Effectiveness and Safety of TachoSil® Fibrin Sealant Patch for Supporting Dural Sealing Among Adult Inpatients
Cerebrospinal Fluid (CSF) Leak · Psuedomeningocele
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 600 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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
Población del 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.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
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
Drug: TachoSil®
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
Device: DuraSeal®
TachoSil® DRUG
TachoSil® is an absorbable fibrin sealant patch consisting of equine collagen coated with human fibrinogen and thrombin.
DuraSeal® DEVICE
DuraSeal® sealants are polyethylene glycol (PEG) based hydrogel.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Risk of Clinically Evident CSF Leak or Clinically Evident Pseudomeningocele
Plazo: 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.
Medidas secundarias
Risk of Non-clinically Evident Pseudomeningocele Without Occurrence of the Primary Endpoint
Plazo: 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.
Number of Participants Experiencing Adverse Events (AEs) and Serious AEs (SAEs)
Plazo: 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.
Risk of Clinically Evident CSF Leak
Plazo: 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.
Risk of Clinically Evident Pseudomeningocele
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (6)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
6 centros
Johns Hopkins UniversityBaltimore, Maryland, United StatesReclutando
Columbia UniversityNew York, New York, United StatesReclutando
University of Cincinnati College of MedicineCincinnati, Ohio, United StatesReclutando
Thomas Jefferson UniversityPhiladelphia, Pennsylvania, United StatesReclutando
Alleghany Health NetworkPittsburgh, Pennsylvania, United StatesReclutando
Swedish Health ServicesSeattle, Washington, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- Corza Medical GmbH
- Inicio del estudio
- 13 feb 2026 Real
- Finalización primaria
- 16 nov 2026 Estimado
- Finalización del estudio
- 16 nov 2026 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
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
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026