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

Clinical Trials

Fibrinogen Concentrate in Isolated Traumatic Brain Injury

Phase 1

Conditions: Traumatic Brain Injury
Hemorrhage

Interventions: Drug: RiaSTAP Injectable Product

First Posted Date: 2017-10-09

Last Posted Date: 2019-02-27

Lead Sponsor: Leila Dehghani

Target Recruit Count: 50

Registration Number: NCT03304899

Locations: 🇮🇷
Isfahan university of medical science., Isfahan, Iran, Islamic Republic of

The Effects of Fibrinogen Concentrate Infusion on Blood Loss and Allogeneic Blood Conservation in Scoliosis Surgery

Phase 4

Completed

Conditions: Scoliosis; Adolescence
Bleeding
Surgery

Interventions: Drug: Normal saline
Drug: Fibrinogen Concentrate Human

First Posted Date: 2017-06-12

Last Posted Date: 2020-03-02

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 102

Registration Number: NCT03183479

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China

FIBrinogen REplenishment in Surgery

Phase 3

Completed

Conditions: Deficiency; Fibrinogen, Acquired

Interventions: Drug: Octafibrin
Drug: Cryoprecipitate

First Posted Date: 2017-01-31

Last Posted Date: 2019-05-14

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 827

Registration Number: NCT03037424

Locations: 🇨🇦
St Michael's Hospital, Toronto, Ontario, Canada
🇨🇦
Kingston General Hsopital, Kingston, Ontario, Canada
🇨🇦
Hamilton Health Science Centre, McMaster University, Hamilton, Ontario, Canada

and more 8 locations

Early Administration of Fibrinogen in Polytraumatized Patients With Hypofibrinogenemia: a Randomized Feasibility Trial

Phase 4

Completed

Conditions: Fibrinogen; Deficiency, Acquired
Trauma
Bleeding Disorder

Interventions: Drug: Fibrinogen concentrate

First Posted Date: 2016-08-12

Last Posted Date: 2018-08-01

Lead Sponsor: University of Sao Paulo General Hospital

Target Recruit Count: 32

Registration Number: NCT02864875

Locations: 🇧🇷
Hospital das Clínicas - FMUSP, São Paulo, Brazil

Human Fibrinogen Concentrate in Pediatric Cardiac Surgery

Phase 4

Completed

Conditions: Bleeding Disorders
Hypofibrinogenemia
Afibrinogenemia

Interventions: Drug: Saline
Drug: RiaStAP

First Posted Date: 2016-07-04

Last Posted Date: 2021-09-16

Lead Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Target Recruit Count: 30

Registration Number: NCT02822599

Locations: 🇺🇸
Nickalus Children's Hospital f/k/a Miami Children's Hospital, Miami, Florida, United States
🇺🇸
Nicklaus Children's Hospital, Miami, Florida, United States

Fibrinogen Early In Severe Trauma studY

Phase 2

Completed

Conditions: Haemorrhage
Coagulopathy
Trauma

Interventions: Other: Cryoprecipitate
Drug: Fibrinogen Concentrate

First Posted Date: 2016-04-20

Last Posted Date: 2018-03-05

Lead Sponsor: Gold Coast Hospital and Health Service

Target Recruit Count: 100

Registration Number: NCT02745041

Locations: 🇦🇺
Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
🇦🇺
Princess Alexandra Hospital, Brisbane, Queensland, Australia
🇦🇺
Townsville Hospital, Townsville, Queensland, Australia

and more 1 locations