Copperhead Envenomation Observational Study

Completed

Conditions studied: Copperhead Snake Envenomation

In brief

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.

Key facts

Study ID

NCT01651299

Run by

BTG International Inc.

People needed

20

Starts

2012-07-01

Expected to finish

2013-04-01

Last updated by the study team

2013-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• LSU Health Sciences Center — Shreveport, Louisiana, United States
• University of Mississippi Medical Center — Jackson, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Duke Medical Center — Durham, North Carolina, United States
• Vidant Health — Greenville, North Carolina, United States
• St. Joseph Regional Health Center — Bryan, Texas, United States
• Harris Methodist Hospital — Fort Worth, Texas, United States
• Scott and White Hospital — Temple, Texas, United States
• University of Virginia, Blue Ridge PC — Charlottesville, Virginia, United States
• Virginia Commonwealth University Richmond — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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