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Last Updated: April 12, 2021

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CLINICAL TRIALS PROFILE FOR RIASTAP

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All Clinical Trials for RIASTAP

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00968045 Fibrinogen and Bleeding After Cardiac Surgery Completed Sahlgrenska University Hospital, Sweden Phase 2 2009-04-01 The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding and transfusion requirements after coronary artery bypass surgery (CABG) in patients with endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a prospective, randomized double-blind placebo-controlled single center study.
NCT01283321 RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery Terminated CSL Behring Phase 2 2011-01-01 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.
NCT01283321 RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery Terminated Emory University Phase 2 2011-01-01 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.
NCT01300286 Open Label Use Of RiaStap During Aortic Reconstruction Completed CSL Behring Phase 4 2010-12-01 The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product transfusion after separation from cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size this is a pilot study and in effect will determine the fibrinogen level response to fibrinogen concentrate administered during aortic reconstructive surgery. It will be underpowered to detect reduction in bleeding but comparison to historical controls will be included as a secondary outcome.
NCT01300286 Open Label Use Of RiaStap During Aortic Reconstruction Completed Duke University Phase 4 2010-12-01 The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product transfusion after separation from cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size this is a pilot study and in effect will determine the fibrinogen level response to fibrinogen concentrate administered during aortic reconstructive surgery. It will be underpowered to detect reduction in bleeding but comparison to historical controls will be included as a secondary outcome.
NCT01471730 The ZEro PLASma Trial (ZEPLAST): Avoidance of Fresh Frozen Plasma in Cardiac Surgery Completed CSL Behring Phase 3 2011-11-01 Prospective, randomized, double blind trial. The rationale of the study is the concept that fresh frozen plasma (FFP) is still largely used in cardiac surgery, despite the fact that prothrombin complexes and fibrinogen are available.The experimental hypothesis is that cardiac surgery patients may be operated with no use of FFP and with a coagulation factors replacement based on fibrinogen and prothrombin complexes (when needed). Primary endpoint: Transfusion avoidance Secondary endpoints: Transfusion limitation, massive blood transfusion, bleeding. Study population: high-risk adult cardiac surgery patients Sample size : 2 groups of 60 patients each
NCT01471730 The ZEro PLASma Trial (ZEPLAST): Avoidance of Fresh Frozen Plasma in Cardiac Surgery Completed IRCCS Policlinico S. Donato Phase 3 2011-11-01 Prospective, randomized, double blind trial. The rationale of the study is the concept that fresh frozen plasma (FFP) is still largely used in cardiac surgery, despite the fact that prothrombin complexes and fibrinogen are available.The experimental hypothesis is that cardiac surgery patients may be operated with no use of FFP and with a coagulation factors replacement based on fibrinogen and prothrombin complexes (when needed). Primary endpoint: Transfusion avoidance Secondary endpoints: Transfusion limitation, massive blood transfusion, bleeding. Study population: high-risk adult cardiac surgery patients Sample size : 2 groups of 60 patients each
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for RIASTAP

Condition Name

Condition Name for RIASTAP
Intervention Trials
Trauma 3
Coagulopathy 3
Haemorrhage 2
Coronary Artery Disease 2
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Condition MeSH

Condition MeSH for RIASTAP
Intervention Trials
Hemorrhage 5
Hemostatic Disorders 4
Blood Coagulation Disorders 4
Coronary Artery Disease 2
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Clinical Trial Locations for RIASTAP

Trials by Country

Trials by Country for RIASTAP
Location Trials
Spain 5
United States 5
Australia 2
Sweden 1
Italy 1
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Trials by US State

Trials by US State for RIASTAP
Location Trials
Georgia 2
North Carolina 1
Florida 1
New York 1
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Clinical Trial Progress for RIASTAP

Clinical Trial Phase

Clinical Trial Phase for RIASTAP
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for RIASTAP
Clinical Trial Phase Trials
Recruiting 4
Completed 3
Not yet recruiting 3
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Clinical Trial Sponsors for RIASTAP

Sponsor Name

Sponsor Name for RIASTAP
Sponsor Trials
CSL Behring 5
Gold Coast Hospital and Health Service 2
National Blood Authority 2
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Sponsor Type

Sponsor Type for RIASTAP
Sponsor Trials
Other 20
Industry 5
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