Observational Pilot Study With TachoSil as a Ventricular Sealant

February 3, 2023 updated by: Germans Trias i Pujol Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias I Pujol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Placement of TachoSil over the ventricular entry point in patients with periventricular lesions in order to avoid complications related to the ventricular entry.
Other Names:
  • TachoSil is a sponge sealant patch that is coated with the active substances human fibrinogen and human thrombin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of percutaneous CSF leakage / pseudomeningocele/ hydrocephalus/meningitis
Time Frame: Up to 90 days after surgery
Percentage of complications with percutaneous CSF leakage pseudomeningocele/ hydrocephalus/meningitis
Up to 90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Investigators

  • Principal Investigator: Pilar Teixidor Rodriguez, MD, PhD, Germans Trias i Pujol Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2022

Primary Completion (ACTUAL)

February 3, 2023

Study Completion (ACTUAL)

February 3, 2023

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tachosil-vent-2022
  • PI-22-078 (REGISTRY: Ethics committee reference)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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