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Sponsored by: |
Carolinas Healthcare System |
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Information provided by: | Carolinas Healthcare System |
ClinicalTrials.gov Identifier: | NCT00303303 |
Most patients bitten by copperhead snakes do not currently receive antivenom. Some snakebite victims have long term problems with the function of the limb that was bitten. This study will determine whether early administration of antivenom to patients with mild to moderate copperhead snakebites reduces long-term complications.
Condition | Intervention | Phase |
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Snake Envenomation |
Biological: Crotaline Polyvalent Immune Fab (ovine) (active initial and maintenance therapy) Biological: Crotaline Immune Fab (ovine) (active initial therapy; placebo maintenance therapy) Biological: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Efficacy of Crotaline Fab Antivenom for Copperhead Snake Envenomations |
Estimated Enrollment: | 25 |
Study Start Date: | April 2005 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Active initial and maintenance therapy
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Biological: Crotaline Polyvalent Immune Fab (ovine) (active initial and maintenance therapy)
Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; active maintenance therapy with 2 vials administered 6, 12, and 18 hours after initial control is achieved.
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2: Experimental
Active initial therapy; placebo maintenance therapy.
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Biological: Crotaline Immune Fab (ovine) (active initial therapy; placebo maintenance therapy)
Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; placebo maintenance therapy administered 6, 12, and 18 hours after initial control is achieved.
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3: Placebo Comparator
Placebo initial and maintenance therapy.
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Biological: Placebo
Placebo therapy in place of initial and maintenance antivenom therapy. Note that open-label rescue therapy is mandated if the envenomation syndrome becomes severe, or if progression of envenomation signs/symptoms has not spontaneously halted by 6 hours.
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This study seeks to answer three important questions about the role of ovine (sheep-derived) antivenom in the treatment of people bitten by copperhead snakes (Agkistrodon contortrix):
Patients are eligible for enrollment if they have been bitten by a snake positively identified as a copperhead within 6 hours of enrollment, if they have signs of mild or moderate severity envenomation, and if contraindications are not present.
After appropriate informed consent, patients are randomized to receive:
A. initial stabilizing dose of antivenom, followed by maintenance therapy,
B. initial stabilizing dose of antivenom followed by placebo in lieu of maintenance therapy, or
C. placebo for both initial dose and maintenance.
All laboratory testing, pain medication, hospitalization, and other therapies are standard for snakebite of this severity. If at any time the envenomation becomes severe, antivenom is administered.
In addition to the standard assessments performed on all snakebite victims (swelling, pain, vital signs, blood clotting, complications of therapy), patients in this study receive formal assessments of the function of the envenomated limb. This assessment uses the AMA disability rating system and the American Academy of Orthopedic Surgeons' Normative Outcomes Study questionnaire do determine how well the limbs function and how well the limbs perform and how much any remaining problems interfere with the patients' long-term happiness and ability to perform common activities of daily living.
Ages Eligible for Study: | 12 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Carolinas Medical Center | |
Charlotte, North Carolina, United States, 28232 | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, South Carolina | |
Richland Memorial Hospital | |
Columbia, South Carolina, United States, 29203 | |
United States, Virginia | |
Medical College of Virigina/Virginia Commonwealth University Hospital | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | William P Kerns, MD | Carolinas Medical Center |
Responsible Party: | Carolinas HealthCare System ( William P. Kerns III, MD ) |
Study ID Numbers: | 06-01-12B |
Study First Received: | March 14, 2006 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00303303 |
Health Authority: | United States: Institutional Review Board |
Snake envenomation Antivenins Disability evaluation Activities of daily living |
Antivenins Poisoning Disorders of Environmental Origin Bites and Stings Snake Bites |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |