Copperhead Envenomation Observational Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01651299
First received: July 25, 2012
Last updated: May 10, 2013
Last verified: September 2012
  Purpose

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
Copperhead Snake Envenomation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Study of Recovery From Copperhead Snake Envenomation

Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Patient Global Assessment of Recovery (PGAR) [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ] [ Designated as safety issue: No ]
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ] [ Designated as safety issue: No ]
  • Numeric Swelling Score (NSS) [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ] [ Designated as safety issue: No ]
  • SF36v2 (Acute Version) [ Time Frame: Time of Discharge, Day 7, Day, 14, Day 21, and Day 28 ] [ Designated as safety issue: No ]
  • Swelling Figure-of-8 Measurement [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ] [ Designated as safety issue: No ]
  • Grip Strength [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ] [ Designated as safety issue: No ]
  • Walking Speed [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ] [ Designated as safety issue: No ]
  • Return to Work/School/ADLs [ Time Frame: Day 3, Day 7, Day 14, Day 21, and Day 28 ] [ Designated as safety issue: No ]
  • Patient-Specific Functional Scale (PSFS) [ Time Frame: Day 3, Day 7, Day 14, Day 21, and Day 28 ] [ Designated as safety issue: No ]
  • WPAI:SHP V2 [ Time Frame: Day 3, Day 7, Day 14, Day 21, and Day 28 ] [ Designated as safety issue: No ]
  • Disorders of the Arm, Shoulder, and Hand (DASH) [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ] [ Designated as safety issue: No ]
  • Lower Extremity Functional Scale [ Time Frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2012
Study Completion Date: April 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651299

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

No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01651299     History of Changes
Other Study ID Numbers: BTG-PR005-001
Study First Received: July 25, 2012
Last Updated: May 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by BTG International Inc.:
copperhead snake envenomation

Additional relevant MeSH terms:
Snake Bites
Bites and Stings
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 22, 2014