Copperhead Snake EnvenomationNCT01651299
Copperhead Envenomation Observational Study
An observational study of Copperhead Snake Envenomation, run by BTG International Inc. at 11 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copperhead Snake Envenomation
- How many people
- 20 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2012to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
St. Joseph Regional Health Center
Bryan, Texas, 77802
University of Virginia, Blue Ridge PC
Charlottesville, Virginia, 22908
Duke Medical Center
Durham, North Carolina, 27710
Harris Methodist Hospital
Fort Worth, Texas, 76104
Vidant Health
Greenville, North Carolina, 27834
University of Mississippi Medical Center
Jackson, Michigan, 39216
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
Virginia Commonwealth University Richmond
Richmond, Virginia, 23219
LSU Health Sciences Center
Shreveport, Louisiana, 71103
Washington University
St Louis, Missouri, 76104
Scott and White Hospital
Temple, Texas, 76508
About this study
Official title: Observational Study of Recovery From Copperhead Snake Envenomation
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.
- Conditions
- Copperhead Snake Envenomation
- Keywords
- copperhead snake envenomation
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Assessment of Recovery (PGAR)
Measured: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Numeric Pain Rating Scale (NPRS)
Measured: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Numeric Swelling Score (NSS)
Measured: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
SF36v2 (Acute Version)
Measured: Time of Discharge, Day 7, Day, 14, Day 21, and Day 28
Swelling Figure-of-8 Measurement
Measured: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Grip Strength
Measured: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Walking Speed
Measured: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Patient Global Impression of Change (PGIC)
Measured: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Return to Work/School/ADLs
Measured: Day 3, Day 7, Day 14, Day 21, and Day 28
Patient-Specific Functional Scale (PSFS)
Measured: Day 3, Day 7, Day 14, Day 21, and Day 28
WPAI:SHP V2
Measured: Day 3, Day 7, Day 14, Day 21, and Day 28
Disorders of the Arm, Shoulder, and Hand (DASH)
Measured: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Lower Extremity Functional Scale
Measured: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Copperhead Snake EnvenomationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTG International Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651299
- Sponsor's protocol ID
- BTG-PR005-001
- Status last verified
- Sep 2012
- First submitted
- 25 Jul 2012
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Recovery From Copperhead Snake Envenomation
- ClinicalTrials.gov ID
- NCT01651299
- Acronym / sponsor ID
- BTG-PR005-001
- Conditions
- Copperhead Snake Envenomation
- Keywords
- copperhead snake envenomation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BTG International Inc.University, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
- Derived from this study: PubMed 25975429Lavonas 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Copperhead Snake Envenomation, run by BTG International Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Assessment of Recovery (PGAR) (time frame: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01651299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013.