About: 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

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About: 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 Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	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
Creator	Meyer, Christian Bahram, Seiamak Audibert, Gérard Pottecher, Julien Geny, Bernard Land, Walter Meyer, Alain Legros, Vincent Borel, Marie Carapito, Raphaël Diemunsch, Pierre Gaertner, Elisabeth Gette, Sébastien Noll, Eric Sauleau, Erik Uring-Lambert, Béatrice
Source	PMC
abstract	BACKGROUND: Acute respiratory distress syndrome continues to drive significant morbidity and mortality after severe trauma. The incidence of trauma-induced, moderate-to-severe hypoxaemia, according to the Berlin definition, could be as high as 45%. Its pathophysiology includes the release of damage-associated molecular patterns (DAMPs), which propagate tissue injuries by triggering neutrophil extracellular traps (NETs). NETs include a DNA backbone coated with cytoplasmic proteins, which drive pulmonary cytotoxic effects. The structure of NETs and many DAMPs includes double-stranded DNA, which prevents their neutralization by plasma. Dornase alfa is a US Food and Drug Administration-approved recombinant DNase, which cleaves extracellular DNA and may therefore break up the backbone of NETs and DAMPs. Aerosolized dornase alfa was shown to reduce trauma-induced lung injury in experimental models and to improve arterial oxygenation in ventilated patients. METHODS: TRAUMADORNASE will be an institution-led, multicentre, double-blinded, placebo-controlled randomized trial in ventilated trauma patients. The primary trial objective is to demonstrate a reduction in the incidence of moderate-to-severe hypoxaemia in severe trauma patients during the first 7 days from 45% to 30% by providing aerosolized dornase alfa as compared to placebo. The secondary objectives are to demonstrate an improvement in lung function and a reduction in morbidity and mortality. Randomization of 250 patients per treatment arm will be carried out through a secure, web-based system. Statistical analyses will include a descriptive step and an inferential step using fully Bayesian techniques. The study was approved by both the Agence Nationale de la Sécurité du Médicament et des Produits de Santé (ANSM, on 5 October 2018) and a National Institutional Review Board (CPP, on 6 November 2018). Participant recruitment began in March 2019. Results will be published in international peer-reviewed medical journals. DISCUSSION: If early administration of inhaled dornase alfa actually reduces the incidence of moderate-to-severe hypoxaemia in patients with severe trauma, this new therapeutic strategy may be easily implemented in many clinical trauma care settings. This treatment may facilitate ventilator weaning, reduce the burden of trauma-induced lung inflammation and facilitate recovery and rehabilitation in severe trauma patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03368092. Registered on 11 December 2017.
has issue date	2020-03-18(xsd:dateTime)
bibo:doi	10.1186/s13063-020-4141-6
bibo:pmid	32183886
has license	cc-by
sha1sum (hex)	0c05d8b73a5d20dba42f4b0235fb7840a72bbad6
schema:url	https://doi.org/10.1186/s13063-020-4141-6
resource representing a document's title	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
has PubMed Central identifier	PMC7079402
has PubMed identifier	32183886
schema:publication	Trials
resource representing a document's body	covid:0c05d8b73a5d20dba42f4b0235fb7840a72bbad6#body_text
is schema:about of	named entity 'MOLECULAR' named entity 'INJURIES' named entity 'BERLIN DEFINITION' named entity 'DAMPs' named entity 'DAMPs' named entity 'NETs' named entity 'cytotoxic effects' named entity 'experimental models' named entity 'damage-associated molecular patterns' named entity 'DNase' named entity 'recombinant' named entity 'dornase alfa' named entity 'hypoxaemia' named entity 'enteral feeding' named entity 'lung' named entity 'Dirichlet prior' named entity 'PEEP' named entity 'flow cytometric' named entity 'randomized clinical trial' named entity 'blood gas analysis' named entity 'HMGB1' named entity 'DSMB' named entity 'logit' named entity 'NETs' named entity 'hypoxaemia' named entity 'Unblinding' named entity 'principal investigator' named entity 'final analysis' named entity 'intensive care unit' named entity 'dornase alfa' named entity 'SOFA score' named entity 'Telemedicine' named entity 'blood urea nitrogen' named entity 'ICU' named entity 'deoxyribonucleases' named entity 'urticaria' named entity 'standard deviation' named entity 'dornase alfa' named entity 'plasma' named entity 'mitochondrial DNA' named entity 'ICU' named entity 'NETs' named entity 'DAMP' named entity 'ICU' named entity 'double-blind' named entity 'transfusion' named entity 'lung' named entity 'poison' named entity 'hypoxaemia' named entity 'ARDS' named entity 'Berlin' named entity 'hypoxaemia' named entity 'distal' named entity 'dornase alfa' named entity 'mechanically ventilated' named entity 'ICU' named entity 'Subgroup analyses' named entity 'primary endpoint' named entity 'creatinine' named entity 'ARDS' named entity 'ARDS' named entity 'central nervous' named entity 'arterial pressure' named entity 'mechanical ventilation' named entity 'placebo' named entity 'hypoxaemia'

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