Intraventricular NeoplasmNCT05717335
Observational Pilot Study With TachoSil as a Ventricular Sealant
An observational study of Intraventricular Neoplasm, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraventricular Neoplasm
- What is being tested?
- TachoSil
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2022to 3 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients or representatives who do not want to sign the consent are excluded informed, pregnant women or those under 18 years of age.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
About this study
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).
Read the detailed description
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).
Primary objectives:
The main objective of the study is to evaluate the effectiveness and safety of TachoSil in patients who require ventricular entry.
To 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.
Secondary objectives
- Intraoperative incidence of fistula after application of the ventricular patch at 20cm PEEP H20 (efficacy objective).
- Incidence of clinically confirmed percutaneous fistula during the first 30 days after surgery (efficacy objective).
- Incidence of pseudomeningocele >20cc confirmed with MRI or ultrasound (effectiveness objective).
- Incidence of radiologically confirmed hydrocephalus during the first 90 days after of the surgery.
- Record the percentage of use of other dural sealants
- Evaluate the cost effectiveness of the product.
- Describe the adverse effects related to the product
- Incidence of complication requiring reintervention within 30 days to the main surgery (safety objective).
- Assessment of the complications that are avoided: readmissions.
Study period: from December 2020 to December 2023.
- Conditions
- Intraventricular Neoplasm
- Being tested
- TachoSil
- Keywords
- Ventricle opening, ventricular entry, Complication, Pseudomeningocele, Cerebrospinal fluid leakage, Meningitis
- Medical subject headings
- Cerebral Ventricle Neoplasms, Cerebrospinal Fluid Leak, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TachoSilDrug
Also called TachoSil is a sponge sealant patch that is coated with the active substances human fibrinogen and human thrombin.
Placement of TachoSil over the ventricular entry point in patients with periventricular lesions in order to avoid complications related to the ventricular entry.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TachoSil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 90 days after surgery
Secondary outcomes (1)
Incidence of percutaneous CSF leakage / pseudomeningocele/ hydrocephalus/meningitis
Percentage of complications with percutaneous CSF leakage pseudomeningocele/ hydrocephalus/meningitis
Measured: Up to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 May 2022
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Intraventricular NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pilar Teixidor Rodriguez, MD, PhD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717335
- Sponsor's protocol ID
- Tachosil-vent-2022
- Other IDs
- PI-22-078
- Status last verified
- Feb 2023
- First submitted
- 10 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28655201Eser 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.
PubMed 30907976Farber 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.
PubMed 30026145Grotenhuis 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.
PubMed 16293457Altaf 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.
PubMed 28083041Behling 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.
PubMed 28729143Coucke 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.
PubMed 34499261Danish 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.
PubMed 16509475Fang 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.
PubMed 28751035Hussein 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.
PubMed 28529027John 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.
PubMed 27813467Mistry 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.
PubMed 31058968Slot 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.
PubMed 33538867Tu 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.
PubMed 25296539van 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.
PubMed 34916315
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Pilot Study With TachoSil as a Ventricular Sealant
- ClinicalTrials.gov ID
- NCT05717335
- Acronym / sponsor ID
- Tachosil-vent-2022
- Conditions
- Intraventricular Neoplasm
- Keywords
- Ventricle opening, ventricular entry, Complication, Pseudomeningocele, Cerebrospinal fluid leakage, Meningitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Primary objectives:
The main objective of the study is to evaluate the effectiveness and safety of TachoSil in patients who require ventricular entry.
To 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.
Secondary objectives
- Intraoperative incidence of fistula after application of the ventricular patch at 20cm PEEP H20 (efficacy objective).
- Incidence of clinically confirmed percutaneous fistula during the first 30 days after surgery (efficacy objective).
- Incidence of pseudomeningocele >20cc confirmed with MRI or ultrasound (effectiveness objective).
- Incidence of radiologically confirmed hydrocephalus during the first 90 days after of the surgery.
- Record the percentage of use of other dural sealants
- Evaluate the cost effectiveness of the product.
- Describe the adverse effects related to the product
- Incidence of complication requiring reintervention within 30 days to the main surgery (safety objective).
- Assessment of the complications that are avoided: readmissions.
Study period: from December 2020 to December 2023.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ventricular entry during surgery (vascular, tumoral and epilepsy). | – | Drug: TachoSilGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients or representatives who do not want to sign the consent are excluded informed, pregnant women or those under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TachoSilAlso: TachoSil is a sponge sealant patch that is coated with the active substances human fibrinogen and human thrombin.Placement of TachoSil over the ventricular entry point in patients with periventricular lesions in order to avoid complications related to the ventricular entry. | Drug | Patients with ventricular entry during surgery (vascular, tumoral and epilepsy). |
Primary outcome
The main objective of the study is to evaluate the effectiveness and safety of TachoSil in operated patients who require opening of the ventricle.
Time frame: Up to 90 days after surgery
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.
1 secondary outcome
Incidence of percutaneous CSF leakage / pseudomeningocele/ hydrocephalus/meningitis
Time frame: Up to 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 28655201Dasenbrock 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.
- Background: PubMed 30907976Eser 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.
- Background: PubMed 30026145Farber 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.
- Background: PubMed 16293457Grotenhuis 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.
- Results publication: PubMed 28083041Altaf 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.
- Results publication: PubMed 28729143Behling 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.
- Results publication: PubMed 34499261Coucke 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.
- Results publication: PubMed 16509475Danish 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.
- Results publication: PubMed 28751035Fang 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.
- Results publication: PubMed 28529027Hussein 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.
- Results publication: PubMed 27813467John 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.
- Results publication: PubMed 31058968Mistry 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilar Teixidor Rodriguez, MD, PhD principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraventricular Neoplasm, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Up to 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05717335, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.