Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 2:52 AM
Study NCT ID:
NCT05717335
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2023-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Pilot Study With TachoSil as a Ventricular Sealant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002551', 'term': 'Cerebral Ventricle Neoplasms'}, {'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}, {'id': 'D008581', 'term': 'Meningitis'}], 'ancestors': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C518955', 'term': 'TachoSil'}, {'id': 'D013917', 'term': 'Thrombin'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'measure': 'Incidence of percutaneous CSF leakage / pseudomeningocele/ hydrocephalus/meningitis', 'timeFrame': 'Up to 90 days after surgery', 'description': 'Percentage of complications with percutaneous CSF leakage pseudomeningocele/ hydrocephalus/meningitis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ventricle opening', 'ventricular entry', 'Complication', 'Pseudomeningocele', 'Cerebrospinal fluid leakage', 'Meningitis'], 'conditions': ['Intraventricular Neoplasm']}, 'referencesModule': {'references': [{'pmid': '28655201', 'type': 'BACKGROUND', 'citation': 'Dasenbrock 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': '30907976', 'type': 'BACKGROUND', 'citation': 'Eser 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': '30026145', 'type': 'BACKGROUND', 'citation': 'Farber 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': '16293457', 'type': 'BACKGROUND', 'citation': 'Grotenhuis 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': '28083041', 'type': 'RESULT', 'citation': 'Altaf 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': '28729143', 'type': 'RESULT', 'citation': 'Behling 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': '34499261', 'type': 'RESULT', 'citation': 'Coucke 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.'}, {'pmid': '16509475', 'type': 'RESULT', 'citation': 'Danish SF, Samdani A, Hanna A, Storm P, Sutton L. Experience with acellular human dura and bovine collagen matrix for duraplasty after posterior fossa decompression for Chiari malformations. J Neurosurg. 2006 Jan;104(1 Suppl):16-20. doi: 10.3171/ped.2006.104.1.16.'}, {'pmid': '28751035', 'type': 'RESULT', 'citation': 'Fang C, Zhu T, Zhang P, Xia L, Sun C. Risk factors of neurosurgical site infection after craniotomy: A systematic review and meta-analysis. Am J Infect Control. 2017 Nov 1;45(11):e123-e134. doi: 10.1016/j.ajic.2017.06.009. Epub 2017 Jul 24.'}, {'pmid': '28529027', 'type': 'RESULT', 'citation': 'Hussein K, Bitterman R, Shofty B, Paul M, Neuberger A. Management of post-neurosurgical meningitis: narrative review. Clin Microbiol Infect. 2017 Sep;23(9):621-628. doi: 10.1016/j.cmi.2017.05.013. Epub 2017 May 18.'}, {'pmid': '27813467', 'type': 'RESULT', 'citation': 'John JK, Robin AM, Pabaney AH, Rammo RA, Schultz LR, Sadry NS, Lee IY. Complications of ventricular entry during craniotomy for brain tumor resection. J Neurosurg. 2017 Aug;127(2):426-432. doi: 10.3171/2016.7.JNS16340. Epub 2016 Nov 4.'}, {'pmid': '31058968', 'type': 'RESULT', 'citation': 'Mistry AM, Kelly PD, Gallant JN, Mummareddy N, Mobley BC, Thompson RC, Chambless LB. Comparative Analysis of Subventricular Zone Glioblastoma Contact and Ventricular Entry During Resection in Predicting Dissemination, Hydrocephalus, and Survival. Neurosurgery. 2019 Nov 1;85(5):E924-E932. doi: 10.1093/neuros/nyz144.'}, {'pmid': '33538867', 'type': 'RESULT', 'citation': 'Slot EMH, van Baarsen KM, Hoving EW, Zuithoff NPA, van Doormaal TPC. Cerebrospinal fluid leakage after cranial surgery in the pediatric population-a systematic review and meta-analysis. Childs Nerv Syst. 2021 May;37(5):1439-1447. doi: 10.1007/s00381-021-05036-8. Epub 2021 Feb 4.'}, {'pmid': '25296539', 'type': 'RESULT', 'citation': 'Tu A, Tamburrini G, Steinbok P. Management of postoperative pseudomeningoceles: an international survey study. Childs Nerv Syst. 2014 Nov;30(11):1791-801. doi: 10.1007/s00381-014-2501-9. Epub 2014 Oct 9.'}, {'pmid': '34916315', 'type': 'RESULT', 'citation': 'van Lieshout C, Slot EMH, Kinaci A, Kollen MH, Hoving EW, Frederix GWJ, van Doormaal TPC. Cerebrospinal fluid leakage costs after craniotomy and health economic assessment of incidence reduction from a hospital perspective in the Netherlands. BMJ Open. 2021 Dec 16;11(12):e052553. doi: 10.1136/bmjopen-2021-052553.'}, {'pmid': '29232819', 'type': 'RESULT', 'citation': 'Weng J, Wu H, Wang Z. Letter to the Editor Regarding "The Prognostic Impact of Ventricular Opening in Glioblastoma Surgery: A Retrospective Single Center Analysis". World Neurosurg. 2018 Jan;109:512. doi: 10.1016/j.wneu.2017.10.067. No abstract available.'}, {'pmid': '39331127', 'type': 'DERIVED', 'citation': 'Teixidor-Rodriguez P, Brugada-Bellsola F, Menendez-Giron S, Tardaguila-Serrano M, Gonzalez-Crespo A, Nunez-Marin F, Montane E, Busquets-Bonet J, Munoz-Narbona L, Dominguez-Alonso CJ. Effectiveness and safety of Tachosil(R) as a ventricular sealant: an observational cohort study. Acta Neurochir (Wien). 2024 Sep 27;166(1):384. doi: 10.1007/s00701-024-06276-8.'}]}, 'descriptionModule': {'briefSummary': 'The working hypothesis in this study is that after entering the cerebral ventricular system the sealing with TachoSil is effective and safe.\n\nA 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).', 'detailedDescription': 'Pilot observational study with medications (MOE), single-center, prospective and retrospective study with a group of patients operated on for periventricular lesions and with ventricular entry. As it is an infrequent type of surgery in our centre, the study includes a retrospective group (same surgery and use of TachoSil).\n\nPrimary objectives:\n\nThe main objective of the study is to evaluate the effectiveness and safety of TachoSil in patients who require ventricular entry.\n\nTo evaluate the effectiveness, the percentage of complications related to the ventricular entry during surgery are recorded. These complications are hydrocephalus, CSF leak, meningitis, and pseudomeningocele.\n\nSecondary objectives\n\n* Intraoperative incidence of fistula after application of the ventricular patch at 20cm PEEP H20 (efficacy objective).\n* Incidence of clinically confirmed percutaneous fistula during the first 30 days after surgery (efficacy objective).\n* Incidence of pseudomeningocele \\>20cc confirmed with MRI or ultrasound (effectiveness objective).\n* Incidence of radiologically confirmed hydrocephalus during the first 90 days after of the surgery.\n* Record the percentage of use of other dural sealants\n* Evaluate the cost effectiveness of the product.\n* Describe the adverse effects related to the product\n* Incidence of complication requiring reintervention within 30 days to the main surgery (safety objective).\n* Assessment of the complications that are avoided: readmissions.\n\nStudy period: from December 2020 to December 2023.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective supratentorial craniotomy due to periventricular lesions (tumoral, vascular or epilepsy) with ventricular entry during the procedure. The TachoSil patch is used as a ventricular sealant. A part of the population will be collected prospectively and retrospective cases operated using the same systematic will also be collected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Ventricular entry during the procedure (intraoperative CSF outflow from the ventricle noticed by the surgeon)\n* Adults over the age of 18\n* 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.\n\nExclusion Criteria:\n\n* Patients or representatives who do not want to sign the consent are excluded informed, pregnant women or those under 18 years of age.'}, 'identificationModule': {'nctId': 'NCT05717335', 'briefTitle': 'Observational Pilot Study With TachoSil as a Ventricular Sealant', 'organization': {'class': 'OTHER', 'fullName': 'Germans Trias i Pujol Hospital'}, 'officialTitle': 'Observational Pilot Study With TachoSil as a Ventricular Sealant', 'orgStudyIdInfo': {'id': 'Tachosil-vent-2022'}, 'secondaryIdInfos': [{'id': 'PI-22-078', 'type': 'REGISTRY', 'domain': 'Ethics committee reference'}]}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'TachoSil', 'type': 'DRUG', 'otherNames': ['TachoSil is a sponge sealant patch that is coated with the active substances human fibrinogen and human thrombin.'], 'description': 'Placement of TachoSil over the ventricular entry point in patients with periventricular lesions in order to avoid complications related to the ventricular entry.', 'armGroupLabels': ['Patients with ventricular entry during surgery (vascular, tumoral and epilepsy).']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}], 'overallOfficials': [{'name': 'Pilar Teixidor Rodriguez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Germans Trias i Pujol Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}