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New treatment option for Multiple Trauma
Official title Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma
ClinicalTrials.gov ID: NCT03368092
What this study is testing
What is Dornase Alfa Inhalant Solution [Pulmozyme]?
Dornase Alfa Inhalant Solution [Pulmozyme] is an investigational medicine, being studied as a potential treatment for multiple trauma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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 for an expected duration \> 48h
- Admitted in the ICU
- Signed informed consent from the patient's relative
You likely can't join if
- 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
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 for an expected duration \> 48h
- Admitted in the ICU
- Signed informed consent from the patient's relative
- Patient equipped with an indwelling arterial catheter
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.