Menu
Enrolling by invitation NCT05026645

The Medical Management in Patients Exposed to Weapons of Mass Destruction

— Observational Chemical Injury Chemicals; Intoxication Acute Respiratory Distress Syndrome Distress Respiratory Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinical interventions performed in acute settings (contaminated environment), Protection (clinician and patient), Decontamination (clinician and patient).
Who it may be relevant to
Registry conditions: Chemical Injury, Chemicals; Intoxication, Acute Respiratory Distress Syndrome, Distress Respiratory Syndrome. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, Czechia, France, Japan +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Acute Care For Patients Exposed to a Chemical, Biological, Radiological, Nuclear, Explosive: Attack: Protocol For An International Multicentric Observational Study

Overview

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.

Interventions

  • Procedure Clinical interventions performed in acute settings (contaminated environment)
    Any clinical intervention performed on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic).
  • Procedure Protection (clinician and patient)
    As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with.
  • Procedure Decontamination (clinician and patient)
    As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in c

Primary outcome measures

  • Intervention and location [Time frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).]
Secondary outcome measures (4)
  • Contamination is under-control due to efficient protective measures applied during a medical extraction/evacuation [Time frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).]
  • Contamination under-control due to efficient decontamination measures applied during a medical extraction/evacuation [Time frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).]
  • Deterioration of the patient's health condition due to compromised means of protection [Time frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).]
  • Deterioration of the patient's health condition due to compromised means of decontamination [Time frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Canada · 7 centers
  • Centre for Defence and Security Studies, University of Manitoba — Winnipeg
  • Royal Canadian Medical Corps — Ottawa
  • École de Technologie Supérieure Université du Québec — Montreal
  • Research Center of the CHU St-Justine, University of Montreal — Montreal
  • Research Centre, Quebec Heart and Lung Institute, Laval University — Québec
  • Medical Intelligence CBRNE Inc. — Québec
  • Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Networ — Sherbrooke
Japan · 3 centers
  • Tokyo Women's Medical University, Department of Intensive Care Medicine — Tokyo
  • Department of Critical care, Miyagi Children's Hospital — Tokyo
  • Department of Disaster Medical Management, The University of Tokyo Hospital — Tokyo
United Kingdom · 2 centers
  • Surrey and Sussex Healthcare NHS Trust — Surrey Quays
  • CBRNE World Journal — Winchester
United States · 1 center
  • Director, Unconventional Weapons & Technology Division, National Consortium for the Study — College Park
Czechia · 1 center
  • University of Finance and Administration Department of Criminology and Forensic Discipline — Prague
France · 1 center
  • Sorbonne University — Paris

Publications

  • 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. PMID 36175098

Identifiers

NCT: NCT05026645 · 2020-2561

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗