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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02463669
Other study ID # POCUSIM01
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 2016
Est. completion date October 4, 2020

Study information

Verified date October 2020
Source Jewish General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Description:

The investigators seek to determine whether the presence of splenomegaly on POCUS can accurately diagnose acute infectious mononucleosis in symptomatic ED patients, and determine the feasibility of performing point-of-care ultrasound for splenomegaly by emergency physicians in the emergency department setting.


Recruitment information / eligibility

Status Terminated
Enrollment 200
Est. completion date October 4, 2020
Est. primary completion date October 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 35 Years
Eligibility Inclusion Criteria:

- Patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis

Exclusion Criteria:

- 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

Study Design


Intervention

Device:
Point-of-care ultrasound
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.

Locations

Country Name City State
Canada CHU Sainte-Justine Montreal Quebec
Canada Jewish General Hospital Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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