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TRAUMADORNASE 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
EU CTIS ID: 2024-512034-14-00
What this study is testing
To demonstrate the efficacy of early intratracheal administration of dornase alfa in reducing the incidence of moderate and severe acute respiratory distress syndrome (PaO2/FiO2 ratio ≤ 200 or SpO2/FiO2 ≤ 235 if SpO2 ≤ 97%) during the first 7 days post-traumatic in patients with severe trauma (ISS>15) and hospitalized in intensive care.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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. Extubation of the patient within the first 48 hours is not a reason for leaving the study, as the investigational treatment can be administered in a similar manner to the extubated patient.
- Admitted in the ICU for less than 6 hours (or less than 18 hours after arrival at the hospital[de-shocking] in the case of prior surgery or embolization)
- Signed informed consent from the patient's relative or emergency procedure
- Patient equipped with an indwelling arterial catheter
You likely can't join if
- Pregnancy or breast feeding
- Opposition from the patient or his/her relatives
- Protected major (Guardianship)
- Known intolerance to dornase alfa. Contraindication to the use of dornase alfa
- Ventilation by high frequency oscillations
- - Subject already included in an interventional study.
See the full eligibility 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. Extubation of the patient within the first 48 hours is not a reason for leaving the study, as the investigational treatment can be administered in a similar manner to the extubated patient.
- Admitted in the ICU for less than 6 hours (or less than 18 hours after arrival at the hospital[de-shocking] in the case of prior surgery or embolization)
- Signed informed consent from the patient's relative or emergency procedure
- Patient equipped with an indwelling arterial catheter
- - For a woman of childbearing age, negative blood pregnancy test
- Pregnancy or breast feeding
- Opposition from the patient or his/her relatives
- Protected major (Guardianship)
- Known intolerance to dornase alfa. Contraindication to the use of dornase alfa
- Ventilation by high frequency oscillations
- - Subject already included in an interventional study.
- - Treatment (current or previous) with dornase alfa
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.