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
Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery
- First Posted Date
- 2014-10-17
- Last Posted Date
- 2021-01-15
- Lead Sponsor
- Octapharma
- Target Recruit Count
- 25
- Registration Number
- NCT02267226
- Locations
- 🇧🇬
Dept of Clinical Hematology for Hemorrhagic Diatheses and Anaemia, SHAT "Joan Pavel", Sofia, Bulgaria
🇮🇳St. John's Medical College Hospital, Bangalore, India
🇮🇳Dept of Hematology, Christian Medical College, Vellore, India
Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST)
- Conditions
- InjuryTraumaHaemorrhageCoagulopathyBleeding
- Interventions
- Drug: Placebo Comparator
- First Posted Date
- 2014-07-30
- Last Posted Date
- 2016-04-14
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- Target Recruit Count
- 50
- Registration Number
- NCT02203968
- Locations
- 🇨🇦
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Fibrinogen in Haemorrhage of Delivery
- Conditions
- Post-Partum Hemorrhage
- Interventions
- Drug: Placebo
- First Posted Date
- 2014-06-04
- Last Posted Date
- 2020-09-25
- Lead Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
- Target Recruit Count
- 448
- Registration Number
- NCT02155725
- Locations
- 🇫🇷
CH Félix Guyon, Saint Denis, Réunion, France
🇫🇷Groupe Hospitalier Sud Réunion, Saint Pierre, Réunion, France
🇫🇷Hôpital Privé d'Antony, Antony, France
Prospective Double Blinded Randomized Control Study of the Use of Fibrinogen in High-Risk Cardiac Surgery
- First Posted Date
- 2012-06-20
- Last Posted Date
- 2020-05-22
- Lead Sponsor
- Nova Scotia Health Authority
- Target Recruit Count
- 62
- Registration Number
- NCT01623531
- Locations
- 🇨🇦
CapitalDHACanada, Halifax, Nova Scotia, Canada
RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma
- Conditions
- Major Trauma
- Interventions
- Drug: Fresh Frozen Plasma blood type 0, A, B and AB
- First Posted Date
- 2012-03-07
- Last Posted Date
- 2016-03-23
- Lead Sponsor
- Medical University Innsbruck
- Target Recruit Count
- 100
- Registration Number
- NCT01545635
- Locations
- 🇦🇹
Medical University Innsbruck / Department for Anesthesia and Intensive Care Medicine, Innsbruck, Tyrol, Austria
The Efficacy of the Administration of Fibrinogen in Liver Transplantation
- First Posted Date
- 2012-02-27
- Last Posted Date
- 2014-12-04
- Lead Sponsor
- Hospital Universitari de Bellvitge
- Target Recruit Count
- 132
- Registration Number
- NCT01539057
- Locations
- 🇪🇸
Hospital Virgen de la Arrixaca, Murcia, Spain
🇪🇸Hospital de Cruces, Bilbao, Vizcaya, Spain
🇪🇸Hospital Universitari de Bellvitge, Barcelona, Spain
Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.
- Conditions
- HemorrhageBlood Coagulation Disorders
- Interventions
- First Posted Date
- 2011-12-07
- Last Posted Date
- 2014-10-27
- Lead Sponsor
- University Children's Hospital, Zurich
- Target Recruit Count
- 57
- Registration Number
- NCT01487837
- Locations
- 🇨🇭
Zurich University Children's Hospital, Zurich, Switzerland
Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
- Conditions
- Massive HemorrhageTrauma
- Interventions
- Drug: Placebo
- First Posted Date
- 2011-11-21
- Last Posted Date
- 2015-12-08
- Lead Sponsor
- Medical University Innsbruck
- Target Recruit Count
- 67
- Registration Number
- NCT01475344
- Locations
- 🇦🇹
Medical University Innsbruck, Innsbruck, Austria
🇦🇹NAW Vöcklabruck, Vöcklabruck, Austria
🇦🇹Christophorus 14, Niederöblarn, Austria
The ZEro PLASma Trial (ZEPLAST): Avoidance of Fresh Frozen Plasma in Cardiac Surgery
- Conditions
- Heart Disease
- Interventions
- First Posted Date
- 2011-11-16
- Last Posted Date
- 2015-03-31
- Lead Sponsor
- IRCCS Policlinico S. Donato
- Target Recruit Count
- 119
- Registration Number
- NCT01471730
- Locations
- 🇮🇹
IRCCS Policlinico San Donato, San Donato Milanese, MI, Italy
Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial
- Conditions
- Postpartum Haemorrhage
- Interventions
- Drug: Isotonic Saline
- First Posted Date
- 2011-05-25
- Last Posted Date
- 2013-09-20
- Lead Sponsor
- Copenhagen University Hospital at Herlev
- Target Recruit Count
- 249
- Registration Number
- NCT01359878
- Locations
- 🇩🇰
Juliane Marie Centre, Rigshospitalet, Copenhagen, Capital Region, Denmark
🇩🇰University Hospital of Hilleroed, Hilleroed, Capital Region, Denmark
🇩🇰University Hospital of Hvidovre, Hvidovre, Capital Region, Denmark
Drug Development Updates
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