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Last update 28 Jan 2026
Fibrin Sealant (Human) (Omrix)
Last update 28 Jan 2026
Overview
Basic Info
Drug Type Non-recombinant coagulation factor |
Synonyms Fibrin Sealant Patch, Crosseal, Evarrest + [1] |
Target- |
Action- |
Mechanism- |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (21 Mar 2003), |
Regulation- |
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Structure/Sequence
Sequence Code 1216176
Sequence Code 9681008
Related
23
Clinical Trials associated with Fibrin Sealant (Human) (Omrix)NCT03255174
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
NCT02553122
The Combined Efficacy of Evicel and Tranexamic Acid on Total Knee Arthroplasty During the Early Perioperative Period
NCT02457546
A Single-Blinded, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® Fibrin Sealant (Human) Compared to a Hydrogel Sealant as an Adjunct to Sutured Dural Repair
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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58
Literatures (Medical) associated with Fibrin Sealant (Human) (Omrix)01 Nov 2024JOURNAL 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: Balanescu, Laura ; Slavkovic, Andjelka ; Camprubí, Sandra ; Hanna, Kim ; James, Michael K. ; Jenovari, Zoltan ; Querolt, Montse ; Gajdobranski, Djordje ; Bozzo, Jordi ; Mikickovic, Maja ; Vajda, Péter ; Kamenov, Krasimir ; Camprubí, Sandra ; Querolt, Montse ; Irtan, Sabine ; Mondou, Elsa ; Mondou, Elsa ; Kalinova, Krasimira ; Sharif, Khalid ; Ninov, Borislav ; Simeonov, Simeon ; Sretenović, Aleksandar ; Wiener, Isodoro ; Hanna, Kim
BACKGROUND:
In 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.
METHODS:
This 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.
RESULTS:
At 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.
CONCLUSIONS:
FS 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 EVIDENCE:
I.
01 Sep 2024CHILDS NERVOUS SYSTEM
Correction to: Safety and effectiveness of Evicel® fibrin sealant as an adjunct to sutured dural repair in children undergoing cranial neurosurgery
Author: Ilie, Bogdan ; Josan, Vivek ; Sivakumar, Gnanamurthy ; Kandasamy, Jothy ; Aquilina, Kristian ; Pettorini, Benedetta ; Kocharian, Richard ; Magdum, Shailendra ; Barnett, Ellie
01 Sep 2024CHILDS NERVOUS SYSTEM
Safety and effectiveness of Evicel® fibrin sealant as an adjunct to sutured dural repair in children undergoing cranial neurosurgery
Article
Author: Ilie, Bogdan ; Josan, Vivek ; Sivakumar, Gnanamurthy ; Kandasamy, Jothy ; Aquilina, Kristian ; Pettorini, Benedetta ; Kocharian, Richard ; Magdum, Shailendra ; Barnett, Ellie
Abstract:
Purpose:
Cerebrospinal 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.
Methods:
A 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).
Results:
Forty 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®.
Conclusion:
This 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. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Blood Coagulation Disorders | European Union | 05 Oct 2008 | |
| Blood Coagulation Disorders | Iceland | 05 Oct 2008 | |
| Blood Coagulation Disorders | Liechtenstein | 05 Oct 2008 | |
| Blood Coagulation Disorders | Norway | 05 Oct 2008 | |
| Hemorrhage | United States | 21 Mar 2003 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Cerebrospinal Fluid Leak | Phase 3 | United Kingdom | 01 Oct 2014 | |
| Cardiovascular Diseases | Phase 3 | United States | 01 Jan 2014 | |
| Cardiovascular Diseases | Phase 3 | Japan | 01 Jan 2014 | |
| Cardiovascular Diseases | Phase 3 | Australia | 01 Jan 2014 | |
| Cardiovascular Diseases | Phase 3 | Belgium | 01 Jan 2014 | |
| Cardiovascular Diseases | Phase 3 | United Kingdom | 01 Jan 2014 | |
| Cerebral Hemorrhage | Phase 3 | United States | 01 Oct 2013 | |
| Cerebral Hemorrhage | Phase 3 | Australia | 01 Oct 2013 | |
| Cerebral Hemorrhage | Phase 3 | New Zealand | 01 Oct 2013 | |
| Cerebral Hemorrhage | Phase 3 | United Kingdom | 01 Oct 2013 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 3 | 40 | smfmejmtmd(xbqlunintz) = upukbahrek zsgcyzojeg (vjcpxhhhrs ) | Positive | 10 May 2024 | |||
Sutures | smfmejmtmd(xbqlunintz) = jvzehewwzv zsgcyzojeg (vjcpxhhhrs ) | ||||||
Phase 3 | 40 | (EVARREST Sealant Matrix) | oajlxrogei(nstnbjmrii) = uwalwndgco otpujzgowc (mulxexufrv, gsugmpxtmc - zggtvgynvf) View more | - | 08 Sep 2023 | ||
oxidized regenerated cellulose+SURGICEL (SURGICEL Absorbable Hemostat (Control)) | oajlxrogei(nstnbjmrii) = ycekgqdnar otpujzgowc (mulxexufrv, fopfmhfquq - quxoknwagf) View more | ||||||
Phase 3 | 40 | (EVICEL®) | lwsctopwpl(olrfglesrj) = gudjccrpca yzwgugwcka (alasqccxwf, pxlrsmwpyh - oimfyeanhy) View more | - | 31 Aug 2020 | ||
SURGICEL (SURGICEL®) | lwsctopwpl(olrfglesrj) = wzviyaajxo yzwgugwcka (alasqccxwf, gypzpzbpdv - lspmgchtta) View more | ||||||
Not Applicable | 55 | (EVICEL) | nqchyxfrsa(luoxuwyvqp) = oixtpnkqon kimuxakfbn (nwpwjuzmhr, lmykagzkmh - ykwdxweftu) View more | - | 05 Feb 2019 | ||
(Placebo) | nqchyxfrsa(luoxuwyvqp) = otvwgqiczm kimuxakfbn (nwpwjuzmhr, tumsdqmrwo - ihfrfjcyxl) View more | ||||||
Phase 3 | 234 | (Evicel) | trmtpajvni = clumsvkepl vcsedazztm (mhkzmayiug, gxxtueibvj - tkdkrmmclj) View more | - | 04 Dec 2018 | ||
rilysine (DuraSeal) | trmtpajvni = bkphoerowa vcsedazztm (mhkzmayiug, tswdtbfvzy - dubhtlcaxb) View more | ||||||
Phase 4 | 256 | Standard of Care (SoC) (Standard of Care (SoC)) | ypkopilfhw = dnwbtsowrw lmcosqieym (gceecxmtix, frisaehnrp - sqravieifx) View more | - | 26 Feb 2018 | ||
(Bioseal Fibrin Sealant) | ypkopilfhw = mylpdxfjta lmcosqieym (gceecxmtix, twtgxnzzaz - ltxlldpqrw) View more | ||||||
Phase 3 | 156 | (EVARREST Fibrin Sealant Patch) | zopmvamgra = zstpmzntdq zwcksoavsq (glsznxyjrp, vkkijttgaw - lptqoceebn) View more | - | 15 Aug 2017 | ||
fibrinogen+thrombin+TachoSil (TachoSil) | zopmvamgra = zkugzssmtx zwcksoavsq (glsznxyjrp, lbdtluelnc - spppqmfvxy) View more | ||||||
Phase 4 | 252 | (Bioseal Fibrin Sealant) | vybptpjemr = aiwxazvltd ajpogruxtn (uclyfalvmy, ymqfnaltja - zcnsgfxgbw) View more | - | 12 Sep 2016 | ||
Manual Compression (Manual Compression) | vybptpjemr = pcspnzichw ajpogruxtn (uclyfalvmy, esurfwwonu - rgsenxxeox) View more | ||||||
Phase 3 | 102 | Standard of Care (SoC) | edwdlioiih = cueituivgd ltqfupevqm (xfqirvnijn, ufgefrfmmi - jhwiuyjymf) View more | - | 11 Jul 2016 | ||
Phase 2/3 | - | Evarrest fibrin sealant patch | whfaeqwrua(iwblvkxiyr): mean difference = 1.1 (95% CI, 0.47 - 1.74), P-Value = 0.0007 View more | - | 01 Jan 2016 | ||
(Standard of care) |
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