An observational study in Anaphylaxis, sponsored by Waleed Alqurashi. Active, not recruiting at 7 sites in Canada. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-04-22.
Sponsored by Waleed Alqurashi · Observational
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.
100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.
This study's enrollment of 1,682 is above the median of 137 across 48 observational studies indexed under Anaphylaxis.
Browse Anaphylaxis studies →This is the only study on the registry with Waleed Alqurashi as lead sponsor.
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All patients under the age of 18 who present to the Emergency Department with an allergic reaction that matches diagnostic criteria for anaphylaxis.
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Exclusion Criteria:
Patients under 18 years of age presenting to the Emergency Department (ED) with an allergic reaction that matches diagnostic criteria for anaphylaxis.
Other: Observational
Not applicable - observational study
Incidence of biphasic anaphylaxis
The primary outcome for this prospective cohort study of children who present to ED with anaphylaxis is the development of biphasic anaphylaxis (BA) in the ED or after hospital/ED discharge. As per the published consensus definition in 2019, to be classified as BA, an anaphylactic reaction must meet 3 criteria: 1) initial anaphylactic reaction followed by resolution of all initial manifestations for ≥1 h, with no new symptoms or treatment administered in that time; 2) the second phase of new or recurrent symptoms or signs that meet the consensus definition of anaphylaxis, and 3) the new or recurrent symptoms or signs are not caused by antigen re-exposure. This definition focuses on clinically important or major biphasic reactions. Mild symptoms that involve only the skin (e.g. urticarial rash) without any other systems involvement will be captured and classified as minor biphasic responses. However, these minor responses do not meet our case definition for BA.
Time frame: Up to 5 days post enrollment
Plan to share: Undecided
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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