Observational Pilot Study With TachoSil as a Ventricular Sealant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The main objective of the study is to evaluate the effectiveness and safety of TachoSil in operated patients who require opening of the ventricle.
研究概览
简要总结
The working hypothesis in this study is that after entering the cerebral ventricular system the sealing with TachoSil is effective and safe.
A more specific hypothesis is that the use of Tachosil for brain surgery with ventricular entry reduces the number of postoperative complications (hydrocephalus, CSF leak, meningitis and pseudomeningocele).
详细描述
Pilot observational study with medications (MOE), single-center, prospective and retrospective study with a group of patients operated on for periventricular lesions and with ventricular entry. As it is an infrequent type of surgery in our centre, the study includes a retrospective group (same surgery and use of TachoSil).
Primary objectives:
The main objective of the study is to evaluate the effectiveness and safety of TachoSil in patients who require ventricular entry.
To evaluate the effectiveness, the percentage of complications related to the ventricular entry during surgery are recorded. These complications are hydrocephalus, CSF leak, meningitis, and pseudomeningocele.
Secondary objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 who are candidates for elective supratentorial surgery (tumoral, vascular or epilepsy) that during the procedure present ventricular entry, being sealed by a patch of TachoSil
- •Ventricular entry during the procedure (intraoperative CSF outflow from the ventricle noticed by the surgeon)
- •Adults over the age of 18
- •Informed consent signed by the patient or representative (see annex 2). For cases in which the patient has died during this time a waiver of consent will be requested.
排除标准
- •Patients or representatives who do not want to sign the consent are excluded informed, pregnant women or those under 18 years of age.
研究组 & 干预措施
Patients with ventricular entry during surgery (vascular, tumoral and epilepsy).
Group of patients operated on for periventricular lesions with ventricular entry and placement of TachoSil directly over the area of ventricular opening in order to avoid complications.
干预措施: TachoSil (Drug)
结局指标
主要结局
The main objective of the study is to evaluate the effectiveness and safety of TachoSil in operated patients who require opening of the ventricle.
时间窗: Up to 90 days after surgery
To evaluate the effectiveness and the percentage of complications related to the ventricular entry during surgery. Taking into account hydrocephalus, CSF leak, meningitis and pseudomeningocele.
次要结局
- Incidence of percutaneous CSF leakage / pseudomeningocele/ hydrocephalus/meningitis(Up to 90 days after surgery)