Control of Epistaxis With Surgiflo
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Days admitted to the hospital related to epistaxis
研究概览
简要总结
This is a blind trial to test if Surgiflo is effective in posterior epistaxis. After the investigators see than anterior tamponade is not effective stopping epistaxis, the investigators try using Surgiflo and if it does not work the investigators continue with a nasal catheter. This is the usual way to stop nasal bleeding, but is painful and has serious after-effects in the nose. Surgiflo is a hemostatic matrix that can be put into the nose, painlessly and easily. So the investigators think it can be useful controlling nasal bleeding, so the investigators could avoid to put nasal catheters in these patients.
详细描述
Epistaxis is one of the most frequent diseases in Otolaryngology emergencies. Most of them are anterior and stop with an anterior packing. Some of them does not stop with this, therefore the investigators have to put into the nose a catheter balloon. This is very painful and has many after-effects in the nose.
Surgiflo is a haemostatic matrix used for bleeding.
The investigators have design a trial to know if some people can benefit from Surgiflo instead to put a nasal catheter.
This a randomized trial with two arms. In one arm the investigators will put surgiflo and not in the other.The patient will be admitted to the hospital. The investigators will see the difference in the hospital staying and in the effects in the nose, including discomfort or pain. The investigators will report age, gender, other diseases or treatments of the patients,type and length of bleeding, transfusions needed, arterial tension, coagulation. To do that the investigators will make hematological tests for haemoglobin and coagulation. To know the discomfort of the device the investigators will give the patient an analog visual scale in the moment the investigators will put the device, the day after and in any of the next visits. The patient can go home again after 16h without bleeding and the investigators will see the patient again in the office after 15 days, 1, 3 and 6 months.
All the patients will receive the same analgesic protocol so the investigators can compare the discomfort.
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
- 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
- •Patients with epistaxis in emergency room.
- •Epistaxis does not stop with anterior nasal packing.
排除标准
- •Pregnancy
- •Allergy or intolerance to any component of Surgiflo.
- •Septal perforation.
- •Nasal surgery within 3 months previous to epistaxis.
- •Patients admitted to hospital for other reasons.
结局指标
主要结局
Days admitted to the hospital related to epistaxis
时间窗: From intervention (nasal catheter or Surgiflo) until 1 day after discharge
次要结局
- Discomfort and troubles related to the device used to treat epistaxis.(Within 6 months after tamponade)
研究者
Gonzalo de los Santos
MD, PhD
Hospital Universitario Ramon y Cajal