Using inhaled dornase alpha to improve breathing after severe trauma
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
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 |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT03368092 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant, breastfeeding, or have known contraindications to dornase alpha will not benefit from this study.
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 performed: While the approach of using dornase alpha in this context is novel, similar studies targeting lung injury in trauma patients have shown promise.
Eligibility criteria
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 this trial is running
Strasbourg
- University Hospital, Strasbourg, france — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Julien POTTECHER, MD
- Email: julien.pottecher@chru-strasbourg.fr
- Phone: +33 388127095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.