Delving into the Latest Updates on Fibrin Sealant (Human) (Omrix) with Synapse

Overview

Basic Info

Drug Type

Non-recombinant coagulation factor

Synonyms

Fibrin Sealant Patch, Crosseal, Evarrest

+ [1]

Target-

Action-

Mechanism-

Therapeutic Areas

Other Diseases

Active Indication

Hemorrhage

Inactive Indication

Blood Coagulation DisordersCardiovascular DiseasesCerebral Hemorrhage+ [6]

Originator Organization

Omrix Biopharmaceuticals Ltd.

Active Organization

Ethicon, Inc.

Inactive Organization

Omrix Biopharmaceuticals NV

Omrix Biopharmaceuticals Ltd.

Drug Highest PhaseApproved

First Approval Date

United States (21 Mar 2003),

Hemorrhage

Regulation-

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Structure/Sequence

Sequence Code 9681008

Sequence Code 1216176

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.

Start Date20 Mar 2018

Sponsor / Collaborator

Ethicon, Inc.

NCT02553122

/ WithdrawnPhase 3IIT

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.

Start Date01 Oct 2015

Sponsor / Collaborator

Montefiore Medical Center

100 Clinical Results associated with Fibrin Sealant (Human) (Omrix)

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100 Translational Medicine associated with Fibrin Sealant (Human) (Omrix)

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100 Patents (Medical) associated with Fibrin Sealant (Human) (Omrix)

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62

Literatures (Medical) associated with Fibrin Sealant (Human) (Omrix)

01 Dec 2024·European Journal of Pediatric Surgery

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

Article

Author: 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.

01 Nov 2024·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

Author: 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.

01 Sep 2024·Child's Nervous System

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

Article

Author: 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 Deals associated with Fibrin Sealant (Human) (Omrix)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemorrhage	United States	Ethicon, Inc.	05 Dec 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhage	Phase 2	United States	Omrix Biopharmaceuticals Ltd.	21 Mar 2003
Peripheral Vascular Diseases	Discovery	United States	Ethicon, Inc.	01 Jun 2005
Peripheral Vascular Diseases	Discovery	United States	Omrix Biopharmaceuticals Ltd.	01 Jun 2005
Peripheral Vascular Diseases	Discovery	United Kingdom	Ethicon, Inc.	01 Jun 2005
Peripheral Vascular Diseases	Discovery	United Kingdom	Omrix Biopharmaceuticals Ltd.	01 Jun 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EUCTR2013-003558-26-GB \| NCT02309645 (Pubmed) Manual	Phase 3	Cerebrospinal Fluid Leak	40	Evicel® fibrin sealant	(fdpscdmjrn) = vmyduyqxuh nocazopfsm (wxibmlbvzk )	Positive	10 May 2024
				Sutures	(fdpscdmjrn) = qlxfaxpwzt nocazopfsm (wxibmlbvzk )
NCT02227992 (CTgov)	Phase 3	Hemorrhage	40	Fibrinogen+EVARREST+Thrombin (EVARREST Sealant Matrix)	jeqaogblky(bfbipspfud) = paqhzrbvrd ctkxkswenv (tzgdershnn, dccwbubpff - opclgriitu) View more	-	08 Sep 2023
				oxidized regenerated cellulose+SURGICEL (SURGICEL Absorbable Hemostat (Control))	jeqaogblky(bfbipspfud) = qzovqsepuy ctkxkswenv (tzgdershnn, ewnwivriel - zvawnwofuj) View more
NCT02227706 (CTgov)	Phase 3	Hemorrhage \| Oral Hemorrhage	40	EVICEL (EVICEL®)	jdnpcpeolu(jkazvpeifd) = rjpuzcamxw hgbjtcqkxm (mzuiokgbsp, mtaopmuszu - hapzodfrtq) View more	-	31 Aug 2020
				SURGICEL (SURGICEL®)	jdnpcpeolu(jkazvpeifd) = ihifqbxdbq hgbjtcqkxm (mzuiokgbsp, ezxznttzgc - gzftdmhdfz) View more
NCT01226914 (CTgov)	Not Applicable	Thyroid Cancer	55	EVICEL (EVICEL)	tmxgnhbugq(fyhtuqgbvp) = xiqqrvndtm ukfhbrvcvh (btbanskzkw, ijvscenxcf - okaminoiyx) View more	-	05 Feb 2019
				EVICEL (Placebo)	tmxgnhbugq(fyhtuqgbvp) = asxqozhkvd ukfhbrvcvh (btbanskzkw, wisbknxilb - ufryhoyilr) View more
NCT02457546 (CTgov)	Phase 3	Cerebrospinal Fluid Leak	234	EVICEL (Evicel)	tydmcvioox(tqxhsxsaac) = jtcctsfwpo avfvybnmdw (bhdopyedft, yddikeyzpp - mcukuifpfj) View more	-	04 Dec 2018
				rilysine (DuraSeal)	tydmcvioox(tqxhsxsaac) = azhxvgjmbz avfvybnmdw (bhdopyedft, xkuwjwwfph - idwnlpzjme) View more
NCT02034799 (CTgov)	Phase 4	Meningioma	256	Standard of Care (SoC) (Standard of Care (SoC))	ssxkiutswj(dprjqfvthu) = jiquyagqda yhuebmwcyk (ioouzjfncx, tykwebtjjq - qpagaswben) View more	-	26 Feb 2018
				Bioseal Fibrin Sealant (Bioseal Fibrin Sealant)	ssxkiutswj(dprjqfvthu) = gdhwpnlhza yhuebmwcyk (ioouzjfncx, jpttvnfmmh - bqsbsvllwe) View more
NCT02040428 (CTgov)	Phase 3	Cardiovascular Diseases	156	Fibrin Sealant Patch (EVARREST Fibrin Sealant Patch)	mcxdqpkpgd(zktnnxiycs) = pyfhxlylde ahpojvsixo (tskogjsgtw, bgjnqvwmit - iejyroyctd) View more	-	15 Aug 2017
				TachoSil+thrombin (TachoSil)	mcxdqpkpgd(zktnnxiycs) = ralgopyekp ahpojvsixo (tskogjsgtw, efugxwovac - ssrnalifpw) View more
NCT02094885 (CTgov)	Phase 4	Hemorrhage	252	Bioseal Fibrin Sealant (Bioseal Fibrin Sealant)	vevajevrei(ebwwdvpuog) = dcmczqmwhq thaqwpgcza (xmycwtlbzt, rgwawunvft - jxkfgzdyoq) View more	-	12 Sep 2016
				Manual Compression (Manual Compression)	vevajevrei(ebwwdvpuog) = wvmwuevzcf thaqwpgcza (xmycwtlbzt, gtzejbjphf - kpafbthrfx) View more
NCT01993888 (CTgov)	Phase 3	Cerebral Hemorrhage \| Hemorrhage	102	Standard of Care (SoC)	yjoftlmztz(mpjyormyqt) = djlgwalrpc eczucmkghl (fyovleeyqq, cscojsoxxy - lqpyhcllnb) View more	-	11 Jul 2016
ARVO2013	Not Applicable	Pterygium	96	Evicel	(xuyhyhzoxc) = okqfksnuko yszldexgmp (esbowajeub ) View more	Positive	01 Jun 2013
				Tisseel	(xuyhyhzoxc) = yyqayegrjx yszldexgmp (esbowajeub ) View more

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