Observational Pilot Study With TachoSil as a Ventricular Sealant

Germans Trias i Pujol Hospital

Status: Completed

Conditions: Intraventricular Neoplasm

Treatments: Drug: TachoSil

Study type: Observational

Funder types: Other

Identifiers

NCT05717335

PI-22-078 (Registry Identifier)

Tachosil-vent-2022

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Patients with ventricular entry during surgery (vascular, tumoral and epilepsy).

Description:

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.

Treatment:

Drug: TachoSil