Multiple TraumaPhase 3TRAUMADORNASENCT03368092
Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma
A Phase 3 study testing Dornase Alfa Inhalant Solution [Pulmozyme] in people with Multiple Trauma and Respiratory Distress Syndrome, Adult, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Trauma, Respiratory Distress Syndrome, Adult
- What is being tested?
- Dornase Alfa Inhalant Solution [Pulmozyme]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2019to 1 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital, Strasbourg, france
Strasbourg, 67000
Julien Pottecher, MD, 03 88 12 70 95, julien.pottecher@chru-strasbourg.fr
About this study
Official title: 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
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).
Read more
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
- Being tested
- Dornase Alfa Inhalant Solution [Pulmozyme], Placebos
- Keywords
- severe trauma, acute respiratory distress syndrome, damage-associated molecular patterns, neutrophil extracellular traps, dornase alfa
- Medical subject headings
- Multiple Trauma, Respiratory Distress Syndrome, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dornase Alfa Inhalant Solution [Pulmozyme]Drug
Dornase alfa (Pulmozyme®, Roche 2500U, 2,5mL) given by aerosol in the respiratory circuit (Aerogen solo®) within 6h at day 1 and 24 hours after on day 2.
PlacebosDrug
NaCl 0,9%, given by aerosol in the respiratory circuit within 6h at day 1 and 24 hours after on day 2.
| Study group | Role | What they receive |
|---|---|---|
| Dornase alfa | Experimental | Dornase alfa (Pulmozyme®, Roche 2500U, 2,5mL) given by aerosol in the respiratory circuit (Aerogen solo®) within 6h at day 1 and 24 hours after on day 2. Receives: Drug: Dornase Alfa Inhalant Solution [Pulmozyme] |
| Placebo | Placebo comparator | NaCl 0,9%, given by aerosol in the respiratory circuit within 6h at day 1 and 24 hours after on day 2. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the incidence of moderate to severe ARDS (PaO2/FiO2 < 200, according to the Berlin definition [ARDS definition task force et al. JAMA 2015; 307(23): 2526-2533]) in severe trauma patients (Injury Severity Score > 15).
Measured: Day 0 to Day 7
Secondary outcomes (7)
Static lung compliance [mL/cmH2O]
Measured: Day 0 to Day 7
Duration of mechanical ventilation [hours]
Measured: Day 0 to Day 7
Length of ICU stay [hours]
Measured: Day 0 to Day 7
Length of stay in the hospital [days]
Measured: Day 0 to Day 7
Incidence of multi-organ failure
according SOFA (Sepsis-related Organ Failure Assessment) to quantify organ dysfunction
Measured: Day 0 to Day 7
Incidence of Ventilator-Associated Pneumonia (VAP)
Measured: Day 0 to Day 7
Mortality on day 28
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start4 Mar 2019
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368092
- Sponsor's protocol ID
- 6998
- Acronym
- TRAUMADORNASE
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2017
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pottecher J, Noll E, Borel M, Audibert G, Gette S, Meyer C, Gaertner E, Legros V, Carapito R, Uring-Lambert B, Sauleau E, Land WG, Bahram S, Meyer A, Geny B, Diemunsch P. Protocol for TRAUMADORNASE: a prospective, randomized, multicentre, double-blinded, placebo-controlled clinical trial of aerosolized dornase alfa to reduce the incidence of moderate-to-severe hypoxaemia in ventilated trauma patients. Trials. 2020 Mar 18;21(1):274. doi: 10.1186/s13063-020-4141-6.
PubMed 32183886
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03368092
- Acronym / sponsor ID
- TRAUMADORNASE / 6998
- Keywords
- severe trauma, acute respiratory distress syndrome, damage-associated molecular patterns, neutrophil extracellular traps, dornase alfa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dornase alfa | Experimental | Drug: Dornase Alfa Inhalant Solution [Pulmozyme]Dornase alfa (Pulmozyme®, Roche 2500U, 2,5mL) given by aerosol in the respiratory circuit (Aerogen solo®) within 6h at day 1 and 24 hours after on day 2. |
| Placebo | Placebo comparator | Drug: PlacebosNaCl 0,9%, given by aerosol in the respiratory circuit within 6h at day 1 and 24 hours after on day 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (>18) patient of either sex affiliated to the National Health Service
Key exclusion criteria (5 listed)
- Pregnancy or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dornase Alfa Inhalant Solution [Pulmozyme]Dornase alfa (Pulmozyme®, Roche 2500U, 2,5mL) given by aerosol in the respiratory circuit (Aerogen solo®) within 6h at day 1 and 24 hours after on day 2. | Drug | Dornase alfa |
| PlacebosNaCl 0,9%, given by aerosol in the respiratory circuit within 6h at day 1 and 24 hours after on day 2. | Drug | Placebo |
Primary outcome
The primary endpoint is the incidence of moderate to severe ARDS (PaO2/FiO2 < 200, according to the Berlin definition [ARDS definition task force et al. JAMA 2015; 307(23): 2526-2533]) in severe trauma patients (Injury Severity Score > 15).
Time frame: Day 0 to Day 7
7 secondary outcomes
Static lung compliance [mL/cmH2O]
Time frame: Day 0 to Day 7
Duration of mechanical ventilation [hours]
Time frame: Day 0 to Day 7
Length of ICU stay [hours]
Time frame: Day 0 to Day 7
Length of stay in the hospital [days]
Time frame: Day 0 to Day 7
Incidence of multi-organ failure
Time frame: Day 0 to Day 7
Incidence of Ventilator-Associated Pneumonia (VAP)
Time frame: Day 0 to Day 7
Mortality on day 28
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 32183886Pottecher J, Noll E, Borel M, Audibert G, Gette S, Meyer C, Gaertner E, Legros V, Carapito R, Uring-Lambert B, Sauleau E, Land WG, Bahram S, Meyer A, Geny B, Diemunsch P. Protocol for TRAUMADORNASE: a prospective, randomized, multicentre, double-blinded, placebo-controlled clinical trial of aerosolized dornase alfa to reduce the incidence of moderate-to-severe hypoxaemia in ventilated trauma patients. Trials. 2020 Mar 18;21(1):274. doi: 10.1186/s13063-020-4141-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dornase Alfa Inhalant Solution [Pulmozyme] in people with Multiple Trauma and Respiratory Distress Syndrome, Adult, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien POTTECHER, MD (+33 388127095, julien.pottecher@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the incidence of moderate to severe ARDS (PaO2/FiO2 < 200, according to the Berlin definition [ARDS definition task force et al. JAMA 2015; 307(23): 2526-2533]) in severe trauma patients (Injury Severity Score > 15). (time frame: Day 0 to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03368092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.