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

NCT05449834 / RecruitingPhase 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

[+2]

NCT02528708 / WithdrawnPhase 1/2IIT

A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH)

In this prospective, single-center, randomized, placebo-controlled, double-blind clinical trial, parturients with primary PPH are eligible for treatment with fibrinogen concentrate following both vaginal delivery and cesarean section complicated by an estimated blood loss (EBL) >1000 mL and an ongoing bleeding notwithstanding standard treatment measures (volume replacement, uterine massage, and uterotonic agents).

Start Date01 Jan 2021

Sponsor / Collaborator

Yale University

[+1]

100 Clinical Results associated with Fibrinogen Concentrate (Human)

100 Translational Medicine associated with Fibrinogen Concentrate (Human)

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

140

Literatures (Medical) associated with Fibrinogen Concentrate (Human)

01 Jan 2024·Trauma surgery & acute care open

Hemostatic effect of fibrinogen concentrate on traumatic massive hemorrhage: a propensity score matching study

Article

Author: Chang, Sung Wook ; Kim, Dong Hun ; Ma, Dae Sung ; Lee, Seok Won ; Heo, Yoonjung

Background:

Fibrinogen concentrate (FC) can be administered during massive transfusions to manage trauma-induced coagulopathy. However, its effectiveness in survival remains inconclusive due to scarce high-level evidence. This study aimed to investigate the hemostatic effects of FC regarding mortality in massive hemorrhage caused by trauma.

Methods:

This retrospective study analyzed 839 patients who received massive transfusions (red blood cells (RBCs) ≥5 units in 4 hours or ≥10 units in 24 hours) at a level I trauma center between 2015 and 2022. Patients who were transferred to other hospitals or were deceased upon arrival, suffered or died from severe brain injury, and were aged 15 years or less were excluded (n=334). 1:2 propensity score matching was performed to compare the ‘FC (+)’ group who had received FC in 24 hours (n=68) with those who had not (‘FC (−)’, n=437). The primary outcome was mortality, and the secondary outcomes included transfusion volume.

Results:

The variables for matching included vital signs, injury characteristics, prehospital time, implementation of resuscitative endovascular balloon occlusion of the aorta, and blood gas analysis results. The administration of FC did not significantly reduce or predict mortality (in-hospital, 24 hours, 48 hours, or 7 days). The FC (−) group received more units of RBC (25.69 units vs. 16.71 units, p<0.001, standardized mean difference [SMD] 0.595), fresh frozen plasma (16.79 units vs. 12.91 units, p=0.023, SMD 0.321), and platelets (8.76 units vs. 5.46 units, p=0.002, SMD 0.446) than the FC (+) group.

Conclusion:

The use of FC did not show survival benefits but reduced transfusion requirements in traumatic massive hemorrhages, highlighting a need for future investigations. In the future, individualized goal-directed transfusion with FC may play a significant role in treating massive bleeding.

Level of evidence:

IV, retrospective study having more than one negative criterion.

01 Jan 2024·Journal of cardiothoracic and vascular anesthesia

Prospective, Randomized Study of Fibrinogen Concentrate Versus Cryoprecipitate for Correcting Hypofibrinogenemia in Cardiac Surgery Patients

Article

Author: Vakhrushev, Ivan ; Kuanyshbek, Aidyn ; Ayaganov, Dauren ; Li, Tatyana

OBJECTIVE:

Cardiac surgery with cardiopulmonary bypass (CPB) is associated with hypofibrinogenemia and severe bleeding requiring transfusion. Guidelines recommend cryoprecipitate or fibrinogen concentrate (FC) for the treatment of acquired hypofibrinogenemia. This study compared cryoprecipitate and FC for the correction of acquired hypofibrinogenemia and the associated costs.

DESIGN:

A single-center, prospective, randomized study evaluating patients with hypofibrinogenemia after cardiac surgery. The primary endpoint was direct treatment cost. Secondary endpoints included the change in fibrinogen level after FC and/or cryoprecipitate dosing.

SETTING:

A single-center study in Astana, Kazakhstan.

PARTICIPANTS:

Participants who underwent CPB from 2021 to 2022 and developed clinically significant bleeding and hypofibrinogenemia.

INTERVENTIONS:

Patients were randomized to receive cryoprecipitate or FC.

MEASUREMENTS AND MAIN RESULTS:

Eighty-eight adult patients with acquired hypofibrinogenemia (<2.0 g/L) after CPB were randomized to receive cryoprecipitate (N = 40) or FC (N = 48), with similar demographics between groups. Overall, mean ± SD 9.33 ± 0.94 units (range, 8-10) cryoprecipitate or 1.40 ± 0.49 g (1-2) FC was administered to the 2 groups. From before administration to 24 hours after, mean plasma fibrinogen increased by a mean ± SD of 125 ± 65 and 96 ± 65 mg/dL in the cryoprecipitate and FC groups, respectively. At 48 hours after administration, there was no significant difference in fibrinogen levels between groups. The mean direct cost of treatment with FC was significantly lower than with cryoprecipitate (p < 0.0001): $1,505.06 ± $152.40 and $631.75 ± $223.67 per patient for cryoprecipitate and FC, respectively.

CONCLUSION:

Analysis of plasma fibrinogen concentration showed that cryoprecipitate and FC had comparable effectiveness. However, FC is advantageous over cryoprecipitate due to its ease of handling, lower cost, and high purity.

01 Sep 2023·British journal of clinical pharmacology

Population pharmacokinetic modelling of fibrinogen in patients with congenital or acquired—chronic or acute—hypofibrinogenaemia

Article

Author: Montoro, Bruno ; Colom, Helena ; Arevalo, Angel-Guillermo ; Sabate, Antoni ; Blasi, Annabel ; Cendros, Josep Maria

Aims:

Fibrinogen is the key substrate for coagulation. Fibrinogen pharmacokinetics (PK) after single doses of fibrinogen concentrate (FC), using modelling approaches, has only been evaluated in congenital afibrinogenaemic patients. The aims of this study are to characterize the fibrinogen PK in patients with acquired—chronic (cirrhosis) or acute—hypofibrinogenaemia (critical haemorrhage), showing endogenous production. Influencing factors of differences on the fibrinogen PK between subpopulations will be identified.

Methods:

A total of 428 time–concentration values from 132 patients were recorded. Eighty‐two out of 428 values were from 41 cirrhotic patients administered with placebo and 90 out of 428 were from 45 cirrhotic patients that were given FC, 161 out of 428 values were from 14 afibrinogenaemic patients and 95 out of 428 values were from 32 severe acute trauma haemorrhagic patients. A turnover model that accounted for endogenous production and exogenous dose was fitted using NONMEM74. The production rate (Ksyn), distribution volume (V), plasma clearance (CL) and concentration yielding to 50% of maximal fibrinogen production (EC50) were estimated.

Results:

Fibrinogen disposition was described by a one‐compartment model with CL and V values of 0.0456 L·h−1 and 4.34 L·70 kg−1, respectively. Body weight was statistically significant in V. Three different Ksyn values were identified that increased from 0.00439 g·h−1 (afibrinogenaemia), to 0.0768 g·h−1 (cirrhotics) and 0.1160 g·h−1 (acute severe trauma). EC50 was of 0.460 g·L−1.

Conclusions:

This model will be key as a support tool for dose calculation to achieve specified target fibrinogen concentrations, in each of the studied populations.

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

14 Feb 2024

·pipelinereview.com

Biotest successfully meets primary endpoint in phase III trial with Fibrinogen concentrate

DREIEICH, Germany I February 14, 2024 I Biotest announced today that the AdFIrst ( Ad justed FI brinogen r eplacement st rategy) phase III trial met its primary endpoint, demonstrating that Fibrinogen concentrate is non-inferior to standard of care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency undergoing planned major spinal or abdominal surgery. Mean blood loss measured in the two treatment groups were 1,444 mL in the Fibrinogen concentrate group versus 1,735 mL in the standard of care group, resulting in a reduction of blood loss of 291 mL in patients treated with fibrinogen concentrate. The AdFIrst trial was a prospective, randomised, active-controlled, multicentre phase III trial involving 222 patients undergoing elective spine or abdominal surgery. The main purpose of this phase III trial was to demonstrate that Fibrinogen concentrate improves clotting function and reduces blood loss in the management of severe haemorrhage as effectively as standard of care. The efficacy and safety of Fibrinogen concentrate was compared with the centres’ standard of care, either fresh frozen plasma or cryoprecipitate. “We are very pleased to have successfully completed this clinical trial. Our focus is now on preparing the marketing authorization applications,” said Dr Silke Aigner, Senior Director Clinical Strategy & Development at Biotest AG. “There is a high medical need for additional fibrinogen concentrates to ensure availability of fibrinogen for more patients in this severe medical situation.” The results of Biotest’s two clinical trials, the AdFIrst trial and the completed phase I/III trial in patients with congenital fibrinogen deficiency, will serve as the basis for approval of Fibrinogen concentrate for the treatment of patients with congenital and acquired fibrinogen deficiency. Initial applications for marketing authorisations are planned in Europe and US. This would be the first fibrinogen concentrate approved for an acquired fibrinogen deficiency indication in the US. In much of the world today, standard of care to control severe surgical bleeding is fibrinogen replacement through cryoprecipitate or fresh frozen plasma, treatments that contain not only fibrinogen but also other proteins and elements that a patient might not need. Worldwide, there are only two other fibrinogen concentrates authorised in multiple countries for acquired fibrinogen deficiency, but they are not approved in the US. As part of the Grifols Group, Biotest intends to play a leading role in making this therapy available in a broader patient population. Compared with congenital fibrinogen deficiency, where efficacy has been demonstrated in an earlier trial, the market size for the treatment of acquired fibrinogen deficiency is many times larger. There is a worldwide market potential of USD 800 million. The market in the US, in particular, has great development potential, as therapy with fibrinogen concentrate is not established there. Detailed results of the trial will be presented later this year. About Biotest’s Fibrinogen concentrate The newly developed manufacturing process of the fibrinogen concentrate leads to high-purity fibrinogen with a defined concentration, high level of viral safety and good solubility. About AdFIrst trial no. 995 The AdFIrst trial was a prospective, active-controlled, multicentre phase III trial investigating the efficacy and safety of the Fibrinogen concentrate (BT524) in patients with acquired fibrinogen deficiency. Patients who had high blood loss during planned spinal or abdominal surgery were randomized 1:1 to treatment with Fibrinogen concentrate (BT524) or fresh frozen plasma (FFP)/Cryoprecipitate. To evaluate the efficacy of BT524, blood loss was compared between the both treatment options. Further information about the trial design can be found at www.clinicaltrialsregister.eu (EudraCT number: 2017-001163-20). About fibrinogen and fibrinogen deficiency Fibrinogen is a blood clotting factor that is produced in the liver. It plays a key role in primary haemostasis (stopping blood loss from bleeding wounds) and wound healing. In case of a lack or shortage of fibrinogen blood’s ability to clot is impaired which leads to a much greater risk of bleeding and delayed haemostasis. The fibrinogen concentrate alternatives fresh frozen plasma (FFP) and cryoprecipitate contain variable amounts of fibrinogen and must be thawed prior to treatment. The defined amount of fibrinogen in the fibrinogen concentrate will allow a tailor-made, patient specific and highly effective therapy. About Biotest Biotest is a provider of biological therapeutics derived from human plasma. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange. Since May 2022, Biotest has been a part of the Grifols Group, based in Barcelona, Spain (www.grifols.com). SOURCE: Biotest

Phase 3Clinical Result

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	US	CSL Behring GmbH	16 Jan 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Afibrinogenemia	Phase 2	BR	CSL Behring LLC	01 Aug 2010
Heart Diseases	Phase 2	BR	CSL Behring LLC	01 Aug 2010
Aortic Aneurysm	Phase 2	DE	CSL Behring LLC	01 Jun 2008

Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03932240 (CTgov)	Phase 3	-	36	Fibrinogen Concentrate (FC) (Fibrinogen Concentrate (FC))	mvdjeephnd(dvhtrqjlpr) = ytiivjdyww psrgetmpcr (glfspvnkzk, ocrihjciyy - tabkpbrobj) View more	-	20 Mar 2023
				Cryoprecipitate (Cryoprecipitate)	mvdjeephnd(dvhtrqjlpr) = mjtgwdvobb psrgetmpcr (glfspvnkzk, vfunoimmsd - brezuvxlre) View more
NCT02822599 (CTgov)	Phase 4	Hemorrhage \| Afibrinogenemia	30	RiaStAP (RiaSTAP)	ryaxgisjyp(nwrwwjzqkb) = vbvcxxxhwu ghcgbivlpt (pchgxjirin, mqkqodnayd - uxqgbqjqzd) View more	-	16 Sep 2021
				Saline (Saline)	ryaxgisjyp(nwrwwjzqkb) = ocxypnnlrg ghcgbivlpt (pchgxjirin, bolhitqrev - klxtkoqgna) View more
ISTH2020	Not Applicable	Thrombocytopenia	-	Fibrinogen concentrate	nbijdqjwnf(tgsrdwunns) = sountkmido xqpopueahu (tikbynvuln )	-	12 Jul 2020
NCT01623531 (CTgov)	Phase 3	Intraoperative Complications	62	Fibrinogen (RiaSTAP)	oirtxoljec(pcovmddmzi) = fcbsuidamz swntokznmp (avjliribbr, rmktyewwql - hpdcazrlnc) View more	-	22 May 2020
				Fibrinogen (Intravenous Saline)	oirtxoljec(pcovmddmzi) = dvikqlhrcm swntokznmp (avjliribbr, zkbvoijvtg - jleierwnyq) View more
Pubmed \| Acta Anaesthesiol Scand	Not Applicable	-	62	Fibrinogen concentrate	dqaompxpqq(vwijcqatsa) = xyhmvugrjm zvrxxgxvmq (zrxykyvstk )	-	01 May 2020
				Placebo	dqaompxpqq(vwijcqatsa) = wftkfyxojn zvrxxgxvmq (zrxykyvstk )
ESC2018	Not Applicable	-	299	Fibrinogen concentrate	csdigspsvt(gmgjjocogv) = oudsqcglwo gplvrwlkjt (zdgttqovxr ) View more	Positive	27 Aug 2018
				Fibrinogen concentrate	csdigspsvt(gmgjjocogv) = gvmvetysge gplvrwlkjt (zdgttqovxr ) View more
NCT02540434 (TOP-CLOT, CTgov)	Not Applicable	Blood Coagulation Disorders	19	RiaSTAP+ROTEM (RiaSTAP Arm)	blmfvqiysg(zbaqmrxpdh) = rmimxjpzzf ssoewegrpa (mkxqzrdkkb, mwyfdsfemx - leyuesrrzq) View more	-	12 May 2017
				Cryoprecipitate (Cryopreciptiate Arm)	blmfvqiysg(zbaqmrxpdh) = eqjlfqgdml ssoewegrpa (mkxqzrdkkb, yucuvecqnc - xqicrkaqlo) View more
EUCTR2009-018086-12-NL \| NCT01124981 (Pubmed \| JAMA)	Phase 2/3	Blood Loss, Surgical	120	Fibrinogen concentrate	kahafpjdwe(falnxozrot) = vrmkkgqctr ofmexziltg (vmxrcsggli )	Negative	21 Feb 2017
				Placebo	kahafpjdwe(falnxozrot) = cnvsfldbll ofmexziltg (vmxrcsggli )
NCT00968045 (Pubmed \| Br J Anaesth)	Not Applicable	-	48	Fibrinogen concentrate	xqgkyjklrc(gmpmwdwmiu) = zcadbwnjsi uxcekloylw (ijmfrtcxwl )	-	01 Feb 2016
				Placebo	xqgkyjklrc(gmpmwdwmiu) = oeidhecyjv uxcekloylw (ijmfrtcxwl )
NCT01471730 (Pubmed \| J Am Heart Assoc)	Phase 3	First line	119	Fibrinogen concentrate	tlvqunsnmq(ghmmnobozi) = aktjbbyree kcvwaioxit (qkjicfyupa )	Positive	02 Jun 2015
				Saline solution	tlvqunsnmq(ghmmnobozi) = wpicyvxmmg kcvwaioxit (qkjicfyupa )

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