NCT Number: NCT01651299
Copperhead Envenomation Observational Study
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Patient Global Assessment of Recovery (PGAR)
Time frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
-
Numeric Pain Rating Scale (NPRS)
Time frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
-
Numeric Swelling Score (NSS)
Time frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
-
SF36v2 (Acute Version)
Time frame: Time of Discharge, Day 7, Day, 14, Day 21, and Day 28
-
Swelling Figure-of-8 Measurement
Time frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
-
Grip Strength
Time frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
-
Walking Speed
Time frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
-
Patient Global Impression of Change (PGIC)
Time frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
-
Return to Work/School/ADLs
Time frame: Day 3, Day 7, Day 14, Day 21, and Day 28
-
Patient-Specific Functional Scale (PSFS)
Time frame: Day 3, Day 7, Day 14, Day 21, and Day 28
-
WPAI:SHP V2
Time frame: Day 3, Day 7, Day 14, Day 21, and Day 28
-
Disorders of the Arm, Shoulder, and Hand (DASH)
Time frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
-
Lower Extremity Functional Scale
Time frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Sponsors and collaborators
Lead sponsor
BTG International Inc.
Other
Registry information
Official study title
Observational Study of Recovery From Copperhead Snake Envenomation
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2013
- First posted
- Jul 27, 2012
- Registry last updated
- May 13, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.