ICU days and compared to equivalent provision of placebo (NaCl 0,9%).
The secondary objectives are to demonstrate, by using aerosolized dornase alfa compared to placebo:
* an improvement in static lung compliance
* a reduction in mechanical ventilation duration / an increase in ventilation-free ICU days
* a reduction in the length of ICU stay
* a reduction in the hospital length of stay
* a reduction in multi-organ failure
* a reduction in ventilator-associated pneumonia (VAP)
* a reduction in mortality at day 28
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: