Copperhead Envenomation Observational Study

Observational Study of Recovery From Copperhead Snake Envenomation

The primary objective of the study is to evaluate the responsiveness and utility of several clinical outcome assessments in the setting of copperhead snakebite. The secondary objective is to characterize the clinical course of signs, symptoms and impairment during the recovery phase of copperhead snakebite.

Study Overview

• Status: Completed
• Conditions: Copperhead Snake Envenomation

Detailed Description

This observational study will document the patient's recovery from copperhead snakebite. All care provided will be at the discretion of the treating physician in accordance with the local standard of care.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • LSU Health Sciences Center
  • Michigan
    • Jackson, Michigan, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • St. Louis, Missouri, United States, 76104
      • Washington University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Medical Center
    • Greenville, North Carolina, United States, 27834
      • Vidant Health
  • Texas
    • Bryan, Texas, United States, 77802
      • St. Joseph Regional Health Center
    • Ft. Worth, Texas, United States, 76104
      • Harris Methodist Hospital
    • Temple, Texas, United States, 76508
      • Scott and White Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia, Blue Ridge PC
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University Richmond

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Males and non-pregnant females at least 18 yrs of age with evidence of copperhead envenomation on an extremity distal to the knee or elbow that present for care at a health care facility within 24 hours of envenomation.

Description

Inclusion Criteria:

• Envenomation by a copperhead snake
• Presentation for care at a health care facility within 24 hrs of envenomation
• Envenomation on an extremity distal to the knee or elbow
• Clinical evidence of venom effect (limb swelling and/or tenderness)
• Enrollment can be completed within 48 hrs of envenomation prior to discharge
• Patient is willing and able to complete follow-up schedule of assessments
• Patient is able to read, comprehend and sign IRB approved informed consent
• Patient is able to read and comprehend written assessment tools
• Patient is at least 18 yrs old
• Patient is sober, competent and able to complete verbal and written informed consent

Exclusion Criteria:

• Patient is pregnant or breastfeeding
• Patient is a prisoner
• Patient has distracting injury, condition with acute pain or functional impairment, and/or is unable to make a reliable self-report of status
• Patient has had previous snake envenomation to any body area within 30 days prior to screening/enrollment, regardless of whether antivenom was administered
• Patient had an acute traumatic or medical event, surgery, or exacerbation of pre-existing medical or surgical condition effecting the envenomated extremity within 30 days prior to screening/enrollment
• Patient has participated in a clinical study involving and investigational pharmaceutical product or device within 3 months prior to screening that may have impact on clinical outcomes of snakebite
• Patient has previously participated in this study
• Patient is, in the investigator's opinion, otherwise unsuitable for participation. Note: Treatment with antivenom prior to eligibility evaluation is not an exclusion criterion

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient Global Assessment of Recovery (PGAR)	Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Numeric Pain Rating Scale (NPRS)	Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Numeric Swelling Score (NSS)	Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
SF36v2 (Acute Version)	Time of Discharge, Day 7, Day, 14, Day 21, and Day 28
Swelling Figure-of-8 Measurement	Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Grip Strength	Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Walking Speed	Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Patient Global Impression of Change (PGIC)	Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Return to Work/School/ADLs	Day 3, Day 7, Day 14, Day 21, and Day 28
Patient-Specific Functional Scale (PSFS)	Day 3, Day 7, Day 14, Day 21, and Day 28
WPAI:SHP V2	Day 3, Day 7, Day 14, Day 21, and Day 28
Disorders of the Arm, Shoulder, and Hand (DASH)	Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Lower Extremity Functional Scale	Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28

Collaborators and Investigators

• Sponsor: BTG International Inc.

Publications and helpful links

General Publications

• Lavonas EJ, Gerardo CJ; Copperhead Snakebite Recovery Outcome Group. Prospective study of recovery from copperhead snake envenomation: an observational study. BMC Emerg Med. 2015 May 15;15:9. doi: 10.1186/s12873-015-0033-6.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): April 1, 2013

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): May 13, 2013
• Last Update Submitted That Met QC Criteria: May 10, 2013
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: copperhead snake envenomation
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Wounds and Injuries; Bites and Stings; Poisoning; Snake Bites
• Other Study ID Numbers: BTG-PR005-001