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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Michele Young
- Telefoonnummer: 1 689-316-8809
- E-mail: Michele.young@corza.com
Studie Contact Back-up
- Naam: Jeff Wilson
- Telefoonnummer: 416-578-9058
- E-mail: Jeff.Wilson@corza.com
Studie Locaties
-
-
Maryland
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Baltimore, Maryland, Verenigde Staten, 21287
- Werving
- Johns Hopkins University
-
Hoofdonderzoeker:
- Daniel Lubelski, MD
-
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New York
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New York, New York, Verenigde Staten, 10032
- Werving
- Columbia University
-
Hoofdonderzoeker:
- Raymond F. Sekula, MD
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45221
- Werving
- University of Cincinnati College of Medicine
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Hoofdonderzoeker:
- Norberto Andaluz, MD, MBA, MHA, FACS
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Werving
- Thomas Jefferson University
-
Hoofdonderzoeker:
- James S. Harrop, MD, MSHQS, FACS
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Pittsburgh, Pennsylvania, Verenigde Staten, 15212
- Werving
- Alleghany Health Network
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Hoofdonderzoeker:
- Alexander Yu, MD
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Washington
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Seattle, Washington, Verenigde Staten, 98122
- Werving
- Swedish Health Services
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Hoofdonderzoeker:
- Zachary N. Litvack, MD MBA FAANS FACS
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: RETROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Risk of Clinically Evident CSF Leak or Clinically Evident Pseudomeningocele
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Risk of Non-clinically Evident Pseudomeningocele Without Occurrence of the Primary Endpoint
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ning Rosenthal, MD, PhD, MPH,, Premier Inc
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BL125351
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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