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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05026645
Other study ID # 2020-2561
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date December 1, 2036

Study information

Verified date November 2023
Source St. Justine's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Observation study measuring medical response in contaminated environment.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date December 1, 2036
Est. primary completion date November 1, 2036
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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).
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.
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 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.

Locations

Country Name City State
Canada Research Center of the CHU St-Justine, University of Montreal Montreal Quebec
Canada Royal Canadian Medical Corps Ottawa Ontario
Canada Medical Intelligence CBRNE Inc. Quebec
Canada Research Centre, Quebec Heart and Lung Institute, Laval University Quebec
Canada Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network Sherbrooke Quebec
Canada Centre for Defence and Security Studies, University of Manitoba Winnipeg Manitoba
Canada School of Nursing, Manitoba University Winnipeg Manitoba
France Sorbonne University Paris Ile De France
Japan Department of Critical care, Miyagi Children's Hospital Tokyo
Japan Department of Disaster Medical Management, The University of Tokyo Hospital Tokyo
Japan Tokyo Women's Medical University, Department of Intensive Care Medicine Tokyo Shinjuku-ku
United States Director, Unconventional Weapons & Technology Division, National Consortium for the Study of Terrorism and Responses to Terrorism University of Maryland College Park Maryland

Sponsors (10)

Lead Sponsor Collaborator
St. Justine's Hospital 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

Countries where clinical trial is conducted

United States,  Canada,  France,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Secondary 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 At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Secondary 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 At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Secondary 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). At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Secondary 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)). At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
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