Sprayed-In Medicated Powder for Less-Invasive Epistaxis Treatment Using Tranexamic Acid: The Bloody SIMPLE Treatment Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cessation of epistaxis
研究概览
简要总结
Nosebleeds are very common, occurring in 60% of the population; in some patients, nosebleeds are a life-threatening emergency. To stop a nosebleed in the emergency department, doctors usually have to burn the nose (called cauterization) or insert pledgets (called nasal packing) into the nose to apply direct pressure to the bleeding site. Nasal packing can cause pain and discomfort at the time it is inserted in the nose and again when it is removed. In rare cases it can cause a range of complications: minor complications include scar bands in the nose, but serious complications of nasal packing have also occurred, including death. Nasal packing can also present risks to doctors, such as the risk of contracting airborne and bloodborne infections, like COVID-19 and HIV.
Tranexamic acid in pill form or given directly into a vein is a medication that is currently used for nosebleeds. This study looks to evaluate if tranexamic acid in powder form sprayed directly in the nose can be used as an alternative to cauterization or nasal packing for the treatment of nosebleeds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Capable of giving informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Adults 18 years or older
- •Male or female
- •Presenting to the ED with active, spontaneous epistaxis. Anterior versus posterior epistaxis will be identified a priori. Anterior epistaxis is operationally defined as active nasal bleeding that occurs anterior to the anterior limit of the middle turbinate, visible by anterior rhinoscopy.
排除标准
- •Prior sinonasal surgery within the preceding 1 month.
- •Patients who required medical treatment for epistaxis in the preceding 30 days.
- •Septum perforation.
- •Known history of bleeding disorders, including thrombocytopenia, hemophilia, hereditary hemorrhagic telangiectasia, or von Willebrand disease.
- •History of known thromboembolic disease, including subarachnoid hemorrhage, stroke, or TIA.
- •Known history of disease of the central nervous system, including seizures, convulsions, or intra-cerebral disease processes/lesions.
- •Known or suspected history of significant skull base trauma, including skull base fracture or cerebrospinal fluid leak.
- •Known history of acquired disturbances of colour vision.
- •Known hematuria or any bleeding related to the kidney.
- •Pregnant and/or lactating women.
- •History of known allergy or sensitivity to the study medication.
- •Presence of signs or symptoms of concomitant emergent conditions, including myocardial infarction, stroke, major trauma, shock, or hemodynamic instability.
- •Patients with other medical conditions including cognitive limitations or impairment due to substance abuse.
- •Patients with any other condition that, in the opinion of the investigator, may present an unreasonable risk to the patient, may make the patient unreliable, or may interfere with the study assessments.
- •Current participation in another interventional clinical trial.
研究组 & 干预措施
Tranexamic acid powder applied intranasally
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Cessation of epistaxis
时间窗: Day 1
Number of participants for whom epistaxis ceased after treatment
次要结局
- Time to cessation of epistaxis(Day 1)
- Total time in the Emergency Department(Day 1)
- Number of participants who returned to the Emergency Department for treatment of epistaxis(within the first 24 hours and the first 5 days after treatment)
- Pain of the treatment(Day 1)
研究者
Dr. Anne Conlin
Peterborough Regional Health Center Staff Otolaryngologist-Head & Neck Surgeon; Assistant Professor University of Ottawa
Peterborough Regional Health Centre