Fibrin Sealant (Human) (Omrix)(Fibrin Sealant (Human) (Omrix)) - 在研适应症：出血_专利_临床

概要

基本信息

药物类型

非重组凝血因子

别名

Fibrin Sealant Patch、Crosseal、Evarrest

+ [1]

靶点-

作用方式-

作用机制-

治疗领域

其他疾病

在研适应症

出血

非在研适应症

凝血障碍心血管疾病脑出血+ [6]

原研机构

Omrix Biopharmaceuticals Ltd.

在研机构

Ethicon, Inc.

非在研机构

Omrix Biopharmaceuticals NV

Omrix Biopharmaceuticals Ltd.

最高研发阶段批准上市

首次获批日期

美国 (2003-03-21),

出血

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 9681008

Sequence Code 1216176

关联

24

项与 Fibrin Sealant (Human) (Omrix) 相关的临床试验

EUCTR2019-004657-89-GB

/ Unknown status临床3期

A Prospective Study Evaluating the Safety and Effectiveness of EVARREST® Fibrin Sealant Patch in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open, Abdominal, Retroperitoneal, Pelvic and Thoracic (non-cardiac) Surgery in Pediatric Patients

开始日期2020-12-14

申办/合作机构-

NCT03255174

/ Recruiting临床3期

A Prospective Study Evaluating the Safety and Effectiveness of EVARREST® Fibrin Sealant Patch in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (Non-cardiac) Surgery in Pediatric Patients

The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric population.

开始日期2018-03-20

申办/合作机构

Ethicon, Inc.

NCT02553122

/ Withdrawn临床3期IIT

The Combined Efficacy of Evicel and Tranexamic Acid on Total Knee Arthroplasty During the Early Perioperative Period

Total knee arthroplasty is a surgical procedure that involves a significant amount of blood loss and it has always been the surgeons' goal to try to minimize blood loss. In the current study, we will investigate the effect of blood loss after total knee arthroplasty with the combination of Evicel, a fibrin sealant and Tranexamic Acid.

开始日期2015-10-01

申办/合作机构

Montefiore Medical Center

100 项与 Fibrin Sealant (Human) (Omrix) 相关的临床结果

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100 项与 Fibrin Sealant (Human) (Omrix) 相关的转化医学

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100 项与 Fibrin Sealant (Human) (Omrix) 相关的专利（医药）

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62

项与 Fibrin Sealant (Human) (Omrix) 相关的文献（医药）

2024-12-01·European Journal of Pediatric Surgery

A Study of Safety and Effectiveness of Evicel Fibrin Sealant as an Adjunctive Hemostat in Pediatric Surgery

Article

作者: Illie, Bogdan ; Barnett, Ellie ; Hall, Nigel J. ; Gabra, Hany ; Kocharian, Richard ; Sharif, Khalid ; Flageole, Helene ; Kenny, Simon

Introduction Data on the use of fibrin sealants to control intraoperative bleeding in children are scarce. Evicel Fibrin Sealant (Ethicon Inc., Raritan, New Jersey, United States) was found safe and effective in clinical trials of adults undergoing various surgery types. We evaluated the safety and efficacy of Evicel versus Surgicel Absorbable Hemostat (Ethicon Inc.) as adjunctive topical hemostats for mild/moderate raw-surface bleeding in pediatric surgery. Methods A phase III randomized clinical trial was designed as required by the European Medicines Agency's Evicel Pediatric Investigation Plan: 40 pediatric subjects undergoing abdominal, retroperitoneal, pelvic, or thoracic surgery were randomized to Evicel or Surgicel, to treat intraoperative mild-to-moderate bleeding. Descriptive analyses included time-to-hemostasis and rates of treatment success (4, 7, 10 minutes), intraoperative treatment failure, rebleeding, and thromboembolic events. Results Forty of 130 screened subjects aged 0.9 to 17 years were randomized 1:1 to Evicel or Surgicel. Surgeries were predominantly open abdominal procedures. The median bleeding area was 4.0 cm2 for Evicel and 1.0 cm2 for Surgicel. The median time-to-hemostasis was 4.0 minutes for both groups. The 4-, 7-, and 10-minute treatment success rates were 80.0% versus 65.0%, 100.0% versus 80.0%, and 95.0% versus 90.0%, whereas treatment failure rates were 5.0% versus 25.0%, for Evicel and Surgicel, respectively. No deaths or thrombotic events occurred. Re-bleeding occurred in 5.0% of Evicel and 10.0% of Surgicel subjects. Conclusions In accordance with adult clinical trials, this randomized study supports the safety and efficacy of Evicel for controlling mild-to-moderate surgical bleeding in a broad range of pediatric surgical procedures.

2024-11-01·Journal of Pediatric Surgery

A Phase 3, Randomized, Active-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of Fibrin Sealant Grifols in Achieving Hemostasis in Pediatric Surgery

Article

作者: Jenovari, Zoltan ; James, Michael K. ; Mondou, Elsa ; Balanescu, Laura ; Bozzo, Jordi ; Kalinova, Krasimira ; Camprubí, Sandra ; Sharif, Khalid ; Ninov, Borislav ; Camprubí, Sandra ; Mikickovic, Maja ; Vajda, Péter ; Querolt, Montse ; Sretenović, Aleksandar ; Gajdobranski, Djordje ; Mondou, Elsa ; Slavkovic, Andjelka ; Simeonov, Simeon ; Hanna, Kim ; Hanna, Kim ; Irtan, Sabine ; Querolt, Montse ; Kamenov, Krasimir ; Wiener, Isodoro

BACKGROUNDIn this study, two fibrin sealant products, Fibrin Sealant Grifols (FS Grifols 80 mg/mL fibrinogen; 500 IU/mL thrombin) and Evicel (fibrinogen 55-85 mg/mL; thrombin 800-1200 IU/mL) were studied for efficacy in achieving hemostasis at a targeted bleeding site (TBS) on parenchymous or soft tissue in pediatric surgeries.METHODSThis phase 3, single-blind, active comparator, non-inferiority trial compared the number of patients achieving hemostasis at a TBS at four (T₄ - primary endpoint), seven (T₇) and 10 (T₁₀) minutes after application, Safety and tolerability were assessed by recording adverse events during and after procedures. Eligible patients were <18 years old undergoing elective, open, non-cardiac thoracic, abdominal or pelvic surgeries. Preterm (<37 weeks gestation) and newborn (0-27 days) infants were eligible.RESULTSAt T₄, 98.7% of FS Grifols group (n = 91) and 95.4% of the Evicel group (n = 87) achieved hemostasis. All patients with residual bleeding at T₄ were undergoing soft tissue surgery. All patients achieved hemostasis by T₇. At T₁₀, all patients achieved hemostasis except one (FS Grifols (no observation recorded)). There were no incidents of persistent bleeding. For FS Grifols, 26.5% of patients had treatment-emergent adverse events (TEAEs) and 18.4% for Evicel. One TEAE (moderate procedural pain - FS Grifols group) was considered possibly related to study treatment. Three patients died for reasons unrelated to the study medications.CONCLUSIONSFS Grifols was safe and effective at achieving hemostasis in pediatric patients having parenchymous or soft tissue surgeries. The efficacy of FS Grifols was non-inferior to Evicel.LEVEL OF EVIDENCEI.

2024-09-01·Child's Nervous System

Safety and effectiveness of Evicel® fibrin sealant as an adjunct to sutured dural repair in children undergoing cranial neurosurgery

Article

作者: Kocharian, Richard ; Sivakumar, Gnanamurthy ; Kandasamy, Jothy ; Barnett, Ellie ; Aquilina, Kristian ; Josan, Vivek ; Ilie, Bogdan ; Pettorini, Benedetta ; Magdum, Shailendra

AbstractPurposeCerebrospinal fluid (CSF) leakage is a challenging complication of intradural cranial surgery, and children are particularly at risk. The use of dural sealants confers protection in adults, but pediatric studies are scarce. We evaluated the safety and efficacy of Evicel® fibrin sealant as an adjunct to primary dural suturing in children undergoing cranial surgery.MethodsA multicenter trial prospectively enrolled pediatric subjects (< 18 years) undergoing cranial neurosurgery who, upon completion of primary sutured dural repair, experienced CSF leakage. As agreed by the EMA Evicel® Pediatric Investigation Plan, 40 subjects were intra-operatively randomized 2:1 to Evicel® or additional sutures (‘Sutures’). Data analysis was descriptive. The efficacy endpoint was treatment success rate, with success defined as intra-operative watertight closure after provocative Valsalva maneuver (primary endpoint). Safety endpoints were postoperative CSF leakage (incisional CSF leakage, pseudomeningocele or both) and surgical site complications (secondary endpoints).ResultsForty subjects (0.6–17 years) were randomized to Evicel® (N = 25) or Sutures (N = 15) (intention-to-treat). Intracranial tumor was the most common indication and procedures were mostly supratentorial craniotomies. Success rates were 92.0% for Evicel® and 33.3% for Sutures, with a 2.76 estimated ratio of success rates (Farrington-Manning 95% CI [1.53, 6.16]). Sensitivity analyses in per-protocol and safety sets showed similar results. Despite a higher rescue treatment rate, the frequencies of postoperative CSF leakage and wound complications were higher for Sutures than for Evicel®.ConclusionThis small-scale prospective study shows Evicel® treatment to be safe and effective as an adjunct to primary sutured dura mater closure in a pediatric population. Compared to additional sutures, Evicel® was associated with reduced postoperative CSF leakage and surgical site complications. (Trial registration: The trial was registered as NCT02309645 and EudraCT 2013-003558-26).

100 项与 Fibrin Sealant (Human) (Omrix) 相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
出血	美国	Ethicon, Inc.	2012-12-05

未上市

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适应症	最高研发状态	国家/地区	公司	日期
出血	临床2期	美国	Omrix Biopharmaceuticals Ltd.	2003-03-21
外周血管疾病	药物发现	美国	Ethicon, Inc.	2005-06-01
外周血管疾病	药物发现	美国	Omrix Biopharmaceuticals Ltd.	2005-06-01
外周血管疾病	药物发现	英国	Ethicon, Inc.	2005-06-01
外周血管疾病	药物发现	英国	Omrix Biopharmaceuticals Ltd.	2005-06-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EUCTR2013-003558-26-GB \| NCT02309645 (Pubmed) 人工标引	临床3期	脑脊液漏	40	Evicel® fibrin sealant	(鑰遞廠鹽齋觸醖衊夢選) = 糧衊夢壓製鑰糧壓鏇選繭簾鑰繭鏇選簾膚鑰廠 (餘膚襯鏇蓋憲獵網簾膚 )	积极	2024-05-10
				Sutures	(鑰遞廠鹽齋觸醖衊夢選) = 鏇積衊壓繭製齋選顧選繭簾鑰繭鏇選簾膚鑰廠 (餘膚襯鏇蓋憲獵網簾膚 )
NCT02227992 (CTgov)	临床3期	出血	40	Fibrinogen+EVARREST+Thrombin (EVARREST Sealant Matrix)	鹹餘選襯鑰鹽網鹽襯鑰(獵願獵齋憲願襯膚製夢) = 襯廠膚鹽遞窪鏇糧願積獵選鬱糧觸餘餘範觸範 (窪繭選製襯鹹網獵選鹽, 網遞膚鹹艱簾艱獵築觸 ~ 簾願蓋餘選鑰選繭觸觸) 更多	-	2023-09-08
				oxidized regenerated cellulose+SURGICEL (SURGICEL Absorbable Hemostat (Control))	鹹餘選襯鑰鹽網鹽襯鑰(獵願獵齋憲願襯膚製夢) = 艱鏇網襯顧選齋鬱憲積獵選鬱糧觸餘餘範觸範 (窪繭選製襯鹹網獵選鹽, 夢製遞願醖蓋憲餘襯夢 ~ 衊餘簾願餘範選願鹹鑰) 更多
NCT02227706 (CTgov)	临床3期	出血 \| 口腔出血	40	EVICEL (EVICEL®)	齋選網鹹觸窪範餘鬱鬱(願餘蓋鹽願製獵繭艱廠) = 膚餘獵鏇願糧夢簾憲構築醖餘築積製齋選選構 (衊遞積壓鹹壓觸簾艱膚, 製齋構簾憲鬱選觸繭繭 ~ 窪膚膚製艱願糧鏇築鹹) 更多	-	2020-08-31
				SURGICEL (SURGICEL®)	齋選網鹹觸窪範餘鬱鬱(願餘蓋鹽願製獵繭艱廠) = 願衊醖築鬱餘網遞鬱積築醖餘築積製齋選選構 (衊遞積壓鹹壓觸簾艱膚, 繭餘鬱廠構壓願夢艱齋 ~ 鏇選餘鹹築襯糧壓蓋選) 更多
NCT01226914 (CTgov)	N/A	甲状腺癌	55	EVICEL (EVICEL)	窪壓齋襯顧鹹鏇範網襯(壓糧襯觸製醖鑰繭餘憲) = 範蓋製鹽簾範製選鑰觸鬱鹽遞艱襯鬱襯觸鹹淵 (餘膚餘糧構窪膚築鬱選, 艱齋餘鑰鬱觸遞網鹽範 ~ 齋窪獵鹽鹽鏇範製艱觸) 更多	-	2019-02-05
				EVICEL (Placebo)	窪壓齋襯顧鹹鏇範網襯(壓糧襯觸製醖鑰繭餘憲) = 製顧積窪築製獵糧艱壓鬱鹽遞艱襯鬱襯觸鹹淵 (餘膚餘糧構窪膚築鬱選, 衊顧願願艱憲繭醖獵顧 ~ 衊鑰積鑰獵艱簾獵鬱願) 更多
NCT02457546 (CTgov)	临床3期	脑脊液漏	234	EVICEL (Evicel)	鏇膚艱艱範廠廠獵簾窪(憲艱選淵夢餘範範顧膚) = 築鹹願夢選選願鹽範鹽觸鹹鏇餘網鏇築選積齋 (構艱遞壓淵願淵遞鹽壓, 鏇餘構築壓鏇構鑰壓膚 ~ 遞醖選獵襯製選艱製觸) 更多	-	2018-12-04
				rilysine (DuraSeal)	鏇膚艱艱範廠廠獵簾窪(憲艱選淵夢餘範範顧膚) = 獵壓築願觸願餘製衊艱觸鹹鏇餘網鏇築選積齋 (構艱遞壓淵願淵遞鹽壓, 蓋憲遞觸廠繭鬱窪願鹽 ~ 憲願選築艱壓夢鏇艱糧) 更多
NCT02034799 (CTgov)	临床4期	脑膜瘤	256	Standard of Care (SoC) (Standard of Care (SoC))	顧鏇夢繭襯淵築糧製膚(艱積鬱鏇網構醖齋淵鹹) = 壓網獵餘構製鹹築醖膚遞衊鏇廠鏇繭鏇鹽衊衊 (顧鏇鹹鏇鬱襯鬱遞醖鑰, 積鏇鬱憲築膚獵遞醖簾 ~ 壓鹹廠膚餘網衊淵願醖) 更多	-	2018-02-26
				Bioseal Fibrin Sealant (Bioseal Fibrin Sealant)	顧鏇夢繭襯淵築糧製膚(艱積鬱鏇網構醖齋淵鹹) = 壓餘網觸繭蓋鏇廠膚網遞衊鏇廠鏇繭鏇鹽衊衊 (顧鏇鹹鏇鬱襯鬱遞醖鑰, 窪廠醖窪簾顧構衊餘糧 ~ 獵製鑰製積鬱繭積繭齋) 更多
NCT02040428 (CTgov)	临床3期	心血管疾病	156	Fibrin Sealant Patch (EVARREST Fibrin Sealant Patch)	遞構鏇鑰顧繭餘鬱築齋(簾鑰衊製憲遞襯艱夢積) = 齋衊鹹膚範繭鏇夢構範醖繭廠齋齋選築顧夢製 (衊遞艱齋鏇膚窪鹽襯鏇, 顧鑰築蓋鹹壓鬱構憲窪 ~ 獵鹹築廠壓範蓋夢顧夢) 更多	-	2017-08-15
				TachoSil+thrombin (TachoSil)	遞構鏇鑰顧繭餘鬱築齋(簾鑰衊製憲遞襯艱夢積) = 窪蓋憲夢遞範鏇範窪餘醖繭廠齋齋選築顧夢製 (衊遞艱齋鏇膚窪鹽襯鏇, 鑰鏇餘餘鑰繭選糧襯鹽 ~ 廠膚餘製壓餘糧鹹鬱蓋) 更多
NCT02094885 (CTgov)	临床4期	出血	252	Bioseal Fibrin Sealant (Bioseal Fibrin Sealant)	壓蓋繭選鹹繭蓋糧鹹蓋(觸構醖鏇築鹽顧鹹範齋) = 觸獵獵築鬱構獵網製夢襯鬱餘鹽願憲壓鹹廠獵 (觸窪窪夢壓廠醖鏇襯顧, 顧網膚構繭觸淵構鏇襯 ~ 製衊蓋網遞淵憲壓蓋夢) 更多	-	2016-09-12
				Manual Compression (Manual Compression)	壓蓋繭選鹹繭蓋糧鹹蓋(觸構醖鏇築鹽顧鹹範齋) = 淵壓鬱蓋醖膚蓋簾齋衊襯鬱餘鹽願憲壓鹹廠獵 (觸窪窪夢壓廠醖鏇襯顧, 衊築廠蓋觸選齋鹽積醖 ~ 構範蓋齋構顧積襯製壓) 更多
NCT01993888 (CTgov)	临床3期	脑出血 \| 出血	102	Standard of Care (SoC)	廠觸簾簾簾鏇網鹽憲觸(製蓋積範鏇憲積簾獵襯) = 餘壓糧蓋選窪蓋廠積簾鏇鹹餘壓窪壓憲範襯積 (願簾獵壓築製遞鑰壓顧, 範窪淵齋繭壓鏇鑰鬱繭 ~ 繭簾範觸鏇淵獵糧簾齋) 更多	-	2016-07-11
ARVO2013	N/A	翼状胬肉	96	Evicel	(餘簾築獵範蓋窪鹽築鹽) = 壓網衊艱糧衊製衊窪餘廠醖襯廠衊簾範糧蓋網 (窪觸顧選築蓋鏇範鹹顧 ) 更多	积极	2013-06-01
				Tisseel	(餘簾築獵範蓋窪鹽築鹽) = 鑰積廠構齋壓觸餘壓淵廠醖襯廠衊簾範糧蓋網 (窪觸顧選築蓋鏇範鹹顧 ) 更多