The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis
- Conditions
- Acute Appendicitis
- Registration Number
- NCT01652170
- Lead Sponsor
- Venaxis, Inc.
- Brief Summary
This study will consist of a brief interaction with the subject or parent or guardian to obtain consent, collect a blood sample, medical history, and physical examination of those who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well as processed into plasma in order to compute the APPY1 Test result, which is based on a combination of the WBC value and the plasma MRP 8/14 and CRP concentrations received from the APPY1 Test cassette. There will be a 2-week (14 days +/- 3) follow-up telephone call for those subjects that were discharged from the ED without an appendectomy or diagnosis of acute appendicitis. Use of the APPY1 Test to help identify low risk patients could significantly reduce the use of CT scans in diagnosis of AA, thereby reducing the exposure to ionizing radiation in children, adolescents, and young adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2201
- 2 to 20 years old (up until the 21st birthday),
- Right lower quadrant or poorly localized abdominal pain, or tenderness that includes the right lower quadrant, and/or other features including, but not limited to, nausea, vomiting, and/or anorexia, requiring acute appendicitis to be added to the differential,
- Onset of abdominal pain within 72 hours or less,
- Patients of either gender may participate and,
- Patient or accompanying parent or guardian is able to provide informed consent.
- History includes prior appendectomy,
- Subjects whose presentation history and physical examination place them at such high risk of acute appendicitis that it would be clinically reasonable to proceed with exploratory laparotomy and/or appendectomy without advanced imaging,
- Treatment with any immunosuppressive medication or chemotherapeutic agents within 28 days, or systemic steroids (oral or intravenous) within 14 days,
- History of end-stage, metastatic cancer or an active immune disorder,
- History includes abdominal trauma or invasive abdominal procedures/surgery within the previous two weeks,
- Patients who have received diagnostic imaging (CT, MRI, or US) for abdominal pain in the previous two weeks,
- Patients with report of abdominal pain greater than 72 hours,
- History of active bleeding disorder, which may complicate phlebotomy or placement of peripheral IV catheter,
- Participation in a research study within the previous 30 days,
- Prisoners of an adult or juvenile detention center, and
- Subject, parent or guardian unable to provide informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity, Specificity, Negative and Positive Predictive Value Upon 3rd party review of data 95% confidence intervals on Sensitivity and Specificity
- Secondary Outcome Measures
Name Time Method CT utilization Upon 3rd party review of data CT utilization behaviors based on questions posed to the physicians about their current imaging intentions and those intentions were an APPY1 Test result available
Trial Locations
- Locations (29)
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Spectrum Health System
🇺🇸Grand Rapids, Michigan, United States
UC Davis
🇺🇸Sacramento, California, United States
Phoenix Children's Hosptial
🇺🇸Phoenix, Arizona, United States
Scottish Rite (CHOA)
🇺🇸Atlanta, Georgia, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Emory-Egleston (CHOA)
🇺🇸Atlanta, Georgia, United States
University of Florida, College of Medicine
🇺🇸Jacksonville, Florida, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Newton-Wellesley Hospital
🇺🇸Newton, Massachusetts, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
South Shore Hospital
🇺🇸Weymouth, Massachusetts, United States
University of Michigan, Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
The Children's Mercy Hosptial
🇺🇸Kansas City, Missouri, United States
OHSU
🇺🇸Portland, Oregon, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Nationwide Children's
🇺🇸Columbus, Ohio, United States
Rhode Island Hospital - Hasbro
🇺🇸Providence, Rhode Island, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Children's Hospital of Pittsburg
🇺🇸Pittsburg, Pennsylvania, United States
St. Joseph's Regional Health Center
🇺🇸Bryan, Texas, United States
St. Joseph's Emergency Center
🇺🇸College Station, Texas, United States
Dallas Children's Hospital
🇺🇸Dallas, Texas, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Vanderbilt Children's Hospital
🇺🇸Nashville, Tennessee, United States
Dell Children's Medical Center
🇺🇸Austin, Texas, United States