EUCTR2009-013056-71-GR进行中（未招募）不适用
TachoSil versus current practice in dura sealing techniques for theprevention of postoperative cerebrospinal fluid (CSF) leaks in patientsundergoing skull base surgery: An open label, randomised, controlled, multicentre,parallel group efficacy and safety trial. - TASALL -TachoSil Against Liquor Leak
ycomed Danmark ApS0 个研究点目标入组 726 人开始时间: 2009年11月19日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 726
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Pre-operative Inclusion Criteria – positive response required for inclusion:
- •1. Has written informed consent been obtained according to local regulations before any trial-related activities? (A trial-related activity is any procedure that would not have been performed during the routine management of the patient.)
- •2. Is the patient able and willing to comply with the procedures required for trial completion?
- •3. Is the patient 18 years or above?
- •4. Is the patient to non-trauma related neurosurgery for pathology of the skull base resulting in opening and closing of the dura mater? Dura substitution is allowed.
- •Intra-operative Inclusion Criteria – positive response required for inclusion:
- •5. Is the Surgical Wound Classification Class of class I (Clean surgical wound)?
- •6. Is the surgical approach/procedure consistent with skull base surgery? I.e. at least one of
- •the following:
- •a. Lateral approach to the foramen magnum: far lateral, extreme lateral,
- •anterolateral, posterolateral,
- •b. Approach to the jugular foramen: infratemporal, juxta condylar, transjugular,
- •c. Approach to the cerebello pontine (CP) angle and petrous apex retrosigmoïd,
- •translabyrinthine, retrolabyrinthine, transcochlear (limited transpetrosal),
- •d. Approach to the middle fossa: subtemporal (+/- petrous apex drilling),
- •pterional approach (any fronto temporal approach +/- orbitozygomatic
- •deposition),
- •e. Approach to the anterior fossa: subfrontal (uni or bilateral),
- •f. Approach to the midline posterior fossa or paramedian posterior fossa.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pre-operative Exclusion Criteria – negative response required for inclusion:
- •1. Has the patient participated in another clinical trial with an investigational drug or device within 28 days of inclusion in this trial? (Participation in non-interventional trials is allowed)
- •2. Has the patient previously participated in this trial?
- •3. Does the patient have evidence of an infection indicated by any one of the following:
- •fever >101°F / 38.5°C, white blood cells (WBC) <3.5/GL or >13.0/GL (if patient on steroid treatment up to 20.00/GL), positive urine culture, positive blood culture, positive chest Xray?
- •4. Does the patient have a known coagulopathy?
- •5. Does the patient have a history of allergic reactions after application of human
- •fibrinogen, human thrombin and / or collagen of any origin?
- •6. Is the patient anticipated to need additional neurosurgery within the follow-up period of Week 7±1 at the same surgical site?
- •For females of childbearing potential, i.e. neither postmenopausal (less than 12 month after the last menstruation) nor permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy):
- •7. Does the female patient use an unacceptable contraceptive method or method
- •ineffective at the time of randomisation, i.e. do not use a contraceptive method which is a highly effective method of birth control; defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomised partner?
- •8. Has the female patient had a positive serum pregnancy test taken up to 5 days prior to surgery? All females not documented as postmenopausal or permanently sterile must have a serum pregnancy test performed.
- •9. Breastfeeding?
- •Intra-operative Exclusion Criteria – negative response required for inclusion:
- •10. 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:
- •g. Trans basal approach,
- •h. Total petrosectomy,
- •i. Trans facial approach,
- •j. Trans sphenoïdal approach,
- •k. Endoscopic procedures,
- •l. Trans oral approach (and any extension: Le Fort, mandibulotomy).
- •11. Did the arachnoid membrane remained intact during surgery and/or the liquor containing system?
研究者
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