DRKS00019107招募中3 期
Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: a randomized multi-center phase III trial - AkNiPro2
niversitätsklinikum Halle Saale, Klinik und Poliklinik für Neurochirurgie0 个研究点目标入组 336 人开始时间: 2020年5月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1.Male and female adults age = 18 years
- •2.Vestibular schwannomas (Koos I-IV) with indication for surgery
- •3.Preoperative pure-tone audiogram (not older than 3 months prior to surgery), hearing function according to Gardner-Robertson scale (GR) 1-3 (Air-conduction PTA (0.5-3kHz) <90 dB HL)
- •4.Preoperative MRI (not older than 6 months prior to surgery)
- •5.Written informed consent obtained according to international guidelines and local laws
- •6. Ability to understand and give informed consent.
- •7.Safe contraception measures for males and females. Procedures with a pearl index of less than 1% apply as safe pregnancy prevention measures.
排除标准
- •1. Hearing function GR 4-5 (Air-conduction PTA (0.5-3kHz) >=90 dB HL)
- •2. conductive hearing loss at affected side (mean air-bone gap (0.5, 1, 2, 3 kHz) >10 dB) if
- •bone-conduction is measurable
- •3. Previously irradiated or surgical treated VS
- •4. Neurofibromatosis, other brain tumors, other reasons for inoperability
- •5. Pregnancy and lactation period
- •6. Known hypersensitivity to nimodipine or any of the excipients (ethanol, Macrogol, sodiumcitrate, citric acid) to be used for nimodipine infusion
- •7. History of (reformed alcoholics) or persistent abuse of alcohol
- •8. Known current kidney or liver insufficiency
- •9. Any medical condition that in the opinion of the investigator would not permit
- •participation in the clinical trial.
- •10. Unstable angina pectoris and/or Myocardial infarction during the last four weeks before
- •start of treatment
- •11. severe, uncontrolled, symptomatic hypotension at inclusion
- •12. Subjects with psychological, psychiatric, neurological, familial, sociological, or
- •geographical conditions that do not permit compliance with the protocol as well as
- •officially and/or legally accomodated persons
- •13. Participation in another interventional trial simultaneously and within the last 30 days
- •prior to inclusion (registries or observational studies allowed)
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