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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Michele Young
- Numer telefonu: 1 689-316-8809
- E-mail: Michele.young@corza.com
Kopia zapasowa kontaktu do badania
- Nazwa: Jeff Wilson
- Numer telefonu: 416-578-9058
- E-mail: Jeff.Wilson@corza.com
Lokalizacje studiów
-
-
Maryland
-
Baltimore, Maryland, Stany Zjednoczone, 21287
- Rekrutacyjny
- Johns Hopkins University
-
Główny śledczy:
- Daniel Lubelski, MD
-
-
New York
-
New York, New York, Stany Zjednoczone, 10032
- Rekrutacyjny
- Columbia University
-
Główny śledczy:
- Raymond F. Sekula, MD
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Ohio
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Cincinnati, Ohio, Stany Zjednoczone, 45221
- Rekrutacyjny
- University of Cincinnati College of Medicine
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Główny śledczy:
- Norberto Andaluz, MD, MBA, MHA, FACS
-
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Pennsylvania
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 19107
- Rekrutacyjny
- Thomas Jefferson University
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Główny śledczy:
- James S. Harrop, MD, MSHQS, FACS
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15212
- Rekrutacyjny
- Alleghany Health Network
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Główny śledczy:
- Alexander Yu, MD
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Washington
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Seattle, Washington, Stany Zjednoczone, 98122
- Rekrutacyjny
- Swedish Health Services
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Główny śledczy:
- Zachary N. Litvack, MD MBA FAANS FACS
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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.
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: RETROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Risk of Clinically Evident CSF Leak or Clinically Evident Pseudomeningocele
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Risk of Non-clinically Evident Pseudomeningocele Without Occurrence of the Primary Endpoint
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Ning Rosenthal, MD, PhD, MPH,, Premier Inc
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- BL125351
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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