Observational Study of Recovery From Copperhead Snake Envenomation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 11
- 主要终点
- Walking Speed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Walking Speed
时间窗: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Patient Global Assessment of Recovery (PGAR)
时间窗: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Numeric Pain Rating Scale (NPRS)
时间窗: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Numeric Swelling Score (NSS)
时间窗: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
SF36v2 (Acute Version)
时间窗: Time of Discharge, Day 7, Day, 14, Day 21, and Day 28
Swelling Figure-of-8 Measurement
时间窗: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Grip Strength
时间窗: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Patient Global Impression of Change (PGIC)
时间窗: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Return to Work/School/ADLs
时间窗: Day 3, Day 7, Day 14, Day 21, and Day 28
Patient-Specific Functional Scale (PSFS)
时间窗: Day 3, Day 7, Day 14, Day 21, and Day 28
WPAI:SHP V2
时间窗: Day 3, Day 7, Day 14, Day 21, and Day 28
Disorders of the Arm, Shoulder, and Hand (DASH)
时间窗: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Lower Extremity Functional Scale
时间窗: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
次要结局
未报告次要终点