Using inhaled dornase alpha to improve breathing after severe trauma
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
Run by University Hospital, Strasbourg, France · NCT03368092 · Data updated 2026-11-12
This study is testing if inhaled dornase alpha can help adults with severe lung injury from trauma breathe better while they are on a ventilator in the ICU.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | March 4, 2019 |
| Main results expected | September 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT03368092 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with severe trauma and an Injury Severity Score greater than 15, who are expected to be on mechanical ventilation for more than 48 hours.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have known contraindications to dornase alpha will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of inhaled dornase alpha, a recombinant enzyme, to reduce lung injury caused by severe trauma and associated respiratory distress syndrome in adult patients. The study focuses on patients who are mechanically ventilated in the ICU and aims to demonstrate that dornase alpha can decrease the levels of damaging molecules released during trauma. By targeting neutrophil extracellular traps and damage-associated molecular patterns, the trial seeks to improve respiratory outcomes in critically injured patients. Participants will be compared to a placebo group to assess the efficacy of the treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve respiratory function and outcomes for patients suffering from severe trauma.
How similar studies have gone: While the approach of using dornase alpha in this context is novel, similar studies targeting lung injury in trauma patients have shown promise.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (\>18) patient of either sex affiliated to the National Health Service * Severe trauma patient (either blunt or penetrating), Injury Severity Score \> 15 * Under mechanical ventilation for an expected duration \> 48h * Admitted in the ICU * Signed informed consent from the patient's relative * Patient equipped with an indwelling arterial catheter Exclusion Criteria: * Pregnancy or breast feeding * Opposition from the patient or his/her relatives * Protected major (Guardianship) * Contraindication to the use of dornase alfa * Known intolerance to dornase alfa
Where it's running
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University Hospital, Strasbourg, france
Strasbourg, France Recruiting
Study contacts
- Study coordinator: Julien POTTECHER, MD
- Email: julien.pottecher@chru-strasbourg.fr
- Phone: +33 388127095
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.