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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Michele Young
- 전화번호: 1 689-316-8809
- 이메일: Michele.young@corza.com
연구 연락처 백업
- 이름: Jeff Wilson
- 전화번호: 416-578-9058
- 이메일: Jeff.Wilson@corza.com
연구 장소
-
-
Maryland
-
Baltimore, Maryland, 미국, 21287
- 모병
- Johns Hopkins University
-
수석 연구원:
- Daniel Lubelski, MD
-
-
New York
-
New York, New York, 미국, 10032
- 모병
- Columbia University
-
수석 연구원:
- Raymond F. Sekula, MD
-
-
Ohio
-
Cincinnati, Ohio, 미국, 45221
- 모병
- University of Cincinnati College of Medicine
-
수석 연구원:
- Norberto Andaluz, MD, MBA, MHA, FACS
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19107
- 모병
- Thomas Jefferson University
-
수석 연구원:
- James S. Harrop, MD, MSHQS, FACS
-
Pittsburgh, Pennsylvania, 미국, 15212
- 모병
- Alleghany Health Network
-
수석 연구원:
- Alexander Yu, MD
-
-
Washington
-
Seattle, Washington, 미국, 98122
- 모병
- Swedish Health Services
-
수석 연구원:
- Zachary N. Litvack, MD MBA FAANS FACS
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: RETROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Risk of Clinically Evident CSF Leak or Clinically Evident Pseudomeningocele
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Risk of Non-clinically Evident Pseudomeningocele Without Occurrence of the Primary Endpoint
기간: 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)
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Ning Rosenthal, MD, PhD, MPH,, Premier Inc
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- BL125351
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .