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Completed
NCT05717335
Observational Pilot Study With TachoSil as a Ventricular Sealant
Conditions: Intraventricular Neoplasm
Sex: All
Ages: 18 Years – N/A
Enrollment: 20
Sponsor: Germans Trias i Pujol Hospital
Location: Spain
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).
Eligibility Criteria
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 TachoSilVentricular entry during the procedure (intraoperative CSF outflow from the ventricle noticed by the surgeon)Adults over the age of 18Informed 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.
Source: ClinicalTrials.gov (NCT05717335). StuddyBuddy aggregates publicly available trial information.
