TRAUMADORNASE 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

Phase 3

Recruiting

Conditions: severe trauma

Registration Number: 2024-512034-14-00

Lead Sponsor: Les Hopitaux Universitaires De Strasbourg

Brief Summary: To demonstrate the efficacy of early intratracheal administration of

dornase alfa in reducing the incidence of moderate and severe acute

respiratory distress syndrome (PaO2/FiO2 ratio ≤ 200 or SpO2/FiO2 ≤ 235 if SpO2 ≤ 97%) during the first 7

days post-traumatic in patients with severe trauma (ISS>15) and

hospitalized in intensive care.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 500

Inclusion 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. 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.

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)

Signed informed consent from the patient's relative or emergency procedure

Patient equipped with an indwelling arterial catheter

For a woman of childbearing age, negative blood pregnancy test

Exclusion Criteria

Pregnancy or breast feeding

Opposition from the patient or his/her relatives

Protected major (Guardianship)

Known intolerance to dornase alfa. Contraindication to the use of dornase alfa

Ventilation by high frequency oscillations

Subject already included in an interventional study.
Treatment (current or previous) with dornase alfa

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).		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).

Secondary Outcome Measures

Name	Time	Method
Length of ICU stay [hours]	Day 0 to Day 7
Static lung compliance [mL/cmH2O]	Day 0 to Day 7
Duration of mechanical ventilation [hours]	Day 0 to Day 7
Length of stay in the hospital [days]	Day 0 to Day 7
Incidence of multi-organ failure	Day 0 to Day 7	according SOFA (Sepsis-related Organ Failure Assessment) to quantify organ dysfunction
Mortality on day 28	Day 28
Incidence of Ventilator-Associated Pneumonia (VAP)	Day 0 to Day 7

Trial Locations

Locations (11): Assistance Publique Hopitaux De Paris
🇫🇷
Paris Cedex 13, France
CHRU De Nancy
🇫🇷
Nancy, France
Centre Hospitalier Universitaire De Montpellier
🇫🇷
Montpellier Cedex 5, France
Centre Hospitalier Universitaire De Lille
🇫🇷
Lille Cedex, France
Centre Hospitalier Universitaire Reims
🇫🇷
Reims Cedex, France
Centre Hospitalier Universitaire De Toulouse
🇫🇷
Toulouse, France
University Hospital Of Clermont-Ferrand
🇫🇷
Clermont Ferrand Cedex 1, France
Hospices Civils De Lyon
🇫🇷
Pierre-Benite, France
Centre Hospitalier Regional De Marseille
🇫🇷
Marseille, France
Centre Hospitalier Universitaire D'Angers
🇫🇷
Angers, France
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Assistance Publique Hopitaux De Paris
🇫🇷Paris Cedex 13, France
BOREL Marie
Site contact
0683345191
Marie.borel2@aphp.fr