Clinical Trial: Copperhead Envenomation Observational Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Observational Study of Recovery From Copperhead Snake 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 Summary: 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.
Sponsor: BTG International Inc.

Current Primary Outcome:

  • 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

    Original Primary Outcome:

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: BTG International Inc.

    Dates:
    Date Received: July 25, 2012
    Date Started: July 2012
    Date Completion:
    Last Updated: May 10, 2013
    Last Verified: September 2012