Observational Pilot Study With TachoSil as a Ventricular Sealant

NCT05717335 | Completed DMC FDA Drug

• 2 other identifiers: Tachosil-vent-2022PI-22-078
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Intraventricular Neoplasm

Keywords

Ventricle opening; ventricular entry; Complication; Pseudomeningocele; Cerebrospinal fluid leakage; Meningitis

Outcome Measures

Primary Outcomes (1)

• The main objective of the study is to evaluate the effectiveness and safety of TachoSil in operated patients who require opening of the ventricle.

  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.

  Up to 90 days after surgery

Secondary Outcomes (1)

• Incidence of percutaneous CSF leakage / pseudomeningocele/ hydrocephalus/meningitis

  Up to 90 days after surgery

Study Arms (1)

Patients with ventricular entry during surgery (vascular, tumoral and epilepsy).

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.

Drug: TachoSil

Interventions

TachoSil DRUG

Placement of TachoSil over the ventricular entry point in patients with periventricular lesions in order to avoid complications related to the ventricular entry.

Also known as: TachoSil is a sponge sealant patch that is coated with the active substances human fibrinogen and human thrombin.

Patients with ventricular entry during surgery (vascular, tumoral and epilepsy).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients or representatives who do not want to sign the consent are excluded informed, pregnant women or those under 18 years of age.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Related Publications (17)

• 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: 28655201 BACKGROUND

• 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: 30907976 BACKGROUND

• 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: 30026145 BACKGROUND

• 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: 16293457 BACKGROUND

• 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: 28083041 RESULT

• 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: 28729143 RESULT

• 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: 34499261 RESULT

• 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: 16509475 RESULT

• 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: 28751035 RESULT

• 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: 28529027 RESULT

• 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: 27813467 RESULT

• 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: 31058968 RESULT

• 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: 33538867 RESULT

• 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: 25296539 RESULT

• 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: 34916315 RESULT

• 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: 29232819 RESULT

• 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.

  PMID: 39331127 DERIVED

MeSH Terms

Conditions

Cerebral Ventricle Neoplasms; Cerebrospinal Fluid Leak; Meningitis

Interventions

TachoSil; Thrombin

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Pilar Teixidor Rodriguez, MD, PhD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 8, 2023
• Study Start: May 1, 2022
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

ES (1)