Study Stopped
COVID pandemic
The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department
1 other identifier
observational
200
1 country
2
Brief Summary
The purpose of this study is to determine if splenomegaly on point-of-care ultrasound (POCUS) is an accurate and user-friendly surrogate to the heterophile antibody test and Epstein-Barr Virus (EBV) serologies to diagnose acute mononucleosis infection in patients presenting with sore throat to the Emergency Department (ED).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2020
CompletedOctober 6, 2020
October 1, 2020
4.5 years
May 31, 2015
October 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of splenomegaly (maximal splenic cranio-caudal length) on point-of-care ultrasound
Splenomegaly is defined as a splenic length of \> 11.5 centimetres (cm) for 10-12 year-old patients, \> 12 cm for 12-15 year-old patients, \> 12 cm for 15-35 year-old female patients, and \> 13 cm for 15-35 year-old male patients.
12 months
Interventions
Enrolled patients will undergo POCUS of the spleen by the treating emergency physician (resident, fellow or attending). Canadian Emergency Ultrasound Society (CEUS) certified residents, fellows and attending physicians will conduct the bedside ultrasonography after receiving specific training for the purposes of this study. The spleen will be assessed using a curved 2-6 Megahertz (MHz) transducer with the participant in the supine position. The cranio-caudal splenic length will be measured and its maximum dimension will be recorded on the standardized study data sheet.
Eligibility Criteria
Convenience sample of patients between July 2016 and October 2017. Inclusion criteria are patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis.
You may qualify if:
- Patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis
You may not qualify if:
- Chronic infectious disorders (eg. tuberculosis, malaria, HIV, syphilis)
- Inflammatory disorders (eg. sarcoidosis, amyloidosis, systemic lupus erythematosus, Felty syndrome)
- Proliferative disorders (eg. lymphoma, leukemia, essential thrombocytopenia, polycythemia vera)
- Congestive disorders (eg: cirrhosis, portal hypertension, right heart failure, congenital heart disease)
- Chronic haemolytic anemia (eg. sickle cell, thalassemia, hereditary spherocytosis)
- Storage diseases (eg. Gaucher, Niemann-Pick)
- Splenectomy
- Inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU Sainte-Justine
Montreal, Quebec, H3T 1C4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Laurie Robichaud, MD
Study Record Dates
First Submitted
May 31, 2015
First Posted
June 4, 2015
Study Start
April 1, 2016
Primary Completion
October 4, 2020
Study Completion
October 4, 2020
Last Updated
October 6, 2020
Record last verified: 2020-10