Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-29 @ 12:19 PM
Study NCT ID:
NCT03368092
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2017-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009104', 'term': 'Multiple Trauma'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568813', 'term': 'dornase alfa'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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).', 'timeFrame': 'Day 0 to Day 7'}], 'secondaryOutcomes': [{'measure': 'Static lung compliance [mL/cmH2O]', 'timeFrame': 'Day 0 to Day 7'}, {'measure': 'Duration of mechanical ventilation [hours]', 'timeFrame': 'Day 0 to Day 7'}, {'measure': 'Length of ICU stay [hours]', 'timeFrame': 'Day 0 to Day 7'}, {'measure': 'Length of stay in the hospital [days]', 'timeFrame': 'Day 0 to Day 7'}, {'measure': 'Incidence of multi-organ failure', 'timeFrame': 'Day 0 to Day 7', 'description': 'according SOFA (Sepsis-related Organ Failure Assessment) to quantify organ dysfunction'}, {'measure': 'Incidence of Ventilator-Associated Pneumonia (VAP)', 'timeFrame': 'Day 0 to Day 7'}, {'measure': 'Mortality on day 28', 'timeFrame': 'Day 28'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe trauma', 'acute respiratory distress syndrome', 'damage-associated molecular patterns', 'neutrophil extracellular traps', 'dornase alfa'], 'conditions': ['Multiple Trauma', 'Respiratory Distress Syndrome, Adult']}, 'referencesModule': {'references': [{'pmid': '32183886', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nConsidering 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).\n\nThe 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%).\n\nThe secondary objectives are to demonstrate, by using aerosolized dornase alfa compared to placebo:\n\n* an improvement in static lung compliance\n* a reduction in mechanical ventilation duration / an increase in ventilation-free ICU days\n* a reduction in the length of ICU stay\n* a reduction in the hospital length of stay\n* a reduction in multi-organ failure\n* a reduction in ventilator-associated pneumonia (VAP)\n* a reduction in mortality at day 28'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult (\\>18) patient of either sex affiliated to the National Health Service\n\n * Severe trauma patient (either blunt or penetrating), Injury Severity Score \\> 15\n * Under mechanical ventilation for an expected duration \\> 48h\n * Admitted in the ICU\n * Signed informed consent from the patient's relative\n * Patient equipped with an indwelling arterial catheter\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n\n * Opposition from the patient or his/her relatives\n * Protected major (Guardianship)\n * Contraindication to the use of dornase alfa\n * Known intolerance to dornase alfa"}, 'identificationModule': {'nctId': 'NCT03368092', 'acronym': 'TRAUMADORNASE', 'briefTitle': 'Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '6998'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dornase alfa', 'description': '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.', 'interventionNames': ['Drug: Dornase Alfa Inhalant Solution [Pulmozyme]']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'NaCl 0,9%, given by aerosol in the respiratory circuit within 6h at day 1 and 24 hours after on day 2.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Dornase Alfa Inhalant Solution [Pulmozyme]', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Dornase alfa']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'NaCl 0,9%, given by aerosol in the respiratory circuit within 6h at day 1 and 24 hours after on day 2.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Pottecher, MD', 'role': 'CONTACT', 'email': 'julien.pottecher@chru-strasbourg.fr', 'phone': '03 88 12 70 95'}], 'facility': 'University Hospital, Strasbourg, france', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Julien POTTECHER, MD', 'role': 'CONTACT', 'email': 'julien.pottecher@chru-strasbourg.fr', 'phone': '+33 388127095'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}