Ongoing Clinical Trials for Psychological Trauma
Currently, there is 1 ongoing clinical trial focused on treating complications related to severe physical trauma. This trial is investigating whether an inhaled medication called dornase alfa can help prevent serious lung problems in trauma patients who require intensive care and breathing support.
Clinical trial locations
Study on Dornase Alfa and Placebo to Reduce ARDS in Ventilated Trauma Patients in ICU
This clinical trial is being conducted in France and focuses on patients who have experienced severe physical injuries, particularly those requiring intensive care and mechanical breathing support. The study aims to determine whether an inhaled medication called dornase alfa can help reduce the risk of developing a serious lung condition known as acute respiratory distress syndrome (ARDS).
Main inclusion criteria:
- Adults over 18 years old
- Have experienced severe trauma with an Injury Severity Score greater than 15, meaning they have sustained serious injuries affecting multiple body parts
- Require mechanical ventilation (breathing machine support) for more than 48 hours
- Have been admitted to the intensive care unit within 6 hours of hospital arrival, or within 18 hours if surgery or bleeding control procedures were performed first
- Have an arterial catheter in place for monitoring blood pressure and taking blood samples
- A family member must provide informed consent on behalf of the patient
- Women of childbearing age must have a negative pregnancy test
Main exclusion criteria:
- Patients without severe trauma
- Patients outside the specified age range
- Those not requiring intensive care hospitalization
- Patients with an Injury Severity Score of 15 or below
- Those not at risk of developing ARDS
- Patients not part of the selected vulnerable population groups
Focus and goal of the trial:
The primary goal of this study is to evaluate whether early administration of dornase alfa can reduce the occurrence of moderate to severe ARDS during the first week following severe trauma. ARDS is a life-threatening lung condition where fluid builds up in the air sacs, making it extremely difficult to breathe and limiting oxygen supply to vital organs. The trial will monitor patients closely during their first 7 days after injury, measuring the severity of lung function using the PaO2/FiO2 ratio, which indicates how well oxygen is being absorbed by the blood.
Investigational drug:
Dornase alfa is the medication being tested in this trial. It is administered through inhalation directly into the airways using a nebulizer, which converts the liquid medication into a fine mist. Dornase alfa works by breaking down DNA present in thick mucus that accumulates in the lungs, making the mucus thinner and easier to clear from the airways. This mechanism may help improve lung function and potentially prevent the development of ARDS in critically injured patients. The medication will be compared against a placebo to determine its effectiveness.
The study is expected to conclude by September 2027, and results will provide valuable information about whether this approach can improve outcomes for trauma patients in intensive care settings.
Summary
Currently, there is one active clinical trial addressing complications of severe physical trauma, specifically focusing on preventing serious lung problems in intensive care patients. This trial is taking place exclusively in France and represents an important investigation into early intervention strategies for trauma patients requiring mechanical ventilation.
The study focuses specifically on dornase alfa, a mucolytic medication that helps thin and clear mucus from the airways. This targeted approach aims to address one of the most serious complications that can occur in severely injured patients—acute respiratory distress syndrome—which can be life-threatening and requires intensive medical support.
The trial design includes careful patient selection based on injury severity scores and timing of intensive care admission, ensuring that the medication is tested in patients most likely to benefit from early intervention. The research is expected to provide insights that could potentially improve standard care protocols for trauma patients in intensive care units worldwide.