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Chemical InjuryCBRNEObsNCT05026645

The Medical Management in Patients Exposed to Weapons of Mass Destruction

An observational study of Chemical Injury and Chemicals; Intoxication, run by St. Justine's Hospital at 15 sites in 6 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Observation study measuring medical response in contaminated environment. Read more about this study

Who is it for?
Any age
What is being tested?
Clinical interventions performed in acute settings (contaminated environment), Protection (clinician and patient) and Decontamination (clinician and patient)
Type of treatment
Surgery or procedure
How many people
1,000 participants
Where
15 sitesin 6 countries
Study dates
1 Oct 2020to 1 Dec 2036
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.

Who may be able to join

  • 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;
  • Patients are eligible if they were exposed to the CBRNE attack;
  • 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);
  • Participants must be able to complete the online case report form in English; and
  • The approval of an Ethics Review Board is obtained by each medical centre participant.

Who cannot join

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

Trial locations and contacts

15 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

15 sites in 6 countries

Canada7 sites
  • École de Technologie Supérieure Université du Québec

    Montreal, Quebec, H3C 1K3

  • Research Center of the CHU St-Justine, University of Montreal

    Montreal, Quebec, H3T 1C5

  • Royal Canadian Medical Corps

    Ottawa, Ontario, K1A0K2

  • Research Centre, Quebec Heart and Lung Institute, Laval University

    Québec, Quebec, G1V 4G5

  • Medical Intelligence CBRNE Inc.

    Québec, Quebec, G1V0C8

  • Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network

    Sherbrooke, Quebec, J1K 2R1

  • Centre for Defence and Security Studies, University of Manitoba

    Winnipeg, Manitoba, R3T 2N2

Other trials in Canada

Japan3 sites
  • Tokyo Women's Medical University, Department of Intensive Care Medicine

    Tokyo, Shinjuku-ku

  • Department of Critical care, Miyagi Children's Hospital

    Tokyo

  • Department of Disaster Medical Management, The University of Tokyo Hospital

    Tokyo

Other trials in Japan

United Kingdom2 sites
  • Surrey and Sussex Healthcare NHS Trust

    Surrey Quays, Redhill, RH1 5RH

  • CBRNE World Journal

    Winchester, SO23 8UT

Other trials in United Kingdom

United States1 site
  • Director, Unconventional Weapons & Technology Division, National Consortium for the Study of Terrorism and Responses to Terrorism University of Maryland

    College Park, Maryland, 20740

Other trials in United States

Czechia1 site
  • University of Finance and Administration Department of Criminology and Forensic Disciplines

    Prague, Prague, 10100

Other trials in Czechia

France1 site
  • Sorbonne University

    Paris, Île-de-France Region

Other trials in France

About this study

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

Observation study measuring medical response in contaminated environment.

Read the 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.

Being tested
Clinical interventions performed in acute settings (contaminated environment), Protection (clinician and patient), Decontamination (clinician and patient)
Keywords
CBRNE Defence, Acute Settings, Pre-Hospital Settings, Decontamination, Protection, Respiratory Insults, Treatments
Medical subject headings
Respiratory Distress Syndrome, Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical interventions performed in acute settings (contaminated environment)Procedure or surgery

    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 or surgery

    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 or surgery

    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.

Study groups in NCT05026645
Study groupRoleWhat they receive
adult inflicted by a CBRNE weaponPart of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient)
Infant inflicted by a CBRNE weaponPart of the population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient)
Women inflicted by a CBRNE weaponPart of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient)
Men inflicted by a CBRNE weaponPart of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient)
Elderly inflicted by a CBRNE weaponPart of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient)
Diagnosed with chronic disease(s) inflicted by a CBRNE weaponPart of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient)
Clinician (adult) whom performs his/her clinical interventionsClinician (adult) whom performs his/her clinical interventions while integrating competences in protections and decontamination. Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. This is the case of when the clinician is required to ensure safety toward his/her patient while performing his/her interventions \& procedures.
Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient)
Clinician (adult) injured by duties circumstancesPart of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. This is the case of when the clinician becomes inflicted by a CBRNE weapon while intervening toward contaminated patient due to any failure in protection and decontamination.
Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intervention and location

    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)

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

Secondary outcomes (4)
  1. Contamination is under-control due to efficient protective measures applied during a medical extraction/evacuation

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

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

  2. Contamination under-control due to efficient decontamination measures applied during a medical extraction/evacuation

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

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

  3. Deterioration of the patient's health condition due to compromised means of protection

    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).

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

  4. Deterioration of the patient's health condition due to compromised means of decontamination

    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)).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2021
  2. Study start1 Oct 2020
  3. Primary completion1 Nov 2036 (estimated)
  4. Study completion1 Dec 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05026645
Sponsor's protocol ID
2020-2561
Acronym
CBRNEObs
Status last verified
Sep 2025
First submitted
18 Aug 2021
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: At this stage, we do have any plan. However, for the interest of pursuing the research, that matter will require to be addressed in due time.

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.

    PubMed 36175098

Questions about this trial

What is this clinical trial studying?

An observational study of Chemical Injury and Chemicals; Intoxication, run by St. Justine's Hospital at 15 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Canada, Japan, United Kingdom, United States, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention and location (time frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05026645, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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