CompletedNot Applicable

Observational Pilot Study With TachoSil as a Ventricular Sealant

Spain20 participantsStarted 2022-05-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT05717335

SponsorGermans Trias i Pujol Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-02-03

View on ClinicalTrials.gov More Intraventricular Neoplasm trials