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 recruitingNot Applicable

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-

NCT05449834

/ CompletedPhase 3IIT

Fibrinogen Early In Severe Trauma StudY II

Annually over 7000 Australians are treated for severe trauma. Haemorrhage secondary to severe trauma is a major cause of potentially preventable death and poor outcomes in Australian adults. Severe trauma may trigger changes in blood clotting mechanisms and factor levels leading to inhibition of clot formation and reduced clot strength. This results in the inability of the severely injured trauma patient to form adequate clots to help stop bleeding. There is good evidence to suggest the loss of clotting factors during haemorrhage is associated with worse outcomes and it is thought the early replacement of these factors may reduce bleeding and improve patient outcomes. Fibrinogen is a key clotting factor that helps bind clots together and early fibrinogen replacement may improve outcomes.
Currently fibrinogen is replaced using cryoprecipitate, a blood product made from blood donated by healthy donors which is a precious resource. It can take a significant amount of time to administer as it is frozen and stored in the blood bank. Timely administration of cryoprecipitate is difficult as it requires thawing prior to transfusion. The large doses of cryoprecipitate used in traumatic haemorrhage can put strain on local blood banks in supplying requested units in a timely manner. Additionally, the widely dispersed population of Australia introduces logistic challenges to the maintenance of adequate cryoprecipitate stocks to individual hospital blood banks, especially in remote regions. However, cryoprecipitate contains a number of other coagulation factors (not just fibrinogen) that may be instrumental in clot formation and resistance to fibrinolysis.
Fibrinogen concentrate is an alternative product used to assist in blood clotting. It is a dry powder form of fibrinogen and can be reconstituted at the bedside and given quickly. The use of a fibrinogen factor concentrate with a long shelf life that is easy to use has significant implications for both large urban metropolitan areas and remote isolated communities.
The timing and mode of fibrinogen replacement in traumatic haemorrhage has implications for patient outcomes, blood product availability, costs and the national blood supply. Despite the importance of fibrinogen replacement in traumatic haemorrhage, there have been no clinical trials powered for clinical outcomes directly comparing fibrinogen concentrate and cryoprecipitate. FEISTY II will evaluate the efficacy, safety and cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate in trauma patients with major haemorrhage.
FEISTY II is a phase III randomised trial which will enrol 850 patients from Australian and New Zealand major trauma centres, with a primary patient outcome of days alive out of hospital at day 90 after injury. Severely injured trauma patients who require blood transfusion and have evidence of low fibrinogen levels will be randomised to receive either fibrinogen concentrate or standard care with cryoprecipitate

Start Date21 Nov 2022

Sponsor / Collaborator

Australian and New Zealand Intensive Care Research Centre

[+3]

100 Clinical Results associated with Fibrinogen Concentrate (Human)

100 Translational Medicine associated with Fibrinogen Concentrate (Human)

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

480

Literatures (Medical) associated with Fibrinogen Concentrate (Human)

01 Sep 2026·THROMBOSIS AND HAEMOSTASIS

Pharmacokinetics, Hemostatic Efficacy, and Safety of a New Human Fibrinogen Concentrate in Adult and Pediatric Patients with Congenital Fibrinogen Deficiency

Article

Author: Schuettrumpf, Joerg ; Abraha, Salomon ; Miesbach, Wolfgang ; Bohlaender, Fabian ; Khelif, Abderrahim ; Boehm, Heike ; Adolf, Sonia ; Meddeb, Balkis ; El-Beshlawy, Amal ; Djambas Khayat, Claudia ; Aigner, Silke

Congenital fibrinogen deficiencies are rare coagulopathies which are treated by fibrinogen concentrates. This trial investigated the pharmacokinetic/pharmacodynamic (PK/PD) parameters, and surrogate efficacy and safety of a new human fibrinogen concentrate (HFC), BT524, in patients with congenital afibrinogenemia or severe hypofibrinogenemia.This prospective, multi-national, open-label, single-arm PK/PD trial evaluated PK/PD parameters of HFC (part 1; phase I) and HFC as on-demand treatment or prophylaxis for bleeding events (part 2; phase III). In part 1, patients received a single-dose of HFC (70 mg/kg body weight [BW]). PK/PD parameters were calculated using a PK/PD model and non-compartmental analysis. Fibrinogen antigen (FiAg) levels were determined over 14 days by immunonephelometry and fibrinogen activity (FiAc) by Clauss assay. The efficacy variable was mean change in maximum clot firmness (MCF) analyzed by thromboelastometry. Safety parameters were evaluated for 49 days.A total of 27 patients (n = 15 adults, n = 12 children) were treated with HFC. For FiAg, mean (SD) PK parameters were: Cmax 1.81 (0.42) g/L, AUC0-∞ 173 (45.4) g*h/L, and t1/2 67.9 (15.3) h. For FiAc, they were Cmax 1.26 (0.4) g/L, AUC0-∞ 104 (33.5) g*h/L, and t1/2 60.3 (13.3) h. In adults, MCF significantly increased 1 h after HFC infusion (11.1 (5.1) mm; P < 0.0001; 95% CI: 9.33–14.47). In pediatrics, mean increase in range was 9.3 to 16.5 mm. Treatment-related adverse events were rare, with one mild increase in fibrin D-dimer. No thromboembolic events, hypersensitivity, or allergic reactions were observed.HFC effectively increased FiAg levels and FiAc, improved clot firmness, and showed a favorable safety and tolerability profile in adult and pediatric patients with congenital fibrinogen deficiency.

01 Sep 2026·Anesthesiology clinics

Viscoelastic Hemostatic Assays in Postpartum Hemorrhage and Pregnancy

Review

Author: Kowalczyk, John J ; Farber, Michaela K ; Bhat, Adithya D

Viscoelastic hemostatic assays (VHAs), such as thromboelastography, rotational thromboelastometry, and Quantra, are increasingly used to guide postpartum hemorrhage (PPH) resuscitation. We review device principles, reference ranges, transfusion thresholds, and algorithmic integration. Pregnancy-specific VHA thresholds identify hypofibrinogenemia requiring replacement with cryoprecipitate or fibrinogen concentrate. Algorithms with VHA-guided bundles may reduce massive PPH morbidity and allogeneic transfusion requirements. VHA platelet indices correlate only at low counts; anticoagulants and temperature/pH can confound results. VHA-enabled, threshold-based algorithms expedite targeted therapy in PPH, reduce plasma exposure, and complement standard laboratories and clinical judgment.

01 Oct 2026·BRITISH JOURNAL OF ANAESTHESIA

Impact of fibrinogen concentrate on simulated dilutional coagulopathy in pregnant patients: a pilot in vitro study

Article

Author: Furman, Matthew ; Kowalczyk, John J ; Katz, Daniel J

News (Medical) associated with Fibrinogen Concentrate (Human)

09 Sep 2026

·www.prnewswire.com

Fewer Blood Components Transfused with fibryga® Than Cryoprecipitate, Secondary Analysis of Prespecified FIBRES Subgroups Reports

Findings published in the peer-reviewed Journal of Cardiothoracic and Vascular Anesthesia Secondary findings do not change the primary outcomes of the FIBRES trial PARAMUS, N.J. and TORONTO, Sept. 9, 2026 /PRNewswire/ -- A prespecified secondary analysis of the landmark FIBRES trial demonstrated that fibryga® (fibrinogen [human]) significantly reduced 24-hour allogeneic blood-product (ABP) transfusion requirements versus cryoprecipitate in two predefined, overlapping subgroups: patients in a non-critical state before surgery and patients undergoing elective surgery.1 These findings have been published as a peer-reviewed article in the Journal of Cardiothoracic and Vascular Anesthesia, titled Superiority of Fibrinogen Concentrate Versus Cryoprecipitate for Treatment of Bleeding in Cardiac Surgery Patients: A Secondary Analysis of the FIBRES Randomized Clinical Trial Stratified by Surgical Risk. The newly published analysis evaluated two subgroups that had been defined before the trial results were analyzed. Results from this analysis do not change the primary conclusion of the primary FIBRES trial. In the overall study population, fibryga® met the trial's prespecified criterion for non-inferiority to cryoprecipitate.2,3 "These findings provide additional evidence and guidance around fibrinogen replacement in cardiac surgery patients who develop clinically significant bleeding and acquired hypofibrinogenemia," said Justyna Bartoszko, M.D., lead author of the analysis and a member of the FIBRES Research Group. "Blood transfusions can be lifesaving, but an efficient patient blood management strategy seeks to avoid unnecessary exposure to allogeneic blood components, as they are known to increase the risk of postoperative complications."4 Findings from the secondary subgroup analysis The first subgroup consisted of participants from the FIBRES trial who were determined to be in a non-critical state before surgery (n=634), representing 86% of the primary analysis population. In this subgroup, there was a 19% relative reduction in ABP units transfused within 24 hours in patients receiving fibryga® versus cryoprecipitate (13.6 units vs. 16.2 units). The second subgroup consisted of FIBRES trial participants undergoing elective surgery (n=466), representing 63% of the primary analysis population. In this subgroup, there was a 19% relative reduction in ABP units transfused within 24 hours in patients receiving fibryga® versus cryoprecipitate (11.7 units vs. 14.4 units). "When clinically appropriate for a patient with acquired fibrinogen deficiency, a standardized fibrinogen concentrate provides targeted replacement," said Huub Kreuwel, Ph.D., Vice President of Medical Affairs, Octapharma USA.5 "While the primary results from FIBRES have not changed, secondary analyses such as these provide relevant information about specific patient subgroups which may be useful for informing institutional patient blood management protocols." Safety findings In the full study population, 248 (66.7%) patients in the fibryga® group and 264 (72.7%) patients in the cryoprecipitate group experienced treatment-emergent adverse events during the study (relative risk, 0.92; 95% CI, 0.83-1.01; P=0.07). Within the elective-surgery subgroup, adverse events were less frequent among patients assigned to fibryga® than among patients assigned to cryoprecipitate (relative risk, 0.85; 95% CI, 0.75-0.97; P=0.02). Serious adverse events were also less frequent among fibryga® recipients in the elective surgery subgroup (relative risk, 0.71; 95% CI, 0.52-0.99; P=0.04). No treatment-emergent AEs, SAEs, or deaths in the study were deemed to be possibly or probably related to FC or cryoprecipitate. These findings should not be interpreted as establishing an overall safety advantage, and the safety of fibryga® should be evaluated in accordance with its current U.S. prescribing information. About the FIBRES trial The U.S. Food and Drug Administration's approval of fibryga® for fibrinogen replacement in patients with acquired fibrinogen deficiency (AFD) was supported by the landmark FIBRES study published in JAMA. The study demonstrated that fibrinogen concentrate is non-inferior to cryoprecipitate in managing bleeding following cardiac surgery, with the added benefits of standardized dosing, faster preparation, and reduced risk of viral transmission. FIBRES was an investigator-initiated, pragmatic, multicenter, randomized clinical trial conducted at 11 Canadian hospitals (ClinicalTrials.gov Identifier NCT03037424). The study enrolled adults undergoing cardiac surgery who developed clinically significant bleeding and acquired hypofibrinogenemia after cardiopulmonary bypass for whom fibrinogen replacement was ordered. The FIBRES trial was supported by an unrestricted grant from Octapharma, which also provided the fibrinogen concentrate used in the study. Funding was also provided by the Canadian Institutes of Health Research. Cryoprecipitate was provided by Canadian Blood Services and Héma-Québec. Full author disclosures are reported in the published article. A total of 827 patients were randomized. Of these, 735 patients received study treatment and were included in the primary analysis: 372 received fibryga® and 363 received cryoprecipitate. Each ordered dose consisted of 4 grams of fibryga® or 10 units of cryoprecipitate during the first 24 hours after cardiopulmonary bypass. The primary endpoint was the cumulative number of allogeneic blood-component units – red blood cells, platelets and plasma – administered during the first 24 hours after bypass. In the overall population, the mean number of blood-component units administered was 16.3 with fibryga® and 17.0 with cryoprecipitate. The ratio of the means was 0.96, with a two-sided 95% confidence interval of 0.84 to 1.09. The trial met its prespecified non-inferiority criterion, with P<0.001 for non-inferiority. The test for superiority in the overall population was not statistically significant, with P=0.50. About fibryga ® fibryga® is a human fibrinogen concentrate indicated for: fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency; and treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. fibryga® is not indicated for dysfibrinogenemia. Contraindications Anaphylactic or severe reactions to fibryga® or its components (Sodium Citrate Dihydrate; Glycine; L-Arginine Hydrochloride). Warnings and Precautions Monitor patients for early signs of hypersensitivity or allergic reactions. If necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving fibryga®. Treatment with human fibrinogen concentrate in congenital fibrinogen deficiency has been associated with thrombosis at target plasma fibrinogen levels that were below 150 mg/dL. The thrombotic risks may be greater when the target fibrinogen plasma level is 150 mg/dL. Weigh the benefits of administration versus the risks of thrombosis. fibryga® is made from pooled human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Adverse Reactions The most serious adverse reactions that may be observed with fibryga® are thromboembolic episodes and anaphylactic-type reactions. The most common adverse reactions observed in clinical studies with fibryga® in acquired fibrinogen deficiency (>5% of patients) were abnormal hepatic function, acute kidney injury, anemia, atrial fibrillation, delirium and renal failure. The most common adverse reactions observed in clinical studies with fibryga® in congenital fibrinogen deficiency (>5% of patients) were nausea, vomiting, pyrexia (fever), and thrombocytosis. For full prescribing information, please visit fibrygausa.com/pi. For more information on fibryga®, please visit fibrygausa.com. About Octapharma Octapharma is one of the world's largest human protein manufacturers, developing and producing therapies from human plasma and human cell lines. Headquartered in Lachen, Switzerland, Octapharma has over 11,000 employees and serves patients in 117 countries across Immunotherapy, Hematology, and Critical Care. With seven R&D sites, five manufacturing facilities in Europe, and more than 200 plasma donation centers in the U.S. and Europe, Octapharma has delivered trusted therapies for over 40 years. The company is committed to improving lives through innovation, quality, and a deep focus on patient care and clinical partnership. To learn more please visit . References Bartoszko J, Karkouti K, Callum JL; FIBRES Research Group. Superiority of Fibrinogen Concentrate Versus Cryoprecipitate for Treatment of Bleeding in Cardiac Surgery Patients: A Secondary Analysis of the FIBRES Randomized Clinical Trial Stratified by Surgical Risk. J Cardiothorac Vasc Anesth. Published online June 17, 2026. doi:10.1053/j.jvca.2026.06.019. Callum JL, Farkouh ME, Scales DC, et al.; FIBRES Research Group. Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery: The FIBRES Randomized Clinical Trial. JAMA. 2019;322(20):1966-1976. doi:10.1001/jama.2019.17312. Fibryga® [Fibrinogen (Human)]. U.S. Prescribing Information. Octapharma USA, Inc. Revised August 2025. U.S. Centers for Disease Control and Prevention. The National Healthcare Safety Network (NHSN) Manual: Biovigilance Component Hemovigilance Module Protocol. Version 3.0. January 2026. Prokopchuk-Gauk O, Shih A, Nahirniak S, et al. NAC Statement on Fibrinogen Concentrate Use in Acquired Hypofibrinogenemia. National Advisory Committee on Blood and Blood Products. December 15, 2014 [last updated February 26, 2025]. Available at: . MEDIA CONTACT: Fred Feiner Yankee Public Relations [email protected] 908-425-4878 FIBR-0551 SOURCE Octapharma 21% more press release views with Request a Demo

Clinical ResultAHAClinical Study

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.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Diseases	Phase 3	Italy	CSL Behring LLC	01 Nov 2011
Afibrinogenemia	Phase 3	-	CSL Behring LLC	01 Oct 2009
Postpartum Hemorrhage	Phase 2	United Kingdom	CSL Behring GmbH	07 May 2013
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
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


NCT05780125 (Pubmed \| Anesth Analg)	Phase 2	-	-	FibCLOT	pydnevkeud(wsvtlhmreq) = bnjfrtwxdg dbjvzazvbr (wqpoxmsjww, 1.2)	Negative	01 Apr 2025
				RiaSTAP	pydnevkeud(wsvtlhmreq) = bafcuqtwqi dbjvzazvbr (wqpoxmsjww, 1.6)
NCT03932240 (CTgov)	Phase 3	-	36	Fibrinogen Concentrate (FC) (Fibrinogen Concentrate (FC))	jxvuwfetcm(rewxzzhccw) = kugdiwnglr oeewjmgzqk (zenvtcwxcm, pkysqzdlaz - zkjmbpiqnc) View more	-	20 Mar 2023
				Cryoprecipitate (Cryoprecipitate)	jxvuwfetcm(rewxzzhccw) = vdyhllxqxn oeewjmgzqk (zenvtcwxcm, qneqjdwfij - vpyyeyydfb) View more
NCT02822599 (RiaSTAP, CTgov)	Phase 4	Hemorrhage \| Afibrinogenemia	30	RiaStAP (RiaSTAP)	egtgglorew(liwashuqeo) = ifigvbwsmu omldqmvfej (qbncnqtzru, cjyhmatvpc - wnotcssobz) View more	-	16 Sep 2021
				Saline (Saline)	egtgglorew(liwashuqeo) = nnlafjqzku omldqmvfej (qbncnqtzru, vrsniutpuw - avjyfyugta) View more
NCT01623531 (CTgov)	Phase 3	Intraoperative Complications	62	Fibrinogen (RiaSTAP)	jwzjhyvuzb(npmjitigoy) = efsunpvddx watthvlwrp (ldgszdyuwf, kovkbwddcu - vxbcvycynv) View more	-	22 May 2020
				Fibrinogen (Intravenous Saline)	jwzjhyvuzb(npmjitigoy) = hkvpmwdsll watthvlwrp (ldgszdyuwf, lxkxveukpa - pmbrshoric) View more
NCT01623531 (Pubmed \| Acta Anaesthesiol Scand)	Not Applicable	-	62	Fibrinogen concentrate	nrqjikjyby(euzlxoqbdv) = uubxfxndbw nijkybqyqn (udwmjpvfbi )	-	01 May 2020
				Placebo	nrqjikjyby(euzlxoqbdv) = pcrcdlgrzl nijkybqyqn (udwmjpvfbi )
NCT02540434 (TOP-CLOT, CTgov)	Not Applicable	Blood Coagulation Disorders	19	RiaSTAP+ROTEM (RiaSTAP Arm)	zobqqggfgd(dvmiwcuiuj) = ketqqjeskb gtpjvekqcr (belrhsgrog, fiutrgstqp - dxuzgmogvr) View more	-	12 May 2017
				Cryoprecipitate (Cryopreciptiate Arm)	zobqqggfgd(dvmiwcuiuj) = dlsbbufqvy gtpjvekqcr (belrhsgrog, qvjmyqhdtx - hwfaehdzsl) View more
EUCTR2009-018086-12-NL \| NCT01124981 (Pubmed \| JAMA)	Phase 2/3	Blood Loss, Surgical	120	Fibrinogen concentrate	ftadujocfx(zurmifyhuh) = ivlsyvmdst unkupapzpw (ppqdpbsxhs )	Negative	21 Feb 2017
				Placebo	ftadujocfx(zurmifyhuh) = pwfqsigpqu unkupapzpw (ppqdpbsxhs )
NCT01471730 (Pubmed \| J Am Heart Assoc)	Phase 3	First line	119	Fibrinogen concentrate	sydmjwxfvp(yqkktsygwb) = shnxrsfbhk wnbncekudl (pyytizmlei )	Positive	02 Jun 2015
				Saline solution	sydmjwxfvp(yqkktsygwb) = nfazzuxghw wnbncekudl (pyytizmlei )
NCT01283321 (RiaCT, CTgov)	Phase 2	Coronary Artery Disease \| Heart Valve Diseases	26	Human fibrinogen concentrate (Group A: RiaSTAP)	yqamlpshwf(kdnhjsukzj) = vivfiukgrm cnolqzgadw (ryiwjhnysm, 0.0) View more	-	16 Feb 2015
				apheresis platelets (Group B: Apheresis Platelets)	yqamlpshwf(kdnhjsukzj) = hummoggjcn cnolqzgadw (ryiwjhnysm, 0.3) View more
NCT01300286 (CTgov)	Phase 4	Hemorrhage	23	RiaSTAP	hknbdqnwfl(jraajvrwsx) = phngubgivg ysryxxvrdk (uojeaynosb, 49) View more	-	16 Jun 2014

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