A prospective, randomized controlled trial of fibrinogen concentrate (FC) plus standard of care versus standard of care alone in adult trauma patients with major bleeding or presumed major bleeding is developed to evaluate the efficacy and safety of prehospital administration of FC in trauma patients with suspected hypofibrinogenemia and active bleeding or presumed to be bleeding.
The main endpoints are:
1. Plasma fibrinogen levels in the first blood sample drawn at the patient's arrival at the trauma room and/or similar emergency bay dedicated to trauma and reanimation above the critical threshold of 2.0 g/l. As fibrinogen decreases early in trauma, its deficiency predicts massive bleeding and death.
2. Administration feasibility of FC within the prehospital setting.
Patients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC.

Start Date01 Jan 2025

Sponsor / Collaborator-

CTRI/2024/09/073878

/ Not yet recruitingPhase 3IIT

Evaluation of the effect of fibrinogen on peripartum hemorrhage in Placenta accreta spectrum (PAS) disorders, a double blind randomized controlled trial. - NIL

Start Date24 Sep 2024

Sponsor / Collaborator-

EUCTR2022-001759-17-DE

/ Not yet recruitingPhase 3

A multicenter, randomized, double-blind, placebo-controlled, parallel, phase 3 study to assess the efficacy and safety of fibrinogen concentrate (FGTW) in the management of bleeding in patients undergoing complex cardiac surgery (involving CPB)

Start Date15 Mar 2023

Sponsor / Collaborator

Laboratoire Français du Fractionnement et des Biotechnologies

100 Clinical Results associated with Fibrinogen Concentrate (Human)

100 Translational Medicine associated with Fibrinogen Concentrate (Human)

100 Patents (Medical) associated with Fibrinogen Concentrate (Human)

552

Literatures (Medical) associated with Fibrinogen Concentrate (Human)

01 Mar 2025·SEMINARS IN THROMBOSIS AND HEMOSTASIS

The History of Rare Bleeding Disorders

Review

Author: Yassini, Mahya S. ; Feily, Zahra ; Hassani, Saeed ; Torkamandi, Mohammad S. ; Ramezanzadeh, Narjes ; Fathalizade, Kimia ; Mahalleh, Roghayeh Gholizadeh Doran ; Hashemi, Farzaneh ; Kohzadi, Zhino ; Dorgalaleh, Akbar ; Khademi, Melika ; Tavasoli, Behnaz

Abstract:

Deficiencies in coagulation factors I (FI), FII, FV, combined FV and FVIII (CF5F8) and vitamin K-dependent coagulation factors FVII, FX, FXI, and FXIII have been referred to as rare bleeding disorders (RBDs), rare coagulation factor deficiencies (RCFDs), or recessively inherited coagulation disorders. Fibrinogen was most likely the first member of this group to be identified, with reports of its discovery spanning from 1859 to 1966. If not, then the first coagulation factor to be identified was prothrombin in 1894, and the last coagulation factor to be found was FX in 1956, about 60 years later. The first patient to be diagnosed with an RBD was a 9-year-old boy with afibrinogenemia in 1920 and the vitamin K-dependent coagulation factors deficiency was the most recent RBD in this group to be identified in a 3-month-old child in 1966. The initial therapeutic option for nearly all patients with RBDs was whole blood transfusion; this was replaced in 1941 by fresh frozen plasma (FFP), and then in later years by cryoprecipitate and coagulation factor concentrates. Fibrinogen concentrate was the first coagulation factor concentrate produced in 1956. Coagulation factor concentrate is now available for FI, FVII, FX, FXI, and FXIII; however, FFP and/or platelet transfusion are the only treatments available for FV deficiency. The only recombinant concentrates available for RBDs are for FVII and FXIII, which date from 1988 and the 2000s, respectively. Even though the clinical presentations, diagnosis, and management of lesser-known bleeding disorders have improved significantly in recent decades, more studies are needed to reveal the hidden aspects of these disorders in order to overcome diagnostic and therapeutic challenges and ultimately improve the quality of life for those who are affected.

01 Mar 2025·PEST MANAGEMENT SCIENCE

Synthesis of antibiofilm (1R,4S)‐(−)‐fenchone derivatives to control Pseudomonas syringae pv. tomato

Article

Author: Feng, Juntao ; Li, Linjing ; Wang, Yong ; Zhou, Jianbo ; Wang, Delong ; Fang, Yali ; Li, Yunpeng ; Chen, Yizhe ; Zhang, Zhijia ; Min, Shuoling

Abstract:

BACKGROUND:

Biofilm plays a crucial role in Pseudomonas syringae pv. tomato (Pst) infection. We identified (1R,4S)‐(−)‐fenchone (FCH) as the most potent antibiofilm agent against Pst among 39 essential oil compounds. Subsequently, we synthesized a series of FCH oxime ester and acylhydrazine derivatives to explore more potent derivatives.

RESULTS:

II3 was screened out as the most potent derivative, exhibiting a minimal biofilm inhibitory concentration of 60 μg mL−1 and a lowest concentration with maximal biofilm inhibition (LCMBI) of 200 μg mL−1, lower than those of FCH (80 and 500 μg mL−1, respectively). II3 and FCH showed minimum inhibitory concentration values >1000 μg mL−1 and similar maximal biofilm inhibition extents of 48.7% and 49.5% at their respective LCMBIs, respectively. Meanwhile, neither of them influenced cell viability or the activity of metabolic enzymes at their respective LCMBIs. II3 at its LCMBI significantly reduced biofilm thickness, extracellular polysaccharide content, and pectinase and cellulase production indices. In vivo assay results indicated that II3 could preventatively reduce the bacterial contents in tomato leaves at its LCMBI, and when combined with kasugamycin (KSG) (10 μg mL−1), II3 achieved the same level of bacterial reduction as the sole application of KSG (70 μg mL−1), thereby reducing the required dosage of KSG. Mechanistic studies demonstrated that II3 can down‐regulate biofilm‐related genes and inhibit PsyR/PsyI quorum sensing system, which differs from the bactericidal mechanisms.

CONCLUSION:

These results underscore the potential of II3 as an antibiofilm agent for the control of Pst or FCH as a promising natural candidate for future in‐depth optimization. © 2024 Society of Chemical Industry.

01 Feb 2025·JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH

Fresh frozen plasma, fibrinogen concentrate, and antithrombin concentrate administration for obstetrical disseminated intravascular coagulation by the Japanese previous and new criteria

Article

Author: Takeda, Yoshiharu ; Makino, Shintaro ; Itakura, Atsuo ; Hyodo, Hironobu ; Eto, Eriko ; Adachi, Tomoko ; Morikawa, Mamoru ; Kobayashi, Takao ; Matsunaga, Shigetaka ; Serizawa, Mariko ; Nii, Masafumi ; Takeda, Jun

Abstract:

Aim:

The purpose of this study is to clarify the frequencies of fresh frozen plasma (FFP) ± fibrinogen concentrate administration (fibrinogen concentrate [FC] therapy) and antithrombin (AT) concentrate administration (AT therapy) for the women with obstetrical disseminated intravascular coagulation (DIC).

Methods:

Two retrospective multicenter case–control studies as Study‐1 (January–December 2018) and Study‐2 (July 2022–June 2023) were conducted. Study‐1 was the historical control of Study‐2. All participants experienced a blood loss of ≥1000 mL during vaginal delivery or ≥2000 mL during cesarean section. All participants were subsequently assigned to the DIC group or non‐DIC group.

Results:

Study‐1 comprised 175 women (obstetrical DIC, 27; control, 148; by the previous criteria) and Study‐2 comprised 175 women (obstetrical DIC, 9; control, 166; by the new criteria). The frequencies of FFP (±FC therapy) or FC therapy in DIC group were significantly higher than non‐DIC group in Study‐1 (88.9% vs. 25.0%, 44.4% vs. 4.0%) and Study‐2 (100% vs. 24.7%, 77.8% vs. 5.4%); however, the frequencies of AT therapy were similar. Furthermore, in the DIC group, all women with fibrinogen <150 mg/dL received FFP ± FC therapy in Study‐1 (n = 19) and Study‐2 (n = 8); however, those with AT activity <70% received AT therapy (16.7% [4/24] and 12.5% [1/8], respectively).

Conclusion:

We revealed an association between the high frequency of FFP ± FC therapy and lower fibrinogen levels, but a low frequency of AT therapy regardless of AT activity, in obstetrical DIC regardless of diagnosis criteria.

News (Medical) associated with Fibrinogen Concentrate (Human)

14 Feb 2024

·www.fiercepharma.com

Grifols readies US, EU approval push for blood clot treatment after phase 3 success

BT524 can be administered to “patients on the operating table immediately," Grifols explained. Grifols is readying an approval run at U.S. and European regulators on the back of a phase 3 win for the Spanish plasma medicine producer's concentrated form of a blood clotting factor. The product, dubbed BT524, is a concentrated form of fibrinogen, a glycoprotein that is essential for blood clot formation and stops excessive bleeding resulting from injuries or surgery. Grifols was testing BT524 in a late-stage study of patients with acquired fibrinogen deficiency (AFD), which it described as an “underserved growth market.” The Barcelona, Spain-based company announced this morning that the product had met the study’s primary endpoint, demonstrating its noninferiority to standard of care when it came to reducing blood loss in patients with AFD who underwent spinal or abdominal surgery, while also “maintaining an excellent safety profile.” Specifically, mean blood loss was 1,444 mL among the BT524 cohort compared with 1,735 mL among patients who received standard of care. It meant patients receiving Grifols’ product lost an average of 291 mL less blood. AFD usually occurs during surgery when a patient’s body contains insufficient fibrinogen to arrest bleeding. It is typically treated with a plasma extract called cryoprecipitate or fresh frozen plasma, which both contain fibrinogen. However, both of these treatment options contain various other unneeded proteins and elements, meaning that large volumes are required to ensure the patient receives sufficient fibrinogen, Grifols explained in the release. They also need to be thawed before use, which is not only time-consuming but can put patients’ lives at risk, the company added. In contrast, BT524 can be administered to “patients on the operating table immediately,” who will only receive the fibrinogen necessary to prevent hemorrhaging, Grifols explained. The company’s plan is to kick off the approval process in both Europe and the U.S. in the fourth quarter of the year. If successful, it would mark the first fibrinogen concentrate approved for AFD in the U.S., Grifols noted. “The positive results for fibrinogen are an important milestone and strengthen a Grifols innovation strategy that’s diversified across plasma and non-plasma, balanced between internal and external investments, and includes both shorter- and longer-term development cycles,” Grifols’ chief operating officer, Victor Grifols Deu, said in the release. While Grifols has its eye on the first fibrinogen concentrate approval for AFD in the U.S., its competitors have had more luck getting their own versions to market for congenital fibrinogen deficiency. CSL Behring got RiaSTAP approved in that indication as far back as 2009, while Switzerland’s Octapharma followed suit with Fibryga in 2017. Since then, Fibryga has also received approval to treat AFD across Europe off the back of a phase 2 study. Meanwhile, Grifols is in the midst of an ongoing legal battle with Gotham City Research after the New York hedge fund accused the company of wrongful accounting practices.

Drug ApprovalClinical ResultPhase 3Phase 2

11 Jun 2021

·www.biospace.com

Fibrinogen Concentrate Market Size to Reach USD 4.19 Billion in 2028, Says Reports and Data

Increasing preference for fibrinogen concentrate over fresh-frozen plasma, rising incidence of bleeding disorders, and increasing number of fibrinogen product approvals are some key factors driving market growth Market Size – USD 2.61 Billion in 2020, Market Growth – at a CAGR of 6.1%, Market Trends – Rising R&D investment to accelerate development of advanced fibrinogen products The global fibrinogen concentrate market size is expected to reach USD 4.19 Billion in 2028 at a CAGR of 6.1%, according to the latest report by Reports and Data. Increasing R&D activities to develop new therapies for bleeding disorders, rising demand for fibrinogen concentrates to treat congenital deficiencies, and high incidence of bleeding disorders across the globe are key factors expected to drive market revenue growth over the forecast period. In addition, increasing number of advanced and innovative in pipeline to treat bleeding disorders is also expected to contribute to revenue growth of the market going ahead. Fibrinogen concentrate is a lyophilized and purified human plasma fibrinogen and is widely used as an alternative to traditional sources of fibrinogen, which is a natural blood protein playing a vital role in coagulation process. Fibrinogen concentrate has been extensively used and recommended for bleeding disorders and acquired coagulation disorders in several countries across the globe as it significantly improves blood clot firmness and minimizes the need for postoperative transfusion. Fibrinogen concentrate can either be plasma-derived or a recombinant and is often used for afibrinogenemia and dysfibrinogenemia. Increasing research is being carried out across the globe to expand its application scope to use it for conditions such as hemorrhage resuscitation. This is expected to contribute to revenue growth of the market going ahead. New product launches and approvals of fibrinogen concentrates are also expected to be a key factor driving market growth. In addition, increasing focus of key players on developing advanced fibrinogen concentrates to treat bleeding disorders is also a key market growth driving factor. However, adverse reactions associated with fibrinogen concentrate such as arterial thrombosis, dyspnea, nausea, and others are expected to hamper market growth to a certain extent over the forecast period. Access Free sample PDF Copy of the Report @ Some Key Highlights from the Report: Human fibrinogen type segment is expected to account for largest revenue share in the global market over the forecast period owing to increasing need for fibrinogen concentrate to treat bleeding disorders and congenital coagulation deficiencies. Congenital fibrinogen deficiency segment is expected to register robust revenue CAGR over the forecast period owing to high incidence of hemophilia, rising rate of bleeding disorders, proven safety and efficiency of fibrinogen concentrates and rapid advancements in fibrinogen products. North America is expected to dominate other regional markets over the forecast period owing to increasing geriatric population and high rate of bleeding disorders, advancements in diagnostics and therapeutics, and robust presence of key players in the region. Major companies in the market include CSL Behring, Baxter, Johnson & Johnson (Ethicon), LFB Group, ProFibrix BV (The Medicines Company), Shanghai RAAS, Jiangxi Boya Bio-Pharmaceutical, Hualan Biological Engineering, Harbin Pacific Biopharmaceutical, and Greencross. In November 2019, Octapharma AG announced approval for use of fibryga, which is a lyophilised human fibrinogen concentrate for intravenous infusion, in treatment of acquired fibrinogen deficiency in 15 European countries. Buy now your Exclusive copy of Report @ For the purpose of this report, Reports and Data has segmented the global fibrinogen concentrate market on the basis of type, application type, and region: Type Outlook (Revenue, USD Billion; Volume in Tons, 2018–2028) Human Animal Application Type Outlook (Revenue, USD Billion; Volume in Tons, 2018–2028) Congenital Fibrinogen Deficiency Surgical Procedures Request for Custom Research @ Regional Outlook (Revenue, USD Billion; Volume in Tons, 2018–2028) North America U.S. Canada Mexico Europe Germany U.K. France Italy BENELUX Rest of APAC Asia Pacific China India Japan South Korea Rest of APAC Latin America Brazil Rest of Latin America Middle East & Africa U.A.E. Saudi Arabia South Africa Rest of MEA Explore Reports and Data's Prime Analysis of the global Pharmaceutical & Healthcare Industry: Hemostasis Analyzers Market Analysis, By Product (Laboratory analyzer, POC testing,) By Test Type (Prothrombin Time, Fibrinogen, Activated Partial and others) By Technology Type (Mechanical and others) By End-Use (Diagnostic Centers, Hospitals, and others), Forecasts to 2026 Product (Revenue, USD Million; 2016-2026) Bovine Blood Plasma Derivatives Market Size, Share & Trends, By Type (Bovine Serum, FBS, Bovine Serum Albumin, Fibrinogen, Protein Ingredient, Others), By Application (Scientific Research, Industrial Production, Feed, Others), And Regional Forecasts To 2027 Coagulation Analyzers Market Size, Share & Analysis, By Product, By Technology (Mechanical, Electrochemical) By Test Types (APTT, D-Dimer, Fibrinogen, PT) By End Use (Hospitals, Research Institutes), And Segment, Forecasts To 2028 About Reports and Data Reports and Data is a market research and consulting company that provides syndicated research reports, customized research reports, and consulting services. Our solutions purely focus on your purpose to locate, target and analyze consumer behavior shifts across demographics, across industries and help client’s make a smarter business decision. We offer market intelligence studies ensuring relevant and fact-based research across a multiple industries including Healthcare, Technology, Chemicals, Power and Energy. We consistently update our research offerings to ensure our clients are aware about the latest trends existent in the market. Reports and Data has a strong base of experienced analysts from varied areas of expertise. Contact Us: John W Head of Business Development Reports and Data | Web: Direct Line: +1-212-710-1370 E-mail: sales@reportsanddata.com Read Full Press Release:

100 Deals associated with Fibrinogen Concentrate (Human)

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hemorrhage	United States	CSL Behring GmbH	16 Jan 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acquired fibrinogen deficiency	Phase 3	-	CSL Behring LLC	01 Oct 2009
Afibrinogenemia	Phase 3	-	CSL Behring LLC	01 Oct 2009
Postpartum Hemorrhage	Phase 2	-	CSL Behring LLC	01 Jan 2021
Coronary Artery Disease	Phase 2	United States	CSL Behring LLC	01 Jan 2011
Heart Valve Diseases	Phase 2	United States	CSL Behring LLC	01 Jan 2011
Heart Diseases	Phase 2	Brazil	CSL Behring LLC	01 Aug 2010
Aortic Aneurysm	Phase 2	Germany	CSL Behring LLC	01 Jun 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03932240 (Pubmed \| Anesth Analg)	Phase 3	First line	36	Cryoprecipitate	cjgaqzgduz(mzjdkycjxo) = tpxwjiasdg cszeeksfss (fxdogcvvtg, -1081.3 to -10.4) View more	Positive	08 Aug 2024
				Fibrinogen concentrate (RiaSTAP)	cjgaqzgduz(mzjdkycjxo) = ymgtjxhsnz cszeeksfss (fxdogcvvtg, 291.1 - 1361.9) View more
NCT03932240 (CTgov)	Phase 3	-	36	Fibrinogen Concentrate (FC) (Fibrinogen Concentrate (FC))	etfjrgbvxd(bwbljupqhj) = ykutfjmhaq dhqkipooyl (tdoarxqfml, foxgdbpjsz - cxzonyotan) View more	-	20 Mar 2023
				Cryoprecipitate (Cryoprecipitate)	etfjrgbvxd(bwbljupqhj) = zwtznninic dhqkipooyl (tdoarxqfml, wzykhmidfj - zpmnrgrwvf) View more
NCT02822599 (RiaSTAP, CTgov)	Phase 4	Hemorrhage \| Afibrinogenemia	30	RiaStAP (RiaSTAP)	wjrjxjndtt(ijgdltzstb) = dyaytmplvq owssvfwdpy (xpzqnwuwvv, uevquhrqvv - ujiqflzlys) View more	-	16 Sep 2021
				Saline (Saline)	wjrjxjndtt(ijgdltzstb) = zijckcfutf owssvfwdpy (xpzqnwuwvv, mwukjrmttk - hbyvcbliqh) View more
ISTH2020	Not Applicable	Thrombocytopenia	-	Fibrinogen concentrate	zpkshxekvg(leslglgrat) = rshqhmsjzx selnakgypo (qgizlqbwut )	-	12 Jul 2020
NCT01623531 (CTgov)	Phase 3	Intraoperative Complications	62	Fibrinogen (RiaSTAP)	vlwqmkzyfn(vmcbkvkgcp) = xocddbmzum wlohrkwwpf (fjhmrlzgfr, ovymvjrdym - qsubmioiud) View more	-	22 May 2020
				Fibrinogen (Intravenous Saline)	vlwqmkzyfn(vmcbkvkgcp) = scshcclltm wlohrkwwpf (fjhmrlzgfr, ygzdxkporg - wuqkkynrzp) View more
ESC2018	Not Applicable	-	299	Fibrinogen concentrate	zgxhwwrqmj(xwmfarzilh) = wozyahplad krekjxrynj (jdlgifxyfn ) View more	Positive	27 Aug 2018
				Fibrinogen concentrate	zgxhwwrqmj(xwmfarzilh) = uidjgbowpf krekjxrynj (jdlgifxyfn ) View more
NCT02540434 (TOP-CLOT, CTgov)	Not Applicable	Blood Coagulation Disorders	19	RiaSTAP+ROTEM (RiaSTAP Arm)	dkgcczpjrt(uljysquybz) = hayycqywaz dxcjvnuuvj (ukdejainal, jxnyswhufc - qcijvjihff) View more	-	12 May 2017
				Cryoprecipitate (Cryopreciptiate Arm)	dkgcczpjrt(uljysquybz) = dhjmflyeoa dxcjvnuuvj (ukdejainal, inhegvtuji - ineyzghrsq) View more
NCT01283321 (RiaCT, CTgov)	Phase 2	Coronary Artery Disease \| Heart Valve Diseases	26	Human fibrinogen concentrate (Group A: RiaSTAP)	zxzqouiyxj(ihcvkuxoys) = dcilbaplpb zidlnfmokt (vbbzetcowg, 0.0) View more	-	16 Feb 2015
				apheresis platelets (Group B: Apheresis Platelets)	zxzqouiyxj(ihcvkuxoys) = sqcfaqqwyv zidlnfmokt (vbbzetcowg, 0.3) View more
NCT03884725 (Pubmed \| J Thorac Cardiovasc Surg)	Phase 4	-	63	Fibrinogen concentrate	itctrgpmdz(ltqvetdywh) = jaofbykssq ygyirrozre (jydiukrqpv, 157 - 750)	Positive	01 Oct 2014
				Cryoprecipitate	itctrgpmdz(ltqvetdywh) = fsdqfijvqj ygyirrozre (jydiukrqpv, 215 - 510)
NCT01300286 (CTgov)	Phase 4	Hemorrhage	23	RiaSTAP	rlotswwwsg(xcfyairbpp) = fwifmlgkuq icvjojuqtt (jglvocrvrh, 49) View more	-	16 Jun 2014

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Fibrinogen Concentrate (Human)

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation