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

• Conditions: Skull base surgery for the prevention of postoperative cerebrospinal fluid (CSF) leaks; MedDRA version: 12.0Level: PTClassification code 10067908Term: Neurosurgery

• Registration Number: EUCTR2009-013056-71-GR
• Lead Sponsor: ycomed Danmark ApS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-19
• Last Update Posted: 22 July 2013

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 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

Exclusion Criteria

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?

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified