Clinical trial NCT01651299: Copperhead Envenomation Observational Study
Official title: Observational Study of Recovery From Copperhead Snake Envenomation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Copperhead Snake Envenomation
Keywords: copperhead snake envenomation
Lead sponsor: BTG International Inc.
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Global Assessment of Recovery (PGAR)
timeFrame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
measure: Numeric Swelling Score (NSS)
timeFrame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
measure: SF36v2 (Acute Version)
timeFrame: Time of Discharge, Day 7, Day, 14, Day 21, and Day 28
measure: Swelling Figure-of-8 Measurement
timeFrame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
measure: Grip Strength
timeFrame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
measure: Walking Speed
timeFrame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
measure: Patient Global Impression of Change (PGIC)
timeFrame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
measure: Return to Work/School/ADLs
timeFrame: Day 3, Day 7, Day 14, Day 21, and Day 28
measure: Patient-Specific Functional Scale (PSFS)
timeFrame: Day 3, Day 7, Day 14, Day 21, and Day 28
measure: WPAI:SHP V2
timeFrame: Day 3, Day 7, Day 14, Day 21, and Day 28
measure: Disorders of the Arm, Shoulder, and Hand (DASH)
timeFrame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
measure: Lower Extremity Functional Scale
timeFrame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Michigan
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Vidant Health
state: North Carolina
city: Bryan
country: United States
facility: St. Joseph Regional Health Center
state: Texas
city: Ft. Worth
country: United States
facility: Harris Methodist Hospital
state: Texas
city: Temple
country: United States
facility: Scott and White Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia, Blue Ridge PC
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Richmond
state: Virginia
Study officials:
References:
citation: 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.