Fibrinogen human
- Generic Name
- Fibrinogen human
- Brand Names
- Artiss, Evarrest, Evicel, Fibryga, Riastap, Tachosil, Tisseel, Vistaseal
- Drug Type
- Biotech
- CAS Number
- 9001-32-5
- Unique Ingredient Identifier
- N94833051K
- Background
Fibrinogen concentrate (human) is a hematological agent. It works by replacing a certain protein in the blood that helps with blood clotting. Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. It is a physiological substrate for three enzymes: plasmin, factor XIIIa and thrombin. It is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
- Indication
Human fibrinogen is used for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
In combination with thrombin, it is used indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.
- Associated Conditions
- Bleeding, Dura Mater Nick Cut or Tear, Surgical Bleeding, Acute bleeding episodes
- Associated Therapies
- Tissue Adhesions, Maintenance of surgical hemostasis therapy
Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients
- First Posted Date
- 2020-05-06
- Last Posted Date
- 2023-10-23
- Lead Sponsor
- University of Virginia
- Target Recruit Count
- 30
- Registration Number
- NCT04376762
- Locations
- 🇺🇸
University of Virginia Health System, Charlottesville, Virginia, United States
Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data
- First Posted Date
- 2019-09-27
- Last Posted Date
- 2021-05-13
- Lead Sponsor
- Octapharma
- Target Recruit Count
- 200
- Registration Number
- NCT04106895
- Locations
- 🇫🇷
Le Plessis Robinsin Study Site, Le Plessis-Robinson, France
🇫🇷Nantes Study Site, Nantes, France
🇫🇷Marseille Study Site, Marseille, France
In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
- Conditions
- Hemostasis
- Interventions
- Drug: Cryoprecipitate
- First Posted Date
- 2019-04-30
- Last Posted Date
- 2024-02-20
- Lead Sponsor
- Emory University
- Target Recruit Count
- 36
- Registration Number
- NCT03932240
- Locations
- 🇺🇸
Children's Healthcare of Atlanta (CHOA), Egleston, Atlanta, Georgia, United States
Fibrinogen Concentrate In Children Cardiac Surgery 2
- Conditions
- C.Surgical Procedure; CardiacBlood Coagulation DisordersHypofibrinogenemia
- Interventions
- Other: control
- First Posted Date
- 2019-03-21
- Last Posted Date
- 2019-03-21
- Lead Sponsor
- Filomena R B G Galas
- Target Recruit Count
- 42
- Registration Number
- NCT03884725
- Locations
- 🇧🇷
Incor - Heart Institute - University of Sao Paulo, Sao Paulo, Brazil
Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation
- Conditions
- Humoral RejectionGuillain-Barre SyndromeCIDPGood Pasture SyndromeMiller Fisher SyndromeHyperviscosity Syndrome
- Interventions
- Other: Fresh Frozen Plasma
- First Posted Date
- 2019-01-11
- Last Posted Date
- 2019-01-11
- Lead Sponsor
- University Medical Centre Ljubljana
- Target Recruit Count
- 20
- Registration Number
- NCT03801135
- Locations
- 🇸🇮
University Medical Centre Ljubljana, Ljubljana, Gorenjska, Slovenia
Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency
- First Posted Date
- 2019-01-04
- Last Posted Date
- 2025-03-11
- Lead Sponsor
- Octapharma
- Target Recruit Count
- 25
- Registration Number
- NCT03793426
- Locations
- 🇩🇪
Gerinnungszentrum rhein-ruhr, Duisburg, Germany
🇨🇿Fakultní nemocnice Ostrava, Ostrava, Czechia
🇩🇪Gerinnungszentrum Hochtaunus, Hamburg, Germany
Patient Blood Management for Massive Obstetric Hemorrhage
- Conditions
- Transfusion Related ComplicationFibrinogenolysis; HemorrhageFibrinogen; Deficiency, AcquiredMassive HemorrhagePost Partum Hemorrhage
- Interventions
- Diagnostic Test: Standard Coagulation TestDiagnostic Test: ThromboelastometryOther: PlateletsOther: Red Blood CellsOther: Fresh Frozen PlasmaOther: cryoprecipitates
- First Posted Date
- 2018-12-24
- Last Posted Date
- 2021-06-08
- Lead Sponsor
- Angel Augusto Perez Calatayud
- Target Recruit Count
- 100
- Registration Number
- NCT03784794
- Locations
- 🇲🇽
Hospital de Especialidades Del Niño Y La Mujer, Querétaro City, Queretaro, Mexico
Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care.
- Conditions
- PolytraumaTraumatic Hemorrhage
- Interventions
- Biological: Red blood cells concentrate
- First Posted Date
- 2018-12-19
- Last Posted Date
- 2024-01-25
- Lead Sponsor
- Banc de Sang i Teixits
- Target Recruit Count
- 79
- Registration Number
- NCT03780894
- Locations
- 🇪🇸
Hospital Josep Trueta, Girona, Spain
Fibrinogen Early In Severe Trauma studY Junior
- Conditions
- TraumaHemorrhageCoagulopathyPediatrics
- Interventions
- Drug: Cryoprecipitate
- First Posted Date
- 2018-04-25
- Last Posted Date
- 2020-06-29
- Lead Sponsor
- Gold Coast Hospital and Health Service
- Target Recruit Count
- 44
- Registration Number
- NCT03508141
- Locations
- 🇦🇺
Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
🇦🇺Cairns Hospital, Cairns, Queensland, Australia
🇦🇺Gold Coast University Hospital, Gold Coast, Queensland, Australia
Adjusted Fibrinogen Replacement Strategy
- Conditions
- Bleeding DisorderHypofibrinogenemia; Acquired
- Interventions
- Biological: FFP/Cryo
- First Posted Date
- 2018-02-23
- Last Posted Date
- 2024-10-18
- Lead Sponsor
- Biotest
- Target Recruit Count
- 339
- Registration Number
- NCT03444324
- Locations
- 🇧🇪
Site 01, Leuven, Belgium
🇧🇪Site 02, Jette, Belgium
🇨🇿Site 54, Brno, Czechia
Drug Development Updates
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