Copperhead Envenomation Observational Study

BTG

Status: Completed

Conditions: Copperhead Snake Envenomation

Study type: Observational

Funder types: Other

Identifiers

NCT01651299

BTG-PR005-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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