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Enrolling by Invitation

NCT Number: NCT05026645

The Medical Management in Patients Exposed to Weapons of Mass Destruction

Observation study measuring medical response in contaminated environment.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Defence and Security Studies, University of Manitoba, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical interventions performed in acute settings (contaminated environment)

Procedure

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).

Protection (clinician and patient)

Procedure

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.

Decontamination (clinician and patient)

Procedure

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 closed/contact with. This crucial step is usually expected prior the patient's transfer into a clean zone like the emergency room or its equivalent.

Primary outcomes

  1. Intervention and location

    Time frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).

    The percentage of patients to whom the World Health Organization's healthcare guidelines were applied without any delay (i.e.: during a medical extraction/evacuation)

Secondary outcomes

  1. 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).

    The percentage of patients whose health condition remained stable during a medical extraction due to efficient WHO's protective measures applied

  2. 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).

    The percentage of patients whose health condition remained stable during a medical extraction due to efficient WHO's decontamination measures applied

  3. 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).

    The percentage of patients whose health condition deteriorate during a medical extraction due to the misuse of WHO's protective measures (e.g.: mask, suit, gloves, boots, etc).

  4. 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).

    The percentage of patients whose health condition deteriorated during a medical extraction due to the misuse of WHO's decontamination measures (e.g.: immediate (roughly) or/and thorough (specialized one)).

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Collaborators

  • Biomedical Telematics Laboratory, Quebec Respiratory Health Research Network, Sherbrooke, Canada
  • Centre for Defence and Security Studies, University of Manitoba, Winnipeg, Canada
  • Department of Intensive Care Medicine, Tokyo, Japan
  • Medical Intelligence CBRNE inc.; Quebec City, Canada
  • Quebec Heart and Lung Institute, Quebec City, Canada
  • Sorbonne University
  • Tokyo University
  • Tokyo Women's Medical University
  • University of Maryland, College Park

Registry information

Official study title

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

Acronym: CBRNEObs

Important dates

Study start
2020
Primary completion
2036
Study completion
2036
First posted
Aug 30, 2021
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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