Clinical trial · Observational
Observational Pilot Study With TachoSil as a Ventricular Sealant
NCT05717335CI-TRIAL-00063731completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraventricular Neoplasm | Intraventricular Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TachoSil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with ventricular entry during surgery (vascular, tumoral and epilepsy).
- description
- Group of patients operated on for periventricular lesions with ventricular entry and placement of TachoSil directly over the area of ventricular opening in order to avoid complications.
- interventionNames
- Drug: TachoSil
Primary outcomes (1)
- measure
- 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
- description
- To evaluate the effectiveness and the percentage of complications related to the ventricular entry during surgery. Taking into account hydrocephalus, CSF leak, meningitis and pseudomeningocele.
Secondary outcomes (1)
- measure
- Incidence of percutaneous CSF leakage / pseudomeningocele/ hydrocephalus/meningitis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (17)
- BACKGROUNDDasenbrock HH, Yan SC, Chavakula V, Gormley WB, Smith TR, Claus EB, Dunn IF. Unplanned Reoperation After Craniotomy for Tumor: A National Surgical Quality Improvement Program Analysis. Neurosurgery. 2017 Nov 1;81(5):761-771. doi: 10.1093/neuros/nyx089. PMID 28655201
- BACKGROUNDEser MT, Hanalioglu S, Cetiner MZ, Dinc S, Peker HO, Sorar M, Dolgun H, Turkoglu E. Identification of Risk Factors for Postoperative Cerebrospinal Fluid Leakage and Comparison of Two Alternative Dural Augmentation Techniques in Posterior Fossa and Spinal Surgeries. Turk Neurosurg. 2019;29(3):377-385. doi: 10.5137/1019-5149.JTN.24432-18.0. PMID 30907976
- BACKGROUNDFarber H, McDowell MM, Alhourani A, Agarwal N, Friedlander RM. Duraplasty Type as a Predictor of Meningitis and Shunting After Chiari I Decompression. World Neurosurg. 2018 Oct;118:e778-e783. doi: 10.1016/j.wneu.2018.07.050. Epub 2018 Jul 17. PMID 30026145
- BACKGROUNDGrotenhuis JA. Costs of postoperative cerebrospinal fluid leakage: 1-year, retrospective analysis of 412 consecutive nontrauma cases. Surg Neurol. 2005 Dec;64(6):490-3, discussion 493-4. doi: 10.1016/j.surneu.2005.03.041. PMID 16293457
- RESULTAltaf I, Vohra AH, Shams S. Management of Cerebrospinal Fluid Leak following Posterior Cranial Fossa Surgery. Pak J Med Sci. 2016 Nov-Dec;32(6):1439-1443. doi: 10.12669/pjms.326.9956. PMID 28083041
- RESULTBehling F, Kaltenstadler M, Noell S, Schittenhelm J, Bender B, Eckert F, Tabatabai G, Tatagiba M, Skardelly M. The Prognostic Impact of Ventricular Opening in Glioblastoma Surgery: A Retrospective Single Center Analysis. World Neurosurg. 2017 Oct;106:615-624. doi: 10.1016/j.wneu.2017.07.034. Epub 2017 Jul 18. PMID 28729143
- RESULTCoucke B, Van Gerven L, De Vleeschouwer S, Van Calenbergh F, van Loon J, Theys T. The incidence of postoperative cerebrospinal fluid leakage after elective cranial surgery: a systematic review. Neurosurg Rev. 2022 Jun;45(3):1827-1845. doi: 10.1007/s10143-021-01641-y. Epub 2021 Sep 9.