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

Les Hopitaux Universitaires De Strasbourg11 sites in 1 country500 target enrollmentMarch 4, 2019

DrugsSODIUM CHLORIDE PULMOZYME 2500 U/2,5 ml, solution pour inhalation par nébuliseur

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Les Hopitaux Universitaires De Strasbourg
Enrollment: 500
Locations: 11
Primary Endpoint: 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).
Status: Recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

euclinicaltrials.eu

Start Date

March 4, 2019

End Date

December 1, 2027

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Investigators

Sponsor

Les Hopitaux Universitaires De Strasbourg

Responsible Party

Principal Investigator

POTTECHER Julien

Scientific

Les Hopitaux Universitaires De Strasbourg

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).