Observational studyActa neurochirurgica2024
Effectiveness and safety of Tachosil® as a ventricular sealant: an observational cohort study.
Observational study in Acta neurochirurgica, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05717335 (Observational Pilot Study With TachoSil as a Ventricular Sealant), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Observational Pilot Study With TachoSil as a Ventricular Sealant
Who cites it
2 citing papers in PubMed.
- TachoSilNeurosurgical review · 2026Article
- Could TachoSil application in cardiac surgery be potentially dangerous? A review of the literature.Kardiochirurgia i torakochirurgia polska = Polish journal of cardio-thoracic surgery · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeSurgery close to or in contact with the ventricular system is challenging due to the complications. We sought to evaluate the effectiveness and safety of TachoSil® as a ventricular sealant in preventing complications after cranial surgery with an open ventricular system (OVS).
methodsThis is a single-center and prospective cohort study We included patients who underwent elective surgery for supratentorial craniotomy and periventricular pathology between December 2020 and November 2023. We registered surgical complications arising from CSF dynamics (such as percutaneous cerebrospinal fluid (CSF) leakage, hydrocephalus, pseudomeningocele), infections, and other complications (postsurgical hematoma) adverse drug reactions (ADRs), reintervention or hospital readmission up to 90 days after surgery.
resultsForty interventions were performed on 39 patients, whose median age was 56 years. Eleven patients (28.2%) had antecedents of previous surgery in the same location, 5 (12.8%) had previously received radiotherapy and chemotherapy, and 11 (28.2%) were smokers. Twenty-four patients (60%) underwent surgery for high-grade glioma, 8 (20%) for low-grade gliomas, 6 (15%) for metastasis and 2 (5%) for meningioma. Throughout the study and up to 90 days after surgery, none of the patients presented an ADR. Only 2 patients (5%) presented with a surgery complications derived from ventricular opening (one patient with a percutaneous CSF leakage and one patients with external hydrocephalus). Both patients resolved with a ventriculoperitoneal shunt.
conclusionsTachoSil® is a dural sealant that can be used safely and effectively intraparenchymally in patients whose surgery involves a ventricular opening. Only 5% of treated patients presented complications arising from CSF hydrodynamics. No patients had pseudomeningocele, infections or complications related to the use of this sealant. To confirm these positive results, randomized and comparative clinical trials assessing the efficacy of TachoSil® in patients after cranial surgery with an OVS are essential. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: This study was registered in the Clinical Trials.gov (NCT05717335). Date May 1
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Registered trials
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