The objectives are to assess the efficacy and safety of TachoSil in sealing the dura mater to prevent postoperative CSF-leakage / clinically evident pseudomeningocele following skull base surgery, by comparison to current practice.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the occurrence of either a clinically evident CSF-leak
or a clinically evident pseudomeningocele.
Secondary outcome
The secondary endpoint is defined as the incidence of non-clinically evident
epidural fluid collections found on CT- or MRI-scans and will be evaluated
post-operatively until the Follow-up visit.
Background summary
Currently no unanimous consensus of how to seal the dura mater has been
generally adopted as being the gold standard. TachoSil is currently registered
for haemostasis, but is already being used for sealing the dura mater in
neurosurgery. This trial has being set up to investigate the efficacy of
TachoSil in the neurosurgery. As TachoSil is aimed to be introduced on the US
market, the trial encompasses the need of a partially US based trial.
Study objective
The objectives are to assess the efficacy and safety of TachoSil in sealing the
dura mater to prevent postoperative CSF-leakage / clinically evident
pseudomeningocele following skull base surgery, by comparison to current
practice.
Study design
This is an open label, randomised, controlled, parallel-group, multicenter,
phase III trial.
Intervention
Patients will be randomised for TachoSil or current practice.
Study burden and risks
Patients have 5 visits: screening, day of surgery, day 3, day of discharge and
a follow-up visit.
At the screening visit, a complete blood investigation will be performed. In
case of suspection of an infection, the physician can decide to have additional
cultures of blood/cerebrospinal fluid/urine.
CT-/MRI-scan at screening and on day 3. If neccesary also at discharge and
follow-up.
Chest X-ray if the physician suspects a lung infection.
3 x physical examination
3 x vital signs
TachoSil can have the following side-effects:
o Fever may occur commonly (less than 10%)
o Hypersensitivity or allergic reactions (which may include angioedema [rapid
swelling of the skin], burning and stinging of the application site,
bronchospasm [sudden constriction of the muscles in the walls of the vessels in
the lungs], chills, flushing, generalised urticaria [skin rash], headache,
hives, hypotension, lethargy, nausea, restlessness, tachycardia [heart rate
that exceeds the normal range for a resting heart rate], tightness of the
chest, tingling, vomiting, wheezing) may occur uncommonly (less than 1%). In
isolated cases, these reactions may progress to severe anaphylaxis.
o Antibodies against components of product may occur rarely (less than 0.1%)
o Thromboembolic (blockage of blood flow) complications may occur if the
preparation is unintentionally applied intra vascularly (inside blood vessels)
(less than 0.01%)
Langebjerg 1
4000 Roskilde
DK
Langebjerg 1
4000 Roskilde
DK
Listed location countries
Age
Inclusion criteria
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), pteronial approach (any fronto temporal approach +/- orbitozygomatic deposition),
e. Approach to the anterior fossa: subfrontal (uni or bilateral),
f. Approach to the midline posterior fossa.
Exclusion criteria
* Has the patient been subject to emergency surgery within the last 3 months i.e. all non-elective surgery?
* Is the patient expected to need additional neurosurgery within the follow-up periodof Week 7±1 at the same surgical site?
* Is the surgical approach/procedure 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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-013056-71-NL |
| CCMO | NL30063.091.09 |