Randomized Controlled Trial of Epoprostenol Versus Placebo in Addition to Standard Therapy for Severe Frostbite Injury
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Amputation Rate
研究概览
简要总结
Severe frostbite injury can result in significant lifelong disability and amputation. Various medicines, including intravenous vasodilators (prostaglandins/iloprost, pentoxifylline, buflomedil) along with thrombolytics (alteplase), have been described to counter tissue ischemia after rewarming, with poor quality of evidence. An in-class prostacyclin, epoprostenol, has similar pharmacodynamic properties to iloprost including vasodilation and platelet inhibition and has been used in peripheral tissue ischemia such as Raynaud's and scleroderma. In this trial, we will evaluate the effectiveness and safety of epoprostenol treatment for severe frostbite injury in addition to standard of care.
详细描述
Prospective single center placebo controlled randomized trial comparing epoprostenol versus placebo in patients already receiving the standard of care for frostbite, including alteplase. Hypothesis: treatment effect of epoprostenol will be greater than placebo, independent of prior alteplase administration. Standard of care in both groups includes immediate warm water rewarming, thrombolysis with alteplase if they are a thrombolytic candidate per our usual care, immediate therapeutic anticoagulation if received thrombolysis, and ibuprofen at the attending physician's discretion.
Study Aim: To determine the efficacy and safety of treatment with epoprostenol versus placebo in adult patients with severe frostbite injury.
Intervention Group: Standard of care plus epoprostenol intravenous infusion titrated based on tolerability for 5 days.
Control Group: Standard of care plus placebo (normal saline) infusion dosed and titrated to match epoprostenol infusion for 5 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Research Coordinators
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
- •Aged ≥ 18 years
- •Admitted to University of Colorado Hospital (UCH) Burn and Frostbite Center
- •Cauchy Grade 2-4 frostbite injury
- •Admission within 72 hours post-rewarming
排除标准
- •Patients unable to initiate therapy within 72 hours post-rewarming
- •Unsalvageable frostbite as defined by obvious necrosis of tissue, wet gangrene, or other condition requiring amputation (within the first week)
- •Anticipated death within 48 hours of admission
- •Pregnant or breastfeeding patients
- •Inability to obtain consent from patient or legally authorized representative (LAR) or proxy
- •Not a good candidate for treatment per treating physician or investigator
- •Patients with known allergy/hypersensitivity to epoprostenol
- •Current or planned receipt of other prostaglandin analog (iloprost and treprostinil)
- •Known congestive heart failure due to severe left ventricular systolic dysfunction (New York Heart Association (NYHA) class III/IV)
- •Known right heart failure (RHF)
- •Hypotension unresponsive to fluids and discontinuation of concomitant anti-hypertensives (mean arterial pressure (MAP) < 65 mmHg)
- •Known pulmonary hypertension
研究组 & 干预措施
Epoprostenol
Standard of care plus epoprostenol intravenous infusion titrated based on tolerability for 8 hours per day and up to 5 days of treatment.
干预措施: Standard of care plus Epoprostenol infusion for 8 hours (hrs) per day up to 5 days maximum (Drug)
Placebo (Normal Saline)
Standard of care plus placebo infusion dosed and titrated to match epoprostenol infusion for 8 hours per day and up to 5 days of treatment.
干预措施: Standard of Care + Placebo (Normal Saline)infusion for 8 hours per day up to 5 days maximum (Drug)
结局指标
主要结局
Amputation Rate
时间窗: from enrollment to the end of treatment when client returns for clinic visit at 90 days.
Amputation rate within 90 days of frostbite injury, defined as number of amputations per number of digits affected.
次要结局
- Hennepin frostbite score change(from admission to final healing to day 90)
- Preserved Digit Segments(from admission to final healing to Day 90)
- Change in Perfusion Imaging (fluorescence intravenous indocyanine green)(from admission to final imaging at day 7)
- Change in Technetium Bone Scans(from admission to final imaging at day 7)