Copperhead Envenomation Observational Study
- Conditions
- Copperhead Snake Envenomation
- Registration Number
- NCT01651299
- Lead Sponsor
- BTG International Inc.
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Return to Work/School/ADLs Day 3, Day 7, Day 14, Day 21, and Day 28 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Duke Medical Center
🇺🇸Durham, North Carolina, United States
Washington University
🇺🇸St. Louis, Missouri, United States
Vidant Health
🇺🇸Greenville, North Carolina, United States
University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
University of Virginia, Blue Ridge PC
🇺🇸Charlottesville, Virginia, United States
Virginia Commonwealth University Richmond
🇺🇸Richmond, Virginia, United States
University of Mississippi Medical Center
🇺🇸Jackson, Michigan, United States
St. Joseph Regional Health Center
🇺🇸Bryan, Texas, United States
Scott and White Hospital
🇺🇸Temple, Texas, United States
Harris Methodist Hospital
🇺🇸Ft. Worth, Texas, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States