The purpose of this trial is to scientifically assess the performance and safety of TachoSil when used as a seal to prevent the leaking of brain fluid in patients who have undergone skull based surgery. TachoSil will be compared to the current practice already used within the hospital

Phase 1

Conditions: Skull base surgery for the prevention of postoperative cerebrospinal fluid (CSF) leaks
MedDRA version: 14.1Level: PTClassification code 10067908Term: NeurosurgerySystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2009-013056-71-BE

Lead Sponsor: Takeda Pharma A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 726

Inclusion Criteria

Pre-operative Inclusion Criteria – positive response required for inclusion:
1. Has written informed consent been obtained 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 considered 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 undergo non-trauma related neurosurgery for pathology of the skull base resulting in opening and closing of the dura mater? Dura substitution is allowed.
5. Has a CT or MRI scan of the head been performed within 4 month before screening?

Intra-operative Inclusion Criteria – positive response required for inclusion:
6. Is the Surgical Wound Classification Class of class I (Clean surgical wound)? (Clean wound definition: Uninfected surgical wounds in which no inflammation is encountered and the respiratory, alimentary, genital, or uninfected urinary tracts are not entered. In addition, clean wounds are primarily closed, and if necessary, drained with closed drainage)
7. 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 retrosigmoid
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.
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 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

Pre-operative Exclusion Criteria – negative response required for inclusion:
1. Has the patient been randomised in another clinical trial with an investigational medicinal product or device within 28 days before screening for this trial? (Participation in non-interventional studies is allowed)
2. Has the patient previously participated in this trial?
3. Does the patient have evidence of an infection within 5 days of surgery 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 > 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. Has the patient been subject to neurosurgery involving opening of the dura matter within the last 3 months before Screening for this trial?
7. Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura matter which may affect the efficacy evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Efficacy Follow-up 7±1 week?
8. Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura matter 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?

For females of childbearing potential, i.e. neither postmenopausal (less than 12 months after the last menstruation) nor permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy):
9. 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, vasectomised partner or double barrier contraception?
10. Has the contraceptive method been used too short to be effective?
11. Has the female patient had a positive serum pregnancy test taken within 5 days prior to surgery? All females not documented as postmenopausal or permanently sterile must have a serum pregnancy test performed.
12. Breastfeeding?

Intra-operative Exclusion Criteria – negative response required for inclusion:
13. The surgical approach/procedure is consistent with any transcranial or transfacial or combination of transcranial – transfacial approaches with wide defect in the skull base? any of the following:
a. Trans basal approach,
b. Total petrosectomy,
c. Trans facial approach,
d. Trans sphenoidal approach,
e. Endoscopic procedures,
f. Trans oral approach (and any extension: Le Fort, mandibulotomy).
14. The surgical approach is consistent with one of the following approaches?
a. Translabyrinthine approach
b. Retrolabyrinthine approach
c. Transcochlear (limited transpetrosal) approach
15. Did the arachnoid membrane and the CS containing system remain intact during surgery?
16. Does the patient have more than one dura opening (not including dura openings from extraventricular or lumbar drains)?
17. Has TachoSil, fibrin or polymer sealants been used during the current surgery prior to randomisatio

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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