AnaphylaxisCAN-PREPARENCT05135377
Canadian Anaphylaxis Network- Predicting Recurrence After Emergency Presentation for Allergic REaction
An observational study of Anaphylaxis, run by Waleed Alqurashi at 7 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Anaphylaxis
- What is being tested?
- Observational
- How many people
- 1,682 participants
- Where
- 7 sitesCanada
- Study dates
- 11 Apr 2022to 31 Dec 2025
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients under the age of 18 who present to the Emergency Department with an allergic reaction that matches diagnostic criteria for anaphylaxis.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta, T6G 2C8
McMaster University
Hamilton, Ontario, L8S 4L8
Children's Hospital of Western Ontario
London, Ontario, N6A 5W6
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
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.
Read more
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.
- Conditions
- Anaphylaxis
- Being tested
- Observational
- Keywords
- Biphasic Anaphylaxis
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Not applicable - observational study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 days post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start11 Apr 2022
- Primary completion16 Apr 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnaphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waleed Alqurashi
- Sponsor type
- University, hospital or other
- Collaborators
- Stollery Children's Hospital, Children's Hospital of Western Ontario, The Hospital for Sick Children, Alberta Children's Hospital, McMaster University, CHU Ste-Justine, Montreal, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Waleed Alqurashi, Children's Hospital of Eastern Ontario
- Investigators
- Waleed Alqurashi, MD, Principal investigator, Children's Hospital of Eastern OntarioAmy C Plint, MD, Principal investigator, Children's Hospital of Eastern OntarioMarcus S Shaker, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135377
- Sponsor's protocol ID
- CTO 3721
- Acronym
- CAN-PREPARE
- Status last verified
- Apr 2025
- First submitted
- 11 Nov 2021
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alqurashi W, Shaker M, Wells GA, Collins GS, Greenhawt M, Curran JA, Zemek R, Schuh S, Ellis A, Gerdts J, Kreviazuk C, Dixon A, Eltorki M, Freedman SB, Gravel J, Poonai N, Worm M, Plint AC. Canadian Anaphylaxis Network-Predicting Recurrence after Emergency Presentation for Allergic REaction (CAN-PREPARE): a prospective, cohort study protocol. BMJ Open. 2022 Oct 31;12(10):e061976. doi: 10.1136/bmjopen-2022-061976.
PubMed 36316072
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Anaphylaxis Network- Predicting Recurrence After Emergency Presentation for Allergic REaction
- ClinicalTrials.gov ID
- NCT05135377
- Acronym / sponsor ID
- CAN-PREPARE / CTO 3721
- Conditions
- Anaphylaxis
- Keywords
- Biphasic Anaphylaxis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,682 participants (actual)
- Lead sponsor
- Waleed AlqurashiUniversity, hospital or other
- Collaborators
- Stollery Children's Hospital, Children's Hospital of Western Ontario, The Hospital for Sick Children, Alberta Children's Hospital, McMaster University, CHU Ste-Justine, Montreal, Canadian Institutes of Health Research (CIHR)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Anaphylaxis | – | Other: ObservationalPatients under 18 years of age presenting to the Emergency Department (ED) with an allergic reaction that matches diagnostic criteria for anaphylaxis. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients under the age of 18 who present to the Emergency Department with an allergic reaction that matches diagnostic criteria for anaphylaxis.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalNot applicable - observational study | Other | Children with Anaphylaxis |
Primary outcome
Incidence of biphasic anaphylaxis
Time frame: Up to 5 days post enrollment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Background: PubMed 36316072Alqurashi W, Shaker M, Wells GA, Collins GS, Greenhawt M, Curran JA, Zemek R, Schuh S, Ellis A, Gerdts J, Kreviazuk C, Dixon A, Eltorki M, Freedman SB, Gravel J, Poonai N, Worm M, Plint AC. Canadian Anaphylaxis Network-Predicting Recurrence after Emergency Presentation for Allergic REaction (CAN-PREPARE): a prospective, cohort study protocol. BMJ Open. 2022 Oct 31;12(10):e061976. doi: 10.1136/bmjopen-2022-061976.
- Study Protocol PublicationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed Alqurashi, MD principal investigator
Children's Hospital of Eastern Ontario
Amy C Plint, MD principal investigator
Children's Hospital of Eastern Ontario
Marcus S Shaker, MD principal investigator
Dartmouth-Hitchcock Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaphylaxis, run by Waleed Alqurashi at 7 sites in Canada.
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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. 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?
Incidence of biphasic anaphylaxis (time frame: Up to 5 days post enrollment). 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 NCT05135377, 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 22 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.