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
Pre-hospital Administration of Fibrinogen in Trauma-Induced Coagulopathy
- Conditions
- Trauma Induced Coagulopathy
- Interventions
- Drug: Standard trauma care
- First Posted Date
- 2024-09-03
- Last Posted Date
- 2024-09-03
- Lead Sponsor
- Unidade Local de Saude do Arco Ribeirinho
- Target Recruit Count
- 52
- Registration Number
- NCT06582420
Concordance Between the Measurement of Whole Blood Fibrinogen by the qLabs®FIB Analyzer and Its Measurement by Conventional Method (Clauss Fibrinogen) in the Context of Severe Postpartum Haemorrhage
- Conditions
- Postpartum Hemorrhage
- Interventions
- First Posted Date
- 2024-02-12
- Last Posted Date
- 2025-04-07
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Target Recruit Count
- 70
- Registration Number
- NCT06255002
- Locations
- 🇫🇷
Hôpital Cochin Maternité Port Royal, Paris, France
🇫🇷Hôpital Necker-Enfants Malades, Paris, France
Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness
- Conditions
- HypofibrinogenemiaSurgical Blood LossBleedingCardiac DiseaseSurgery
- Interventions
- First Posted Date
- 2023-03-22
- Last Posted Date
- 2024-02-28
- Lead Sponsor
- IRCCS Policlinico S. Donato
- Target Recruit Count
- 40
- Registration Number
- NCT05780125
- Locations
- 🇮🇹
IRCCS Policlinico San Donato, San Donato Milanese, MI, Italy
Fibrinogen Early In Severe Trauma StudY II
- Conditions
- TraumaHaemorrhagic ShockCoagulopathy
- Interventions
- Other: Cryoprecipitate
- First Posted Date
- 2022-07-08
- Last Posted Date
- 2023-03-02
- Target Recruit Count
- 850
- Registration Number
- NCT05449834
- Locations
- 🇦🇺
Royal Adelaide Hospital, Adelaide, South Australia, Australia
🇦🇺Gold Coast University Hospital, Gold Coast, Queensland, Australia
Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery
- Conditions
- Spine DeformityFibrinogenCoagulopathy, ConsumptionBleeding
- Interventions
- First Posted Date
- 2022-05-26
- Last Posted Date
- 2023-03-28
- Lead Sponsor
- Brno University Hospital
- Target Recruit Count
- 32
- Registration Number
- NCT05391412
- Locations
- 🇨🇿
University Hospital Brno, Brno, Czechia
Fibrinogen Replacement to Prevent Intracranial Haemorrhage in Ischemic Stroke Patients After Thrombolysis (FibER)
- Conditions
- Ischemic StrokeIntracranial Hemorrhages
- Interventions
- First Posted Date
- 2022-03-29
- Last Posted Date
- 2022-11-03
- Lead Sponsor
- Azienda Usl di Bologna
- Target Recruit Count
- 200
- Registration Number
- NCT05300672
- Locations
- 🇮🇹
IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy
Administration of Fibrinogen Concentrate for Refractory Bleeding
- Conditions
- Hematological PatientsBleedingPlatelet Refractoriness
- Interventions
- First Posted Date
- 2021-10-25
- Last Posted Date
- 2025-04-09
- Target Recruit Count
- 10
- Registration Number
- NCT05091684
- Locations
- 🇫🇷
CHU de Saint-Etienne, Saint-Étienne, France
Fibrin Glue After ESD for High Risk Patients of Bleeding
- Conditions
- Gastric AdenomaEarly Gastric Cancer
- Interventions
- First Posted Date
- 2020-10-26
- Last Posted Date
- 2024-11-29
- Lead Sponsor
- Seoul National University Hospital
- Target Recruit Count
- 134
- Registration Number
- NCT04602689
- Locations
- 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of
ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery
- Conditions
- BleedingCardiac DefectSurgery--ComplicationsFibrinogenopenia; AcquiredTransfusion-Related Acute Lung InjuryTransfusion-Associated Circulatory OverloadCongenital Heart Disease
- Interventions
- Biological: Fresh Frozen Plasma
- First Posted Date
- 2020-06-16
- Last Posted Date
- 2021-11-03
- Lead Sponsor
- IRCCS Policlinico S. Donato
- Target Recruit Count
- 40
- Registration Number
- NCT04434001
- Locations
- 🇮🇹
IRCCS Policlinico San Donato, San Donato Milanese, MI, Italy
Impact of Two Guided Transfusion Strategies on Blood Product Requirements in Liver Transplantation.
- First Posted Date
- 2020-05-28
- Last Posted Date
- 2021-11-26
- Lead Sponsor
- Antoni Sabaté Pes
- Target Recruit Count
- 188
- Registration Number
- NCT04405518
- Locations
- 🇪🇸
Bellvitge Universitary Hospital, Hospitalet de Llobregat, Barcelone, Spain
🇪🇸Clinic Hospital, Barcelona, Spain
🇪🇸Cruces Hospital, Bilbao, Vizcaya, Spain
Drug Development Updates
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