Copperhead Envenomation Observational Study

• ClinicalTrials.gov Identifier: NCT01651299
• Recruitment Status: Completed
• First Posted: July 27, 2012
• Last Update Posted: May 13, 2013
• Sponsor: BTG International Inc.
• Information provided by (Responsible Party): BTG International Inc.

Study Description

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.

Condition or disease
Copperhead Snake Envenomation

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Time Perspective: Prospective
• Official Title: Observational Study of Recovery From Copperhead Snake Envenomation
• Study Start Date: July 2012
• Actual Primary Completion Date: November 2012
• Actual Study Completion Date: April 2013

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Patient Global Assessment of Recovery (PGAR) [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ]
2. Numeric Pain Rating Scale (NPRS) [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ]
3. Numeric Swelling Score (NSS) [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ]
4. SF36v2 (Acute Version) [ Time Frame: Time of Discharge, Day 7, Day, 14, Day 21, and Day 28 ]
5. Swelling Figure-of-8 Measurement [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ]
6. Grip Strength [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ]
7. Walking Speed [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ]
8. Patient Global Impression of Change (PGIC) [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ]
9. Return to Work/School/ADLs [ Time Frame: Day 3, Day 7, Day 14, Day 21, and Day 28 ]
10. Patient-Specific Functional Scale (PSFS) [ Time Frame: Day 3, Day 7, Day 14, Day 21, and Day 28 ]
11. WPAI:SHP V2 [ Time Frame: Day 3, Day 7, Day 14, Day 21, and Day 28 ]
12. Disorders of the Arm, Shoulder, and Hand (DASH) [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ]
13. Lower Extremity Functional Scale [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

United States, Kentucky

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States, 40536

United States, Louisiana

LSU Health Sciences Center

Shreveport, Louisiana, United States, 71103

United States, Michigan

University of Mississippi Medical Center

Jackson, Michigan, United States, 39216

United States, Missouri

Washington University

St. Louis, Missouri, United States, 76104

United States, North Carolina

Duke Medical Center

Durham, North Carolina, United States, 27710

Vidant Health

Greenville, North Carolina, United States, 27834

United States, Texas

St. Joseph Regional Health Center

Bryan, Texas, United States, 77802

Harris Methodist Hospital

Ft. Worth, Texas, United States, 76104

Scott and White Hospital

Temple, Texas, United States, 76508

United States, Virginia

University of Virginia, Blue Ridge PC

Charlottesville, Virginia, United States, 22908

Virginia Commonwealth University Richmond

Richmond, Virginia, United States, 23219

Sponsors and Collaborators

BTG International Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: BTG International Inc.
• ClinicalTrials.gov Identifier: NCT01651299
• Other Study ID Numbers: BTG-PR005-001
• First Posted: July 27, 2012
• Last Update Posted: May 13, 2013
• Last Verified: September 2012

Keywords provided by BTG International Inc.:

copperhead snake envenomation

Additional relevant MeSH terms:

Poisoning; Snake Bites; Chemically-Induced Disorders; Bites and Stings; Wounds and Injuries