Clinical trial NCT05717335: Observational Pilot Study With TachoSil as a Ventricular Sealant
Official title: Observational Pilot Study With TachoSil as a Ventricular Sealant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraventricular Neoplasm
Keywords: Ventricle opening
ventricular entry
Complication
Pseudomeningocele
Cerebrospinal fluid leakage
Meningitis
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective supratentorial craniotomy due to periventricular lesions (tumoral, vascular or epilepsy) with ventricular entry during the procedure. The TachoSil patch is used as a ventricular sealant. A part of the population will be collected prospectively and retrospective cases operated using the same systematic will also be collected.

Brief summary: The working hypothesis in this study is that after entering the cerebral ventricular system the sealing with TachoSil is effective and safe.

A more specific hypothesis is that the use of Tachosil for brain surgery with ventricular entry reduces the number of postoperative complications (hydrocephalus, CSF leak, meningitis and pseudomeningocele).

Detailed description: Pilot observational study with medications (MOE), single-center, prospective and retrospective study with a group of patients operated on for periventricular lesions and with ventricular entry. As it is an infrequent type of surgery in our centre, the study includes a retrospective group (same surgery and use of TachoSil).

Primary objectives:

The main objective of the study is to evaluate the effectiveness and safety of TachoSil in patients who require ventricular entry.

To evaluate the effectiveness, the percentage of complications related to the ventricular entry during surgery are recorded. These complications are hydrocephalus, CSF leak, meningitis, and pseudomeningocele.

Secondary objectives

* Intraoperative incidence of fistula after application of the ventricular patch at 20cm PEEP H20 (efficacy objective).
* Incidence of clinically confirmed percutaneous fistula during the first 30 days after surgery (efficacy objective).
* Incidence of pseudomeningocele \>20cc confirmed with MRI or ultrasound (effectiveness objective).
* Incidence of radiologically confirmed hydrocephalus during the first 90 days after of the surgery.
* Record the percentage of use of other dural sealants
* Evaluate the cost effectiveness of the product.
* Describe the adverse effects related to the product
* Incidence of complication requiring reintervention within 30 days to the main surgery (safety objective).
* Assessment of the complications that are avoided: readmissions.

Study period: from December 2020 to December 2023.

Eligibility criteria: Inclusion Criteria:

* Patients who are candidates for elective supratentorial surgery (tumoral, vascular or epilepsy) that during the procedure present ventricular entry, being sealed by a patch of TachoSil
* Ventricular entry during the procedure (intraoperative CSF outflow from the ventricle noticed by the surgeon)
* Adults over the age of 18
* Informed consent signed by the patient or representative (see annex 2). For cases in which the patient has died during this time a waiver of consent will be requested.

Exclusion Criteria:

* Patients or representatives who do not want to sign the consent are excluded informed, pregnant women or those under 18 years of age.

Primary outcomes:
measure: The main objective of the study is to evaluate the effectiveness and safety of TachoSil in operated patients who require opening of the ventricle.
timeFrame: Up to 90 days after surgery
Secondary outcomes:
measure: Incidence of percutaneous CSF leakage / pseudomeningocele/ hydrocephalus/meningitis
timeFrame: Up to 90 days after surgery
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Pilar Teixidor Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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