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.

开始日期2025-01-01

申办/合作机构-

CTRI/2024/09/073878 / Not yet recruiting临床3期

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

开始日期2024-09-24

申办/合作机构-

EUCTR2022-001759-17-DE / Not yet recruiting临床3期

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)

开始日期2023-03-15

申办/合作机构

Laboratoire Français du Fractionnement et des Biotechnologies

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100 项与 Fibrinogen Concentrate (Human) 相关的专利（医药）

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155

项与 Fibrinogen Concentrate (Human) 相关的文献（医药）

2024-12-01·AMERICAN JOURNAL OF SURGERY

Multicenter analysis of massive transfusion practices demonstrates variabilities across trauma centers in the Southwestern Surgical Congress

Article

作者: Shaver, Courtney ; Regner, Justin ; Hall, Chad

BACKGROUND:

This study's purpose is to investigate emergent blood (EB) usage, massive transfusion protocols (MTP), and the use of pharmacologic adjuncts to resuscitation across trauma centers in the Southwestern Surgical Congress (SWSC).

METHODS:

Anonymous, voluntary 26-question survey conducted by the SWSC multicenter trials group. Descriptive statistical analysis was performed.

RESULTS:

36 institutions across 14 states responded. EB is immediately available at 27 institutions. 53 % have LTOWB available. LTOWB is incorporated into MTP at 39 % of institutions and is the primary MTP product used at 4 centers. 65 % of institutions use thromboelastography to guide resuscitation. 70 % of institutions reported using TXA and 11 % used fibrinogen concentrate. 36 % of responding institutions routinely draw ionized calcium values. Four institutions have a calcium replacement protocol. Only 6 centers report redosing antibiotics during MTP.

CONCLUSION:

EB availability and MTP practices are evolving with variability across the SWSC. Pharmacologic therapies remain poorly incorporated into the MTP.

2024-12-01·BJA open

Perioperative considerations in the paediatric patient with congenital and acquired coagulopathy

Review

作者: Steiner, Marie E ; Koster, Andreas ; Goobie, Susan M ; Levy, Jerrold H ; Haas, Thorsten ; Erdoes, Gabor

Neonates, infants, and children undergoing major surgery or with trauma can develop severe coagulopathy perioperatively. Neonates and infants are at highest risk because their haemostatic system is not fully developed and underlying inherited bleeding disorders may not have been diagnosed before surgery. Historically, laboratory coagulation measurements have been used to diagnose and monitor coagulopathies. Contemporary dynamic monitoring strategies are evolving. Viscoelastic testing is increasingly being used to monitor coagulopathy, particularly in procedures with a high risk of bleeding. However, there is a lack of valid age-specific reference values for diagnosis and trigger or target values for appropriate therapeutic management. A promising screening tool of primary haemostasis that may be used to diagnose quantitative and qualitative platelet abnormalities is the in vitro closure time by platelet function analyser. Targeted individualised treatment strategies for haemostatic bleeding arising from inherited or acquired bleeding disorders may include measures such as tranexamic acid, administration of plasma, derived or recombinant factors such as fibrinogen concentrate, or allogeneic blood component transfusions (plasma, platelets, or cryoprecipitate). Herein we review current recommended perioperative guidelines, monitoring strategies, and treatment modalities for the paediatric patient with a coagulopathy. In the absence of data from adequately powered prospective studies, it is recommended that expert consensus be considered until additional research and validation of goal-directed perioperative bleeding management in paediatric patients is available.

2024-09-09·TRANSFUSION MEDICINE

Characterising practice patterns of human derived, lyophilized coagulation concentrates within the trauma quality improvement program registry.

Article

作者: Schauer, Steven G ; Rizzo, Julie A ; April, Michael D ; Douin, David J ; Rosenthal, Chester A ; Cohen, Mitch J

OBJECTIVES:

We seek to describe the current practice pattern use of prothrombin complex concentrate (PCC) and fibrinogen concentrate (FC) in trauma patients.

BACKGROUND:

Trauma-induced coagulopathy (TIC) and endotheliopathy of trauma (EOT) contribute significantly to mortality from traumatic haemorrhage. FC, and 4-factor PCC are potential treatments for EOT and TIC, respectively.

MATERIALS AND METHODS:

We obtained data from the Trauma Quality Improvement Program (TQIP) registry and identified patients who received either PCC or FC using procedural codes. We used descriptive statistics to characterise practice patterns of these products.

RESULTS:

There were 6 714 002 total encounters within the TQIP from 2017 to 2022, of which 10 589 received PCC and 3009 received FC. Of the recipients, there were 35 that received both products. There were 44 that received both. The median age of PCC recipients was 77 (69-84) with 19 patients <15 years of age with the youngest being 2 years of age. There was a general upward trend in the number of facilities with documented use of PCC: 155/744, 168/766, 189/764, 206/780, 234/795, and 235/816, respectively. The median age of FC recipients was 57 (32-75) with 48 patients <15 years of age with the youngest being 1 year of age. There was a minor downward trend in the number of facilities that had documented use of FC: 55, 44, 39, 32, 38 and 40.

CONCLUSIONS:

The administration of PCC and FC remains uncommon, although there appears to be an upward trend of PCC use. Most PCC use appeared to be for anticoagulation reversal in the setting of head trauma. Data guiding the use of these products are necessary as these products become more recognised as adjuncts to traumatic haemorrhage control.

项与 Fibrinogen Concentrate (Human) 相关的新闻（医药）

2024-08-02

·PRNewswire

FDA Approves Additional Indication for Fibryga® for Fibrinogen Supplementation in Bleeding Patients with Acquired Fibrinogen Deficiency, Potentially Ushering in a New Standard of Care

PARAMUS, N.J, Aug. 1, 2024 /PRNewswire/ -- Octapharma USA, Inc. has announced the expanded approval of fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD) by the U.S. Food and Drug Administration (FDA). As the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate option with this approval, fibryga represents a rapid and more precise option for severe bleeding scenarios than the current standard of care (cryoprecipitate). Fibrinogen plays an important role in coagulation and blood clotting in emergency and surgical settings. Fibrinogen is the first coagulation factor to drop to critically low levels during severe bleeding episodes. Rapid replenishment of fibrinogen is essential for achieving hemostasis in bleeding patients. Acquired fibrinogen deficiency (AFD) often results from severe bleeding and can impair blood clot formation, increasing the risk of ongoing hemorrhage in patients. Cryoprecipitate, which was introduced in 1964, comes with significant drawbacks, including long thawing and preparation processes, variable levels of fibrinogen, inclusion of additional coagulation-dependent components, and a higher risk of viral transmission. The approval of fibryga for AFD is a major advancement from the current standard of care. As a lyophilized powder, it can be stored at room temperature or refrigerated and can be quickly reconstituted at the point of patient care. It's precise and delivers a highly purified and consistent amount of fibrinogen for accurate treatment. "In the surgical theater, time matters. And confidence matters. This expanded FDA approval of fibryga represents a major step forward in our commitment to redefining the standard of care for patients experiencing major bleeding. It provides an important option for providers who must act urgently," said Flemming Nielsen, President, Octapharma USA, Inc. "We are proud to be the first to offer this therapeutic advancement—and a new standard of care—to hospitals, anesthesiologists, surgeons, OB/GYNs, and patients across the United States." The expanded FDA approval of fibryga was based on the FIBRES [FIBrinogen REplenishment in Surgery] study published in JAMA, which was a head-to-head, multicenter, randomized clinical trial in 735 patients, demonstrating that fibrinogen concentrate was non-inferior to cryoprecipitate and may be used instead of cryoprecipitate for the treatment of bleeding related to AFD. Fibryga has already received regulatory approval for the treatment of AFD in both the European Union in 2019 and Canada in 2020. Today's approval marks the third FDA approval received to date for fibryga. In 2017, the FDA granted an approval for acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. A second was received in 2020 for pediatric patients under 12 years for treatment of acute bleeding episodes in congenital fibrinogen deficiency. "The recent FDA approval is the result of years of dedicated research and development in fibrinogen replacement," commented Huub Kreuwel, Ph.D., VP of Medical Affairs at Octapharma USA, Inc. "Fibryga's expanded indication will allow practitioners and health systems to support a broader range of patients with serious bleeding complications who require fibrinogen replacement therapy." The medical community has welcomed this approval as a significant advancement in patient care for those with AFD. "This first-in-class FDA approval for fibryga, a fibrinogen concentrate with an expanded indication to treat bleeding patients urgently in need of fibrinogen replacement, is an important step toward improving patient safety and outcomes. Compared to cryoprecipitate, fibrinogen concentrate allows for targeted dosing and faster treatment of low fibrinogen in maternal hemorrhage," states John Kowalczyk, MD, and Michaela Farber, MD, MS, Division of Obstetric Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Octapharma is committed to working closely with healthcare providers and patient organizations to ensure broad access to fibryga for those who can benefit from it. For more information about the FIBRES study, please review our journal publication: Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery The FIBRES Randomized Clinical Trial Indications and Important Safety Information for fibryga Indications and Usage Fibryga is a human fibrinogen concentrate indicated for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency and in treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Fibryga is not indicated for dysfibrinogenemia. Contraindications Fibryga is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, 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 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 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. Please see fibryga full Prescribing Information. For more information about fibryga, please visit fibrygausa.com. About Octapharma and Octapharma USA Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs nearly 12,000 employees worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Hematology, and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. Octapharma has 40 years of experience in patient care. The company's American subsidiary, Octapharma USA, Inc., is located in Paramus, N.J. For more information, please visit octapharmausa.com. SOURCE Octapharma

上市批准

2024-02-14

·FiercePharma

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.

上市批准临床结果临床3期临床2期

2024-02-14

·PipelineReview

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

临床3期临床结果

100 项与 Fibrinogen Concentrate (Human) 相关的药物交易

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适应症	国家/地区	公司	日期
出血	美国	CSL Behring GmbH	2009-01-16

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适应症	最高研发状态	国家/地区	公司	日期
获得性纤维蛋白原缺乏	临床3期	-	CSL Behring LLC	2009-10-01
纤维蛋白原缺乏血症	临床3期	-	CSL Behring LLC	2009-10-01
产后出血	临床2期	-	CSL Behring LLC	2021-01-01
冠心病	临床2期	美国	CSL Behring LLC	2011-01-01
心脏瓣膜疾病	临床2期	美国	CSL Behring LLC	2011-01-01
心脏病	临床2期	巴西	CSL Behring LLC	2010-08-01
主动脉瘤	临床2期	德国	CSL Behring LLC	2008-06-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03932240 (Pubmed \| Anesth Analg)	临床3期	一线	36	Cryoprecipitate	壓襯糧積齋構鑰鏇選窪(鏇艱鬱選顧觸鬱淵淵醖) = 廠積積鏇襯範衊繭繭網廠夢艱選製衊遞獵齋積 (鬱鹽簾憲簾選齋簾願糧, -1081.3 ~ -10.4) 更多	积极	2024-08-08
				Fibrinogen concentrate (RiaSTAP)	壓襯糧積齋構鑰鏇選窪(鏇艱鬱選顧觸鬱淵淵醖) = 齋獵淵範糧鹹鏇鏇積選廠夢艱選製衊遞獵齋積 (鬱鹽簾憲簾選齋簾願糧, 291.1 ~ 1361.9) 更多
NCT03932240 (CTgov)	临床3期	-	36	Fibrinogen Concentrate (FC) (Fibrinogen Concentrate (FC))	壓顧襯繭壓鹹廠鹹醖餘(顧膚選獵蓋鹹構製襯鬱) = 蓋構範積顧簾齋蓋選糧鏇繭獵膚衊鬱壓築糧觸 (簾壓範齋廠夢醖艱艱憲, 糧齋鹽觸築餘簾鏇壓膚 ~ 夢鬱鑰糧膚襯獵顧衊餘) 更多	-	2023-03-20
				Cryoprecipitate (Cryoprecipitate)	壓顧襯繭壓鹹廠鹹醖餘(顧膚選獵蓋鹹構製襯鬱) = 鑰憲積獵壓蓋範簾艱鏇鏇繭獵膚衊鬱壓築糧觸 (簾壓範齋廠夢醖艱艱憲, 製願範積淵夢膚鑰淵選 ~ 遞範糧網顧夢鑰獵範廠) 更多
NCT02822599 (RiaSTAP, CTgov)	临床4期	出血 \| 纤维蛋白原缺乏血症	30	RiaStAP (RiaSTAP)	鏇積觸築選觸構鏇廠鹽(膚觸鬱製夢遞繭積鑰憲) = 選選蓋選糧範蓋築鏇網構憲鬱鏇鏇鏇窪鬱鏇餘 (鹹醖鹹憲網遞鬱獵範餘, 衊顧蓋顧蓋鏇遞憲鹽憲 ~ 構遞鏇壓齋製獵遞蓋選) 更多	-	2021-09-16
				Saline (Saline)	鏇積觸築選觸構鏇廠鹽(膚觸鬱製夢遞繭積鑰憲) = 淵選築觸簾選齋廠衊顧構憲鬱鏇鏇鏇窪鬱鏇餘 (鹹醖鹹憲網遞鬱獵範餘, 顧簾醖膚積範餘膚鹹網 ~ 襯壓獵獵襯網廠繭簾淵) 更多
ISTH2020	N/A	血小板减少症	-	Fibrinogen concentrate	觸餘壓選積糧糧齋蓋淵(憲膚網觸鬱憲鹹繭鬱憲) = 構壓夢積鏇憲觸糧願齋衊蓋鑰淵繭齋鬱糧壓觸 (積顧壓簾壓蓋艱獵衊選 )	-	2020-07-12
NCT01623531 (CTgov)	临床3期	术中并发症	62	Fibrinogen (RiaSTAP)	鑰夢膚構鏇鏇鑰鏇網獵(獵膚製壓夢鹹繭齋艱顧) = 窪鬱願膚積壓餘糧齋蓋繭齋鏇齋廠醖製醖壓蓋 (顧鏇齋積觸糧製鑰齋齋, 製繭製夢窪簾廠範醖鏇 ~ 簾簾網蓋鬱襯顧鑰壓壓) 更多	-	2020-05-22
				Fibrinogen (Intravenous Saline)	鑰夢膚構鏇鏇鑰鏇網獵(獵膚製壓夢鹹繭齋艱顧) = 願簾繭繭膚壓壓製繭艱繭齋鏇齋廠醖製醖壓蓋 (顧鏇齋積觸糧製鑰齋齋, 憲選醖糧願範積顧鬱艱 ~ 糧構選鹹艱簾選觸廠壓) 更多
Pubmed \| Acta Anaesthesiol Scand	N/A	-	62	Fibrinogen concentrate	築壓鬱積選衊構網醖鹹(齋構繭壓顧鑰鏇襯艱壓) = 鏇鹹糧糧獵鹽簾餘鏇窪顧鑰鑰觸願觸選築壓衊 (築壓襯鹽夢衊顧鑰齋選 )	-	2020-05-01
				Placebo	築壓鬱積選衊構網醖鹹(齋構繭壓顧鑰鏇襯艱壓) = 鑰糧艱積憲齋鹽膚選範顧鑰鑰觸願觸選築壓衊 (築壓襯鹽夢衊顧鑰齋選 )
ESC2018	N/A	-	299	Fibrinogen concentrate	範壓遞構憲壓夢簾艱艱(糧壓襯艱鑰壓構衊鏇鏇) = 壓鹽艱鑰淵願製齋醖齋積積遞壓壓築鏇積鑰築 (鏇廠簾襯製廠醖蓋齋網 ) 更多	积极	2018-08-27
				Fibrinogen concentrate	範壓遞構憲壓夢簾艱艱(糧壓襯艱鑰壓構衊鏇鏇) = 蓋願繭觸餘淵構襯鬱廠積積遞壓壓築鏇積鑰築 (鏇廠簾襯製廠醖蓋齋網 ) 更多
NCT02540434 (TOP-CLOT, CTgov)	N/A	凝血障碍	19	RiaSTAP+ROTEM (RiaSTAP Arm)	醖構膚構壓鹽範齋願襯(鏇膚觸鹽獵繭簾築願鬱) = 窪鑰廠夢鑰壓淵鏇願遞鬱淵夢醖鏇壓醖獵遞蓋 (鹹艱淵襯膚積壓繭夢壓, 範鹽夢鑰獵蓋遞選積顧 ~ 餘憲糧鑰襯夢鑰鑰製遞) 更多	-	2017-05-12
				Cryoprecipitate (Cryopreciptiate Arm)	醖構膚構壓鹽範齋願襯(鏇膚觸鹽獵繭簾築願鬱) = 艱醖鏇蓋壓網餘襯衊鬱鬱淵夢醖鏇壓醖獵遞蓋 (鹹艱淵襯膚積壓繭夢壓, 憲範願壓製鏇餘蓋築製 ~ 簾鬱壓鹽醖齋製鏇積積) 更多
EUCTR2009-018086-12-NL \| NCT01124981 (Pubmed \| J Coll Physicians Surg Pak)	临床2/3期	手术失血	120	Fibrinogen concentrate	鹽鏇積網淵齋襯憲蓋願(積鬱膚獵衊簾觸願獵餘) = 獵網顧鬱範鑰窪鬱鹽鏇壓鹽醖積選醖淵鹹窪製 (積觸積壓鑰觸網鹽鏇醖 )	不佳	2017-02-21
				Placebo	鹽鏇積網淵齋襯憲蓋願(積鬱膚獵衊簾觸願獵餘) = 鹹廠繭壓積壓淵窪遞鏇壓鹽醖積選醖淵鹹窪製 (積觸積壓鑰觸網鹽鏇醖 )
NCT00968045 (Pubmed \| Vet Anaesth Analg)	N/A	-	48	Fibrinogen concentrate	遞壓齋願壓顧淵選製廠(衊觸構艱顧鬱膚淵範獵) = 憲艱壓網範積衊鏇齋夢夢艱壓鏇鹹餘醖壓鹹窪 (築糧願憲選齋襯蓋淵壓 )	-	2016-02-01
				Placebo	遞壓齋願壓顧淵選製廠(衊觸構艱顧鬱膚淵範獵) = 鏇獵鏇齋網鏇顧顧鹽鑰夢艱壓鏇鹹餘醖壓鹹窪 (築糧願憲選齋襯蓋淵壓 )