Observational Pilot Study With TachoSil as a Ventricular Sealant

Germans Trias i Pujol Hospital20 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Intraventricular Neoplasm

Interventions

TachoSilDRUG

Placement of TachoSil over the ventricular entry point in patients with periventricular lesions in order to avoid complications related to the ventricular entry.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Outcomes

Primary Outcomes

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.

Time frame: Up to 90 days after surgery

Secondary Outcomes

Incidence of percutaneous CSF leakage / pseudomeningocele/ hydrocephalus/meningitis

Percentage of complications with percutaneous CSF leakage pseudomeningocele/ hydrocephalus/meningitis

Time frame: Up to 90 days after surgery

Data from ClinicalTrials.gov

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