Effectiveness and Safety of TachoSil® Fibrin Sealant Patch for Supporting Dural Sealing Among Adult Inpatients
Effectiveness and Safety of TachoSil® Fibrin Sealant Patch in Comparison to a Hydrogel Sealant for Supporting Dural Sealing Among Adult Inpatients in the United States: A Retrospective, Non-Inferiority, Cohort Study
This retrospective observational cohort study compares the effectiveness and safety of adjunctive TachoSil® fibrin sealant patch with DuraSeal® hydrogel sealant for supporting dural sealing in adult patients undergoing cranial or spinal surgery at participating United States hospitals. Medical records will be reviewed to assess clinically evident cerebrospinal fluid leak or clinically evident pseudomeningocele within 90 days after surgery. The study will use 1:1 propensity score matching to evaluate whether TachoSil® is non-inferior to DuraSeal® and will assess additional effectiveness and safety outcomes.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Michele Young
- Número de teléfono: 1 689-316-8809
- Correo electrónico: Michele.young@corza.com
Copia de seguridad de contactos de estudio
- Nombre: Jeff Wilson
- Número de teléfono: 416-578-9058
- Correo electrónico: Jeff.Wilson@corza.com
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Reclutamiento
- Johns Hopkins University
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Investigador principal:
- Daniel Lubelski, MD
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New York
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New York, New York, Estados Unidos, 10032
- Reclutamiento
- Columbia University
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Investigador principal:
- Raymond F. Sekula, MD
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45221
- Reclutamiento
- University of Cincinnati College of Medicine
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Investigador principal:
- Norberto Andaluz, MD, MBA, MHA, FACS
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Reclutamiento
- Thomas Jefferson University
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Investigador principal:
- James S. Harrop, MD, MSHQS, FACS
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Pittsburgh, Pennsylvania, Estados Unidos, 15212
- Reclutamiento
- Alleghany Health Network
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Investigador principal:
- Alexander Yu, MD
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Washington
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Seattle, Washington, Estados Unidos, 98122
- Reclutamiento
- Swedish Health Services
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Investigador principal:
- Zachary N. Litvack, MD MBA FAANS FACS
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
All adult patients who were admitted to one of the target hospitals for a neurological surgery and discharged from January 1, 2017, to March 31, 2026 (index period) and had use of TachoSil® or DuraSeal® sealants during the neurological surgery (index surgery) as dural sealant and met the study selection criteria will be included in this study.
Descripción
Inclusion Criteria:
- Aged ≥ 18 years
- Had an inpatient encounter to select sites with a cranial or spinal neurological surgery that involves dural sealing performed and discharged during January 1, 2017, and March 31, 2026
- Had use of TachoSil® or DuraSeal® sealants during the cranial or spinal neurological surgery as supportive dural sealing method
Note: Any surgery meeting the above criteria is considered index surgery
Exclusion Criteria:
- Index surgery was trauma-related
- Had an infection within 7 days prior to index date
- Had any neurosurgery involving dural opening during the 12-month look-back period
- Had neoplasm of dura mater/meningioma, requiring resection of dura during index visit (the earliest visit meeting selection criteria) or 12-month look-back period
- Was pregnant at index visit
- Had a CSF leak during the 12-month look-back period
- If the surgical approach was transbasal or transpetrosal, if the arachnoid membrane and CSF- containing system remained intact, or if there was >1 dura opening (excluding extra ventricular or lumbar drains) during index surgery
- Had use of Evarrest patch, Tisseel, Adherus, CraniSeal, Duragen, fibrin glue or other dural sealing products during index surgery
- Had radiation therapy to surgical field in the 3 months prior to index date
- Had chronic corticosteroid use in the 3 months prior to index date
- Had both TachoSil® and DuraSeal® used for dural closure during index neurological surgery
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: RETROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
TachoSil®
Adult inpatients who underwent neurological surgery with the use of TachoSil® for dural sealing support and were discharged from US hospitals from 01 January 2017 through 31 March 2026 |
TachoSil® is an absorbable fibrin sealant patch consisting of equine collagen coated with human fibrinogen and thrombin. |
|
DuraSeal®
Adult inpatients who underwent neurological surgery with the use of DuraSeal® for dural sealing support and were discharged from US hospitals from 01 January 2017 through 31 March 2026 |
DuraSeal® sealants are polyethylene glycol (PEG) based hydrogel. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Risk of Clinically Evident CSF Leak or Clinically Evident Pseudomeningocele
Periodo de tiempo: Within 90 days post surgery
|
A clinically evident CSF leak is defined as clear fluid leaking through the surgical incision or orifice verified by a glucose concentration test or β-2 transferrin test. A clinically evident pseudomeningocele is defined as a subcutaneous visible and/or palpable fluid accumulation adjacent to or at the site of surgical incision suspected to be CSF. If there is not a collection of CSF/pseudomeningocele, or active leak that can be sampled for β-2 transferrin test, but the participant had symptoms consistent with intracranial hypotension and/or an ex vacuo type subdural hematoma, the participant will be considered as having clinically evident CSF leak or pseudomeningocele. |
Within 90 days post surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Risk of Non-clinically Evident Pseudomeningocele Without Occurrence of the Primary Endpoint
Periodo de tiempo: Within 90 days post surgery
|
Non-clinically evident pseudomeningocele is defined as CSF accumulation detected only by computed tomography (CT) or magnetic resonance imaging (MRI) scan. |
Within 90 days post surgery
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious AEs (SAEs)
Periodo de tiempo: Within 90 days post surgery
|
AEs refer to any undesirable event that is documented in a site's Electronic Medical Records (EMR) for an eligible participant as occurring within 90 days of the index surgery regardless of whether or not the events were considered causally related to TachoSil® or DuraSeal® use. SAEs refer to any AE documented in a site's EMR for an eligible patient that results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Individual prespecified AEs and the composite categories of any expected AE and any unexpected AE will be summarized by treatment cohort. |
Within 90 days post surgery
|
|
Risk of Clinically Evident CSF Leak
Periodo de tiempo: Within 90 days post surgery
|
A clinically evident CSF leak is defined as clear fluid leaking through the surgical incision or orifice verified by a glucose concentration test or β-2 transferrin test. |
Within 90 days post surgery
|
|
Risk of Clinically Evident Pseudomeningocele
Periodo de tiempo: Within 90 days post surgery
|
A clinically evident pseudomeningocele is defined as a subcutaneous visible and/or palpable fluid accumulation adjacent to or at the site of surgical incision suspected to be CSF. |
Within 90 days post surgery
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ning Rosenthal, MD, PhD, MPH,, Premier Inc
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BL125351
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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