TachoSil® Versus Current Practice in Dura Sealing Techniques for the Prevention of Post-operative Cerebrospinal Fluid (CSF) Leaks in Patients Undergoing Skull Base Surgery: An Open Label, Randomised, Controlled, Multi-centre, Parallel Group Efficacy and Safety Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 726
- 试验地点
- 40
- 主要终点
- Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure
研究概览
简要总结
The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil® as an adjunct in sealing the dura mater.
The trial population will consist of 726 randomised (1:1) patients elected for skull base surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1 weeks and safety follow-up 28±2 weeks after surgery.
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
- •Main Inclusion Criteria (Positive response):
- •Is the surgical approach/procedure consistent with skull base surgery? I.e. one of the following:
- •Lateral approach to the foramen magnum: Far lateral, extreme lateral, anterolateral, posterolateral
- •Approach to the jugular foramen: Infratemporal, juxta condylar, transjugular
- •Approach to the cerebello pontine (CP) angle and petrous apex retrosigmoid
- •Approach to the middle fossa: Subtemporal (+/- petrous apex drilling), pterional approach (any fronto temporal approach +/- orbitozygomatic deposition)
- •Approach to the anterior fossa: Subfrontal (uni or bilateral)
- •Approach to the midline posterior fossa
排除标准
- •(Negative response):
- •Has the patient been subject to neurosurgery involving opening of the dura mater within the last 3 months?
- •Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the efficacy evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Efficacy Follow-up Week 7±1 week?
- •Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the safety evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Safety Follow-up Week 28±2 weeks?
- •The surgical approach/procedure is consistent with any transcranial or transfacial or combination of transcranial - transfacial approaches with wide defect in the skull base? I.e. any of the following:
- •Trans basal approach
- •Total petrosectomy
- •Trans facial approach
- •Trans sphenoidal approach
- •Endoscopic procedures
- •Trans oral approach (and any extension: Le Fort, mandibulotomy)
- •The surgical approach is consistent with one of the following approaches?
- •Translabyrinthine approach
- •Retrolabyrinthine approach
- •Transcochlear (limited transpetrosal) approach
- •Did the arachnoid membrane and the CSF containing system remain intact during surgery?
- •Does the patient have more than one dura opening (not including dura openings from extraventricular or lumbar drains)?
- •Has TachoSil, fibrin or polymer sealants been used during the current surgery prior to randomization?
结局指标
主要结局
Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure
时间窗: Up to 8 Weeks (7 Weeks ± 1 Week)
An assessment was performed daily from randomization to Day of Discharge and at the Efficacy Follow-up visit at week 7 ± 1 week. Clinically evident cerebrospinal fluid leak was confirmed by: 1. Glucose concentration test and/or 2. β-2-transferrin test. A clinically evident pseudomeningocele was considered to be present post-operatively if the following criteria were fulfilled: 1. A subcutaneous, visible/palpable fluctuant fluid accumulation was noted at the site of the surgical incision or adjacent to it; 2. It is suspected the fluid accumulation is cerebrospinal fluid. A treatment failure was defined as application of a new and/or different treatment after application of the study treatment or a third application of (or part of) the selected study treatment on the outside of the dura.
次要结局
- Percentage of Participants With Post-Surgical Non-Clinically Evident Post-Operative Pseudomeningocele(Assessment at least once prior to discharge from neurosurgical ward, with the expected discharge from neurosurgical ward after an average of 10 days (Up to 28 Weeks))