Copperhead Envenomation Observational Study



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:July 2012
End Date:December 2012

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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.


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.

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
We found this trial at
11
sites
Shreveport, Louisiana
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Shreveport, LA
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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St. Louis, MO
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Bryan, TX
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Charlottesville, Virginia 22908
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Charlottesville, VA
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Durham, North Carolina 27708
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Durham, NC
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Ft. Worth, Texas 76104
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Ft. Worth, TX
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Greenville, North Carolina 27834
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Greenville, NC
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Jackson, MI
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Lexington, KY
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Richmond, VA
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Temple, Texas 76508
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Temple, TX
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