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Canadian Anaphylaxis Network- Predicting Recurrence After Emergency Presentation for Allergic REaction

Study Purpose

BACKGROUND: Anaphylaxis is the most severe form of allergy that rapidly affects multiple body systems and can be deadly. The highest incidence of anaphylaxis is in children and adolescents. In Canada, approximately every 10 minutes there is an Emergency Department (ED) visit for food allergy, and up to 80% of anaphylactic reactions in children are triggered by food. The ambiguity in how physicians manage anaphylaxis adds a huge burden to health care and further contributes to ED crowding. Current Canadian and international treatment guidelines universally recommend that all patients present to the ED for a prolonged period (6-24 hours) of in-hospital monitoring after initial reactions have been treated, to increase detection of biphasic anaphylaxis (BA). BA is a second wave of symptoms after initial resolution. These guidelines are based on poor or little evidence and have unintended negative impacts on patient safety and quality of life. Furthermore, this 'one-size fits all' approach to care leads to wasteful resource utilization that provides low value care. OBJECTIVE: The main objective of the study is to derive a clinical prediction rule that identifies children with anaphylaxis who are at risk of BA. METHODS: This prospective multicenter cohort study will enroll 1682 patients from 7 pediatric EDs that are members of the Pediatric Emergency Research Canada (PERC) network. We will enroll patients < 18 years of age presenting to the ED with an allergic reaction that matches the diagnostic criteria of anaphylaxis. Research assistants (RA) present in the ED will screen, obtain consent, and prospectively collect all study data. The Research Assistant or Research Nurse will follow patients during their ED visit and ascertain, in conjunction with the medical team, if the patient developed biphasic anaphylaxis in the ED. A standardized follow-up survey conducted within 2-5 days of ED or hospital discharge will determine if a biphasic reaction occurred following ED disposition. We established an advisory council comprised of end-users and community partners external to the project team to monitor project milestones. STUDY TEAM: We have established an international multidisciplinary team of experts in pediatrics, emergency medicine, allergy/immunology, research methodology and statistics, and knowledge translation. Our team is supported by the PERC network. EXPECTED OUTCOME: Providing the best evidence-based, value care at the lowest cost is a moral and ethical imperative. Therefore, in alignment with national and international research priorities, we propose to develop a robust prediction model for BA. This model will address a significant gap in current knowledge and practice, with anticipated benefit for patient care and health system efficiency worldwide. This trial will generate novel, clinically relevant data on optimal ED management of children with anaphylaxis that integrates best value care with patient safety.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients < 18 years of age presenting to the ED with an allergic reaction that matches diagnostic criteria for anaphylaxis as defined by the World Allergy Organization (WAO) in 2019.
The 2019 WAO anaphylaxis guidelines clarify the involvement of two organ systems to diagnose anaphylaxis, stating that "although the diagnosis of anaphylaxis usually depends on the involvement of multiple organ systems, anaphylaxis may present as an acute cardiac or respiratory event as the only manifestation of anaphylaxis." Thus, a patient with isolated hypotension, bronchospasm, or upper airway obstruction after exposure to a known or potential trigger will be deemed to have anaphylaxis, even if typical skin features are absent.
  • - Language proficiency in English or French.

Exclusion Criteria:

  • - Anaphylactic reaction that occurred in the context of a suicidal attempt or intoxication.
  • - Anaphylactic reaction that begins in hospital and managed outside ED (on an inpatient or outpatient unit) - Patient who is unable to complete the follow-up survey post ED discharge.
- Previous enrollment in the CAN-PREPARE Study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05135377
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Waleed Alqurashi
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Waleed Alqurashi, MDAmy C Plint, MDMarcus S Shaker, MD
Principal Investigator Affiliation Children's Hospital of Eastern OntarioChildren's Hospital of Eastern OntarioDartmouth-Hitchcock Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Anaphylaxis
Arms & Interventions

Arms

: Children with Anaphylaxis

Patients under 18 years of age presenting to the Emergency Department (ED) with an allergic reaction that matches diagnostic criteria for anaphylaxis.

Interventions

Other: - Observational

Not applicable - observational study

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Alberta Children's Hospital, Calgary, Alberta, Canada

Status

Not yet recruiting

Address

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8

Site Contact

Jena Shank, MSc

Jena.Shank@albertahealthservices.ca

613-737-8899

Stollery Children's Hospital, Edmonton, Alberta, Canada

Status

Not yet recruiting

Address

Stollery Children's Hospital

Edmonton, Alberta, T6G 2C8

Site Contact

Nadia Shular, RN

nadiashular@ualberta.ca

613-737-8899

McMaster University, Hamilton, Ontario, Canada

Status

Not yet recruiting

Address

McMaster University

Hamilton, Ontario, L8S 4L8

Site Contact

Redjana Carciumaru, MD, MSc

carciur@mcmaster.ca

613-737-8899

Children's Hospital of Western Ontario, London, Ontario, Canada

Status

Not yet recruiting

Address

Children's Hospital of Western Ontario

London, Ontario, N6A 5W6

Site Contact

Kamary Coriolano DaSilva, PhD

Kamary.CoriolanoDaSilva@lhsc.on.ca

613-737-8899

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

Status

Recruiting

Address

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1

Site Contact

Cheryl Kreviazuk

ckreviazuk@cheo.on.ca

613-737-8899

The Hospital for Sick Children, Toronto, Ontario, Canada

Status

Not yet recruiting

Address

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8

Site Contact

Judy Sweeney, RN, BScN

judy.sweeney@sickkids.ca

613-737-8899

Montreal, Quebec, Canada

Status

Not yet recruiting

Address

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5

Site Contact

Frédérique Drapeau-Jacob

frederique.drapeau-jacob.hsj@ssss.gouv.qc.ca

613-737-8899

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