DORNASE ALFA for Acute respiratory distress syndrome | Severe trauma

Inclusion criteria

• {"criterion_text":"- Adult (>18) patient of either sex affiliated to the National Health Service"}
• {"criterion_text":"- Severe trauma patient (either blunt or penetrating), Injury Severity Score > 15"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Signed informed consent from the patient's relative or emergency procedure"}
• {"criterion_text":"- Patient equipped with an indwelling arterial catheter"}
• {"criterion_text":"- For a woman of childbearing age, negative blood pregnancy test"}

Exclusion criteria

• {"criterion_text":"- Pregnancy or breast feeding"}
• {"criterion_text":"- Opposition from the patient or his/her relatives"}
• {"criterion_text":"- Protected major (Guardianship)"}
• {"criterion_text":"- Known intolerance to dornase alfa. Contraindication to the use of dornase alfa"}
• {"criterion_text":"- Ventilation by high frequency oscillations"}
• {"criterion_text":"- Subject already included in an interventional study."}
• {"criterion_text":"- Treatment (current or previous) with dornase alfa"}

Primary endpoints

• {"endpoint_text":"- Incidence of moderate to severe ARDS (PaO2/FiO2 ≤ 200 or SpO2/FiO2 ≤ 235 if SpO2 ≤ 97%), according to the 2024 global definition in severe trauma patients (Injury Severity Score > 15).","definition_or_measurement_approach":"Incidence measured during the first 7 days post-traumatic using the 2024 global definition: PaO2/FiO2 ≤ 200 or SpO2/FiO2 ≤ 235 if SpO2 ≤ 97% in patients with ISS > 15."}

Secondary endpoints

• {"endpoint_text":"- Demonstrate the efficacy of early intratracheal administration of dornase alfa to reduce: the incidence of ventilation acquired pneumonia","definition_or_measurement_approach":"Incidence of ventilation-acquired pneumonia (no further measurement detail provided in source)."}
• {"endpoint_text":"- Demonstrate the efficacy of early intratracheal administration of dornase alfa to reduce: the impact of multi organ failure","definition_or_measurement_approach":"Assessment of multi-organ failure incidence/impact (specific scoring/definition not provided in source)."}
• {"endpoint_text":"- Demonstrate the efficacy of early intratracheal administration of dornase alfa to reduce: The incidence of minimal respiratory distress syndromes (200 < PaO2/FiO2 ≤ 300 or SpO2/FiO2 comprised between 235 and 315 [235 < PaO2/FiO2 ≤ 315] if SpO2 ≤ 97%)","definition_or_measurement_approach":"Incidence measured using PaO2/FiO2 and SpO2/FiO2 thresholds as specified (200 < PaO2/FiO2 ≤ 300 or SpO2/FiO2 between 235 and 315 if SpO2 ≤ 97%)."}
• {"endpoint_text":"- Demonstrate the efficacy of early intratracheal administration of dornase alfa to reduce: the duration of mechanical ventilation (hours)","definition_or_measurement_approach":"Duration of mechanical ventilation measured in hours."}
• {"endpoint_text":"- Demonstrate the efficacy of early intratracheal administration of dornase alfa to reduce: the length of intensive care unit stay (hours)","definition_or_measurement_approach":"Length of ICU stay measured in hours."}
• {"endpoint_text":"- Demonstrate the efficacy of early intratracheal administration of dornase alfa to reduce: the length of hospital stay","definition_or_measurement_approach":"Length of hospital stay (days/hours not further specified)."}
• {"endpoint_text":"- Demonstrate the efficacy of early intratracheal administration of dornase alfa to reduce: the mortality on D30","definition_or_measurement_approach":"All-cause mortality assessed at day 30 post-enrolment."}
• {"endpoint_text":"- Assessment of the safety of administration of dornase alfa","definition_or_measurement_approach":"Safety assessment of dornase alfa administration (specific safety endpoints not detailed in source)."}

France

Earliest CTIS Part Ii Submission Date

14-05-2024

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

629

Number Of Sites

12

Number Of Participants

500

Primary sponsor

Full Name

Les Hopitaux Universitaires De Strasbourg

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France