Copperhead Snake Envenomation Clinical Trial
Official title:
Observational Study of Recovery From Copperhead Snake Envenomation
| Verified date | September 2012 |
| Source | BTG International Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | April 2013 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | St. Joseph Regional Health Center | Bryan | Texas |
| United States | University of Virginia, Blue Ridge PC | Charlottesville | Virginia |
| United States | Duke Medical Center | Durham | North Carolina |
| United States | Harris Methodist Hospital | Ft. Worth | Texas |
| United States | Vidant Health | Greenville | North Carolina |
| United States | University of Mississippi Medical Center | Jackson | Michigan |
| United States | University of Kentucky Chandler Medical Center | Lexington | Kentucky |
| United States | Virginia Commonwealth University Richmond | Richmond | Virginia |
| United States | LSU Health Sciences Center | Shreveport | Louisiana |
| United States | Washington University | St. Louis | Missouri |
| United States | Scott and White Hospital | Temple | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| BTG International Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patient Global Assessment of Recovery (PGAR) | Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 | No | |
| Primary | Numeric Pain Rating Scale (NPRS) | Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 | No | |
| Primary | Numeric Swelling Score (NSS) | Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 | No | |
| Primary | SF36v2 (Acute Version) | Time of Discharge, Day 7, Day, 14, Day 21, and Day 28 | No | |
| Primary | Swelling Figure-of-8 Measurement | Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 | No | |
| Primary | Grip Strength | Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 | No | |
| Primary | Walking Speed | Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 | No | |
| Primary | Patient Global Impression of Change (PGIC) | Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 | No | |
| Primary | Return to Work/School/ADLs | Day 3, Day 7, Day 14, Day 21, and Day 28 | No | |
| Primary | Patient-Specific Functional Scale (PSFS) | Day 3, Day 7, Day 14, Day 21, and Day 28 | No | |
| Primary | WPAI:SHP V2 | Day 3, Day 7, Day 14, Day 21, and Day 28 | No | |
| Primary | Disorders of the Arm, Shoulder, and Hand (DASH) | Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 | No | |
| Primary | Lower Extremity Functional Scale | Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 | No |