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Riastap (Fibrinogen Human) - 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 >>


Media Articles Related to Riastap (Fibrinogen Human)

Blood and Bleeding Disorders Quiz
Source: MedicineNet Alpha Thalassemia Specialty [2017.09.19]
Title: Blood and Bleeding Disorders Quiz
Category: MedicineNet Quiz
Created: 3/22/2011 3:11:00 PM
Last Editorial Review: 9/19/2017 6:03:17 PM

Blood in the Stool (Rectal Bleeding)
Source: MedicineNet Anal Fissure Specialty [2017.08.02]
Title: Blood in the Stool (Rectal Bleeding)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 8/2/2017 12:00:00 AM

Health Tip: Bleeding Gums During Pregnancy?
Source: MedicineNet Gum Disease Specialty [2017.06.02]
Title: Health Tip: Bleeding Gums During Pregnancy?
Category: Health News
Created: 6/2/2017 12:00:00 AM
Last Editorial Review: 6/2/2017 12:00:00 AM

Vaginal Bleeding
Source: MedicineNet Ectopic Pregnancy Specialty [2017.03.24]
Title: Vaginal Bleeding
Category: Symptoms and Signs
Created: 10/13/2003 12:00:00 AM
Last Editorial Review: 3/24/2017 12:00:00 AM

Study Tracks Bleeding Risk From Common Blood Thinners
Source: MedicineNet clopidogrel Specialty [2017.03.01]
Title: Study Tracks Bleeding Risk From Common Blood Thinners
Category: Health News
Created: 2/28/2017 12:00:00 AM
Last Editorial Review: 3/1/2017 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...

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Clinical Trials Related to Riastap (Fibrinogen Human)

RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery [Terminated]
Heart surgery involving valve replacement often involves the use of the heart-lung machine for over 90 minutes, and bleeding tendency is frequently seen. Conventionally, platelet transfusion has been the primary therapy to treat bleeding after this type of procedure. More recently, perioperative supplementation of purified fibrinogen (RiaSTAP, CSL Behring) was shown to reduce bleeding and blood product use (plasma or platelets) after heart surgery. The objective of this trial is to demonstrate the clinical equivalency and economic utility of using fibrinogen concentrate, RiaSTAP for the mitigation of post-operative bleeding in patients in lieu of platelet transfusion. Purified fibrinogen concentrate has been approved by FDA, and it has been used for the treatment of acute bleeding episodes in patients with low fibrinogen due to hereditary causes (e. g., afibrinogenemia). Compared to the transfusion of platelets which may be associated with volume overload, bacterial/viral infection, immunological effects and excess blood clotting, purified fibrinogen has several advantages. First, it contains no liquid plasma allowing for low volume infusion. Several viral inactivation/reduction steps are used to prepare the fibrinogen concentrate, increasing its viral safety. No antibodies or white blood cells are contained in the fibrinogen concentrate; therefore transfusion reactions are rare. Although platelet transfusion is widely used after heart surgery, there has been no randomized study to endorse this practice. In this study, patients undergoing heart valve replacement will be randomized to receive either platelet (1 unit) transfusion or fibrinogen concentrate (4g) after heparin anticoagulation is reversed. Subjects will be treated only if there is evidence of significant microvascular bleeding. Fifteen minutes after the initial treatment, subjects will be reevaluated for bleeding. If bleeding continues, subjects will be treated with blood transfusion per institutional standard of care. The primary endpoints for this study are the hemostatic condition of the surgical field and 24-hour total of blood product transfusion.

Pilot Randomized Trial of Fibrinogen in Trauma Haemorrhage [Recruiting]
Effect of immediate, pre-emptive fibrinogen concentrate in patients with trauma haemorrhage

needing haemostatic resuscitation - a randomized, controlled, double-blinded

investigator-initiated pilot trial

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.

The Efficacy of the Administration of Fibrinogen in Liver Transplantation [Active, not recruiting]

- 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.

Human Fibrinogen - Pharmacokinetics [Completed]
This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and clot strength (maximum clot firmness [MCF]) in subjects with congenital fibrinogen deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen when a fixed dose of human fibrinogen concentrate was administered.

more trials >>

Page last updated: 2017-09-19

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