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Riastap (Fibrinogen Human) - Summary

 
 



RIASTAP SUMMARY

RiaSTAP is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma.

RiaSTAPô, Fibrinogen Concentrate (Human) is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

RiaSTAP is not indicated for dysfibrinogenemia.


See all Riastap indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Riastap (Fibrinogen Human)

Blood in the Stool (Rectal Bleeding)
Source: MedicineNet Anal Fissure Specialty [2014.12.04]
Title: Blood in the Stool (Rectal Bleeding)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 12/4/2014 12:00:00 AM

Some Painkillers Tied to Bleeding Risk in Those With Abnormal Heartbeat
Source: MedicineNet Atrial Fibrillation Specialty [2014.11.18]
Title: Some Painkillers Tied to Bleeding Risk in Those With Abnormal Heartbeat
Category: Health News
Created: 11/17/2014 12:00:00 AM
Last Editorial Review: 11/18/2014 12:00:00 AM

Vaginal Bleeding
Source: MedicineNet Alternative Treatments for Hot Flashes Specialty [2014.07.22]
Title: Vaginal Bleeding
Category: Diseases and Conditions
Created: 7/4/2001 12:00:00 AM
Last Editorial Review: 7/22/2014 12:00:00 AM

Bleeding Gums
Source: MedicineNet Dengue Fever Specialty [2014.05.05]
Title: Bleeding Gums
Category: Symptoms and Signs
Created: 3/8/2010 5:02:00 PM
Last Editorial Review: 5/5/2014 12:00:00 AM

Bleeding Ulcer Symptoms and Causes
Source: MedicineNet Helicobacter Pylori Specialty [2014.04.25]
Title: Bleeding Ulcer Symptoms and Causes
Category: Doctor's & Expert's views on Symptoms
Created: 4/3/2009 12:00:00 AM
Last Editorial Review: 4/25/2014 12:00:00 AM

more news >>

Published Studies Related to Riastap (Fibrinogen Human)

Intraarticular fibrinogen does not reduce blood loss in TKA: a randomized clinical trial. [2014]
after surgery... CONCLUSIONS: The use of fibrinogen in TKA did not lead to a significant reduction

An oral inhibitor of p38 MAP kinase reduces plasma fibrinogen in patients with chronic obstructive pulmonary disease. [2012]
The aims were to determine the effect of an oral inhibitor of the signaling mediator p38 mitogen-activated protein kinase (GW856553, losmapimod) on sputum neutrophils, pulmonary function, and blood biomarkers of inflammation in chronic obstructive pulmonary disease (COPD)... It was concluded that oral losmapimod significantly reduced plasma fibrinogen in patients with COPD.

The fibrinogen cleavage product Aalpha-Val360, a specific marker of neutrophil elastase activity in vivo. [2011.08]
BACKGROUND: Alpha-1-antitrypsin (A1AT) deficiency is the only recognised genetic risk factor for chronic obstructive pulmonary disease (COPD), a leading cause of morbidity and mortality worldwide. Since A1AT is the major inhibitor of neutrophil elastase (NE), this enzyme has become widely implicated in the pathogenesis of COPD in general; however, there is currently no specific biomarker for its pre-inhibition activity. Such a biomarker should be a measure of elastase-specific COPD disease activity with the potential to assess early targeted therapeutic intervention, in contrast to traditional and non-specific disease severity markers such as forced expiratory volume in 1 s... CONCLUSIONS: Aalpha-Val(360) represents the first specific footprint of pre-inhibition NE activity and is a potential biomarker of disease activity and progression in subjects with elastase-dependent COPD. TRIAL REGISTRATION: The EXACTLE study was registered in ClinicalTrials.gov as 'Antitrypsin (AAT) to Treat Emphysema in AAT-Deficient Patients'; ClinicalTrials.gov Identifier: NCT00263887.

De Marco Formula effectiveness as an adjunctive therapy to prevent infected ischemic diabetic foot amputation and reduce plasma fibrinogen. [2011.05]
BACKGROUND: De Marco Formula (DMF) is a new procaine chemical combination of Procaine HCl and polyvinylpyrrolidone. A prospective randomized controlled clinical trial demonstrated that infected ischemic diabetic foot treatment with DMF for 52 days as an adjuvant with conventional therapy reduced major amputations. OBJECTIVE: To evaluate the possible association of clinical effectiveness and plasma fibrinogen reduction with DMF therapy... CONCLUSION: DMF combined with conventional therapy for infected ischemic diabetic foot was associated with plasma fibrinogen decrease. Copyright (c) 2010 Tissue Viability Society. Published by Elsevier Ltd. All rights reserved.

Association between gamma' fibrinogen levels and inflammation. [2011.04]
The gamma' fibrinogen isoform produces clots that are stiffer and more resistant to breakdown than the more common fibrinogen isoform, gammaA. Increased levels of gamma' fibrinogen are associated with several forms of cardiovascular disease...

more studies >>

Clinical Trials Related to Riastap (Fibrinogen Human)

Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST) [Recruiting]
Trauma is the leading cause of death in people 44 years of age or younger. After major trauma, such as following high-speed motor vehicle collision, bleeding coupled with clotting defects is responsible for most of deaths in the first hours of hospital admission. Of note, these bleeding-related deaths are potentially preventable. Accordingly, the initial in-hospital management of severely injured patients focuses on stopping bleeding, replacing blood loss and correcting clotting defects. Recently, animal and human research demonstrated that one of the major clotting defects following injury and bleeding is the drop in blood levels of fibrinogen (a clotting factor), which is detected on hospital admission in severely injured patients. These low fibrinogen levels are associated with increased blood transfusion and death. However, in North America, the standard of care for replacing low fibrinogen requires the use of cryoprecipitate, which is a frozen blood product with long preparation time, and similarly to other blood products, carries the risk of viral transmission and transfusion complications. Alternately, many Europeans countries where cryoprecipitate has been withdrawn from the market due to safety concerns, use fibrinogen concentrate. Fibrinogen concentrate undergoes pathogen inactivation, which is a process to eliminate the risk of transmitting viruses, bacteria and parasites, is likely a safer and faster alternative to cryoprecipitate. In Canada, fibrinogen concentrate is licensed for congenital low fibrinogen only. Although preliminary data suggest that fibrinogen supplementation in trauma is associated with reduced bleeding, blood transfusion, and death, the feasibility, safety and efficacy of early fibrinogen replacement remains unknown. We proposed to conduct a feasibility randomized trial to evaluate the use of early fibrinogen concentrate against placebo in injured patients at our trauma centre. A pilot trial is necessary to demonstrate the feasibility of rapidly preparing, delivering, and infusing fibrinogen concentrate as an early therapy to prevent excessive bleeding in trauma. This feasibility trial will provide preliminary safety and clinical outcome data to inform the design of larger trials; which ultimately aims to prevent bleeding-related deaths in the trauma population.

The Efficacy of the Administration of Fibrinogen in Liver Transplantation [Recruiting]
Objective:

- To evaluate the efficacy of preoperative administration of fibrinogen in liver

transplantation by maintaining a preoperative plasma level equal to 2. 9 g / L compared with placebo, reflecting a reduction in the number of RBC units transfused during the procedure.

- To determine the influence of fibrinogen administration on mortality and survival of

liver graft evaluated one year after the procedure.

- To determine the safety of fibrinogen administration recording thrombotic complications

evaluated during hospitalization or at least 30 days postoperatively.

Prospective Double Blinded Randomized Control Study of the Use of Fibrinogen in High-Risk Cardiac Surgery [Recruiting]
The aim of the study is to show that first line treatment with concentrated fibrinogen has superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and cryoprecipitate in perioperative management of bleeding after complex cardiac surgery.

Fibrinogen as an Alternative to FFP in Aortic Surgery. [Recruiting]
Thoracoabdominal aneurysm (TAAA) repair is a major elective vascular operation associated with a large blood loss and potentially life-threatening clotting abnormalities. Theses clotting abnormalities are principally treated using fresh frozen plasma (FFP) (derived from human blood donations), the administration of which carries a number of risks including virus transmission (human immunodeficiency virus (HIV), hepatitis B, hepatitis C) and infection with variant Creutzfeld-Jacob disease (vCJD). FFP is no longer administered to children or high-usage adults in the UK because of the infection risk, and recently it was decided by a UK advisory body that the use of UK-derived FFP should cease. Fibrinogen concentrate is an alternative treatment option to FFP which is thought have less infection risk (purified, heat treated) and has been in licensed use for many years in other European countries. The investigators have been using fibrinogen concentrate recently in their department as an alternative to FFP with encouraging results. 20 patients undergoing elective TAAA repair at The Royal Infirmary of Edinburgh will be randomly allocated to receive standard treatment (FFP) or fibrinogen concentrate as treatment for clotting abnormalities during their surgery. The investigators will take a number of additional blood samples which will provide valuable information about the pattern of clotting abnormalities during this type of operation. The investigators will also record blood loss and the number of allogeneic (derived from human donors) blood components transfused to the patient (red cells, FFP and platelets). Our primary objective is to assess the pattern of coagulation abnormalities in both groups. We will also examine whether the use of fibrinogen concentrate during TAAA repair avoids the need to administer FFP.

Fibrinogen in Haemorrhage of Delivery [Recruiting]
The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion, following vaginal delivery.

more trials >>


Page last updated: 2014-12-04

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