Use of Microporous Polysaccharide Hemospheres (MPH) in Management of Acute Epistaxis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of subjects with resolution of bleed
研究概览
简要总结
The purpose of this study is to compare a new treatment for nosebleeds to the treatment that has been used for many years.
详细描述
Nosebleeds are a common condition which affect many Americans every day.The standard treatment in this hospital for nosebleeds that do not resolve with squeezing the nose or nasal spray is to place a nasal packing (aka nasal tampon) into the nose. This is an effective treatment in most cases, but patients may find it to be uncomfortable. The investigators will be comparing the standard nasal packing with a new type of powder which may also stop nosebleeds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •acute epistaxis who have failed conservative measures (including application of pressure and application of oxymetazoline spray) and for which the Otolaryngology service has been consulted
- •must be alert and oriented
- •hemodynamically stable with a hemoglobin greater than 9 g/dL
- •cooperative
排除标准
- •unable to consent or cooperate
- •history of hereditary hemorrhagic telengectasias
- •hemophilia
- •clotting factor deficiencies
- •history of prior surgery for epistaxis control
- •nasal trauma
- •recent sinonasal surgery
- •hemodynamic instability
- •posterior bleed (as determined by Ear, Nose, Throat physician)
- •visibly bleeding vessel
- •allergy to product
- •current diabetic ketoacidosis
研究组 & 干预措施
Microporous Polysaccharide Hemospheres (MPH)
Subjects with acute epistaxis will receive microporous polysaccharide hemospheres (Arista) powder. In the event that Arista fails to assist in resolving nosebleed in 15 minutes, subjects will be promptly escalated to the control group and will receive Merocel.
干预措施: Microporous Polysaccharide Hemospheres (Device)
Microporous Polysaccharide Hemospheres (MPH)
Subjects with acute epistaxis will receive microporous polysaccharide hemospheres (Arista) powder. In the event that Arista fails to assist in resolving nosebleed in 15 minutes, subjects will be promptly escalated to the control group and will receive Merocel.
干预措施: Nasal Tampon (Device)
Merocel (Control)
Subjects with acute epistaxis will receive standard-of-care treatment, nasal tampon (Merocel). In the event that Merocel fails to assist in resolving nosebleed in 15 minutes, subjects will be promptly escalated to the MPH group and will receive Arista powder.
干预措施: Microporous Polysaccharide Hemospheres (Device)
Merocel (Control)
Subjects with acute epistaxis will receive standard-of-care treatment, nasal tampon (Merocel). In the event that Merocel fails to assist in resolving nosebleed in 15 minutes, subjects will be promptly escalated to the MPH group and will receive Arista powder.
干预措施: Nasal Tampon (Device)
结局指标
主要结局
Number of subjects with resolution of bleed
时间窗: 15 minutes (average time to resolve bleeding)
Resolution of bleeding is determined by cessation of blood flow anteriorly from the nares as well as posteriorly in the pharynx. This will be determined by the otolaryngology resident or attending managing the patient during the study.
次要结局
- Time until resolution of bleeding(15 minutes (average time to resolve bleeding))
研究者
Oswaldo A Henriquez
Principal Investigator
Emory University