Status:
RECRUITING
Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Multiple Trauma
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03368092
Start Date
March 4 2019
End Date
December 1 2027
Last Update
August 8 2025
Active Locations (1)
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1
University Hospital, Strasbourg, france
Strasbourg, France, 67000