Observational Pilot Study With TachoSil as a Ventricular Sealant

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intraventricular Neoplasm Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Ventricle Neoplasms Cerebrospinal Fluid Leak Craniocerebral Trauma Meningitis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neuroinflammatory Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tachosil

Drug

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

Other names: TachoSil is a sponge sealant patch that is coated with the active substances human fibrinogen and human thrombin.

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.

Time frame: Up to 90 days after surgery

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.

Secondary outcomes

Incidence of percutaneous CSF leakage / pseudomeningocele/ hydrocephalus/meningitis

Time frame: Up to 90 days after surgery

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

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Feb 8, 2023
Registry last updated: Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed