The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis (APPY1)

The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis in Children, Adolescents, and Young Adults Presenting to the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Acute Appendicitis

• Study Type: Observational
• Enrollment (Actual): 2201

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hosptial
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • Sacramento, California, United States, 95817
      • UC Davis
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida, College of Medicine
    • St. Petersburg, Florida, United States, 33701
      • All Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory-Egleston (CHOA)
    • Atlanta, Georgia, United States, 30342
      • Scottish Rite (CHOA)
  • Massachusetts
    • Newton, Massachusetts, United States, 02462
      • Newton-Wellesley Hospital
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
    • Weymouth, Massachusetts, United States, 02190
      • South Shore Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan, Mott Children's Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health System
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • The Children's Mercy Hosptial
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth Hitchcock Medical Center
  • New York
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27175
      • Wake Forest Baptist Health
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital
    • Cleveland, Ohio, United States, 44495
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU
  • Pennsylvania
    • Pittsburg, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburg
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital - Hasbro
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Children's Hospital
  • Texas
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center
    • Bryan, Texas, United States, 77802
      • St. Joseph's Regional Health Center
    • College Station, Texas, United States, 77845
      • St. Joseph's Emergency Center
    • Dallas, Texas, United States, 75235
      • Dallas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children, adolescents and young adults 2 to 20 years old.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity, Specificity, Negative and Positive Predictive Value	95% confidence intervals on Sensitivity and Specificity	Upon 3rd party review of data

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT utilization	CT utilization behaviors based on questions posed to the physicians about their current imaging intentions and those intentions were an APPY1 Test result available	Upon 3rd party review of data

Collaborators and Investigators

• Sponsor: Venaxis, Inc.
• Investigators: Principal Investigator: Dave Huckins, MD, Newton-Wellesley Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: July 25, 2012
• First Submitted That Met QC Criteria: July 26, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Estimate): March 24, 2014
• Last Update Submitted That Met QC Criteria: March 20, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Acute Disease; Appendicitis
• Other Study ID Numbers: CP12-001