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 range18 Years

SexALL

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.

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