Observational Pilot Study With TachoSil as a Ventricular Sealant

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Pilot Study With TachoSil as a Ventricular Sealant

Conditions
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Intraventricular Neoplasm

Intervention / Treatment
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* Drug: TachoSil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with ventricular entry during surgery (vascular, tumoral and epilepsy).<br>Group of patients operated on for periventricular lesions with ventricular entry and placement of TachoSil directly over the area of ventricular opening in order to avoid complications. | Drug: TachoSil<br>* Placement of TachoSil over the ventricular entry point in patients with periventricular lesions in order to avoid complications related to the ventricular entry.<br>* Other names: TachoSil is a sponge sealant patch that is coated with the active substances human fibrinogen and human thrombin.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main objective of the study is to evaluate the effectiveness and safety of TachoSil in operated patients who require opening of the ventricle. | To evaluate the effectiveness and the percentage of complications related to the ventricular entry during surgery. Taking into account hydrocephalus, CSF leak, meningitis and pseudomeningocele. | Up to 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of percutaneous CSF leakage / pseudomeningocele/ hydrocephalus/meningitis | Percentage of complications with percutaneous CSF leakage pseudomeningocele/ hydrocephalus/meningitis | Up to 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricle opening, ventricular entry, Complication, Pseudomeningocele, Cerebrospinal fluid leakage, Meningitis