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Clinical trial

Observational Pilot Study With TachoSil as a Ventricular Sealant

ID
Name
Tachosil-vent-2022
Description
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).
Trial arms
Trial start
2022-05-01
Estimated PCD
2023-02-03
Trial end
2023-02-03
Status
Completed
Treatment
TachoSil
Placement of TachoSil over the ventricular entry point in patients with periventricular lesions in order to avoid complications related to the ventricular entry.
Arms:
Patients with ventricular entry during surgery (vascular, tumoral and epilepsy).
Other names:
TachoSil is a sponge sealant patch that is coated with the active substances human fibrinogen and human thrombin.
Size
20
Primary endpoint
The main objective of the study is to evaluate the effectiveness and safety of TachoSil in operated patients who require opening of the ventricle.
Up to 90 days after surgery
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 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2023-02-08

1 organization

1 product

1 indication

Organization
Germans Trias i Pujol Hospital
Product
TachoSil
Indication
Intraventricular Neoplasm