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CompletedNCT01651299Updated May 13, 2013

Copperhead Envenomation Observational Study

An observational study in Copperhead Snake Envenomation, sponsored by BTG International Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-13.

Sponsored by BTG International Inc. · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Copperhead Snake Envenomation

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Keywords

  • copperhead snake envenomation
03

In context

Snake Bites

38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.

This study's enrollment of 20 is below the median of 99 across 19 observational studies indexed under Snake Bites.

Browse Snake Bites studies →

Lead sponsor

BTG International Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • 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

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Time perspective
Prospective
Enrollment
20 participants (actual)
06

What researchers measure

Primary outcomes

  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

07

Study locations

11 sites
  • University of Kentucky Chandler Medical Center
    Lexington, Kentucky 40536, United States
  • LSU Health Sciences Center
    Shreveport, Louisiana 71103, United States
  • University of Mississippi Medical Center
    Jackson, Michigan 39216, United States
  • Washington University
    St. Louis, Missouri 76104, United States
  • Duke Medical Center
    Durham, North Carolina 27710, United States
  • Vidant Health
    Greenville, North Carolina 27834, United States
  • St. Joseph Regional Health Center
    Bryan, Texas 77802, United States
  • Harris Methodist Hospital
    Ft. Worth, Texas 76104, United States
  • Scott and White Hospital
    Temple, Texas 76508, United States
  • University of Virginia, Blue Ridge PC
    Charlottesville, Virginia 22908, United States
  • Virginia Commonwealth University Richmond
    Richmond, Virginia 23219, United States
08

References and documents

Publications

  • 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. PubMed 25975429 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01651299
Lead sponsor
BTG International Inc.
Responsible party
Sponsor
First posted
Jul 27, 2012
Start date
Jul 2012
Primary completion
Nov 2012
Completion
Apr 2013
Last update
May 13, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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