Clinical trial NCT05026645: The Medical Management in Patients Exposed to Weapons of Mass Destruction
Official title: Acute Care for Patients Exposed to a Chemical, Biological, Radiological, Nuclear, Explosive: Attack: Protocol for an International Multicentric Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chemical Injury
Chemicals; Intoxication
Acute Respiratory Distress Syndrome
Distress Respiratory Syndrome
Medical Emergencies
Keywords: CBRNE Defence
Acute Settings
Pre-Hospital Settings
Decontamination
Protection
Respiratory Insults
Treatments
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Quebec Heart and Lung Institute, Quebec City, Canada
name: Sorbonne University
name: Medical Intelligence CBRNE inc.; Quebec City, Canada
name: Department of Intensive Care Medicine, Tokyo, Japan
name: Centre for Defence and Security Studies, University of Manitoba, Winnipeg, Canada
name: Biomedical Telematics Laboratory, Quebec Respiratory Health Research Network, Sherbrooke, Canada
name: Tokyo University
name: Tokyo Women's Medical University
name: University of Maryland, College Park
First posted: 2021-08-30
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.

Brief summary: Observation study measuring medical response in contaminated environment.

Detailed description: This is an ongoing multicentric observational study that aims to assess the medical response to chemical, biological, radiological, nuclear, explosive (cbrne) events during the last five (5) decades (i.e.: 1970-2020), and in any future cbrne attack that might occur within the next 15 years (i.e.: 2021-2036). Of note, the data collection will be performed retrospectively and after sites review ethic board (REB) approval.

Eligibility criteria: Inclusion Criteria:

i. a CBRNE attack caused at least one casualty who required the assistance of the participating health care system (e.g.: physicians, nurses, paramedics and other health-care specialists of a medical facility) during a medical extraction from the incident site until admission to a medical facility;

ii. Patients are eligible if they were exposed to the CBRNE attack;

iii. Medical information concerning the CBRNE exposures, even if partial, is accessible to health care professionals for the purposes of filling out the online case report form (eCRF);

iv. Participants must be able to complete the online case report form in English; and

v. The approval of an Ethics Review Board is obtained by each medical centre participant.

Exclusion Criteria:

A negative response to any of the inclusion criteria results in an exclusion.

Primary outcomes:
measure: Intervention and location
timeFrame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Secondary outcomes:
measure: Contamination is under-control due to efficient protective measures applied during a medical extraction/evacuation
timeFrame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
measure: Contamination under-control due to efficient decontamination measures applied during a medical extraction/evacuation
timeFrame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
measure: Deterioration of the patient's health condition due to compromised means of protection
timeFrame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
measure: Deterioration of the patient's health condition due to compromised means of decontamination
timeFrame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Other outcomes:
Locations:
city: College Park
country: United States
facility: Director, Unconventional Weapons & Technology Division, National Consortium for the Study of Terrorism and Responses to Terrorism University of Maryland
state: Maryland
city: Winnipeg
country: Canada
facility: Centre for Defence and Security Studies, University of Manitoba
state: Manitoba
city: Winnipeg
country: Canada
facility: School of Nursing, Manitoba University
state: Manitoba
city: Ottawa
country: Canada
facility: Royal Canadian Medical Corps
state: Ontario
city: Montreal
country: Canada
facility: Research Center of the CHU St-Justine, University of Montreal
state: Quebec
city: Sherbrooke
country: Canada
facility: Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network
state: Quebec
city: Quebec
country: Canada
facility: Research Centre, Quebec Heart and Lung Institute, Laval University
city: Quebec
country: Canada
facility: Medical Intelligence CBRNE Inc.
city: Paris
country: France
facility: Sorbonne University
state: ile de France
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University, Department of Intensive Care Medicine
state: Shinjuku-ku
city: Tokyo
country: Japan
facility: Department of Critical care, Miyagi Children's Hospital
city: Tokyo
country: Japan
facility: Department of Disaster Medical Management, The University of Tokyo Hospital
Study officials:
affiliation: Ste-Justine's Hospital
name: Stephane Bourassa
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bourassa S, Noebert D, Dauphin M, Rambaud J, Kawaguchi A, Leger F, Beijer D, Fortier Y, Dligui M, Ivanovski H, Simard S, Jouvet P, Leclerc J. Acute care for patients exposed to a chemical attack: protocol for an international multicentric observational study. BMJ Open. 2022 Sep 29;12(9):e065015. doi: 10.1136/bmjopen-2022-065015.