NCT03368092 Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma
| NCT ID | NCT03368092 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Multiple Trauma |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2019-03-04 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 500 participants in total. It began in 2019-03-04 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03368092 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03368092 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 500 participants.
Is NCT03368092 currently recruiting?
Yes, NCT03368092 is actively recruiting participants. Contact the research team at julien.pottecher@chru-strasbourg.fr for enrollment information.
Where is the NCT03368092 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT03368092 clinical trial?
NCT03368092 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 500 participants.