Fibrinogen human

Generic Name: Fibrinogen human

Brand Names: Artiss, Evarrest, Evicel, Fibryga, Riastap, Tachosil, Tisseel, Vistaseal

Drug Type: Biotech

Chemical Formula: -

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

Clinical Trials

Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions

Not Applicable

Terminated

Conditions: Coagulopathy

Interventions: Device: ROTEM
Other: Cryoprecipitate
Drug: RiaSTAP

First Posted Date: 2015-09-04

Last Posted Date: 2019-01-15

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 19

Registration Number: NCT02540434

Locations: 🇺🇸
Weill Cornell Medical College, New York, New York, United States

Pilot Randomized Trial of Fibrinogen in Trauma Haemorrhage

Phase 2

Completed

Conditions: Trauma
Haemorrhage

Interventions: Drug: Placebo
Drug: Fibrinogen

First Posted Date: 2015-01-22

Last Posted Date: 2017-04-11

Lead Sponsor: Rigshospitalet, Denmark

Target Recruit Count: 40

Registration Number: NCT02344069

Locations: 🇩🇰
Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

Prospective Double Blinded Randomized Control Study of the Use of Fibrinogen in High-Risk Cardiac Surgery

Phase 3

Completed

Conditions: Cardiac Complication During Procedure

Interventions: Drug: Fibrinogen

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

The Efficacy of the Administration of Fibrinogen in Liver Transplantation

Phase 3

Conditions: Intraoperative Bleeding

Interventions: Drug: Saline
Drug: Fibrinogen

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

and more 1 locations