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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR APROTININ

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Clinical Trials for Aprotinin

Trial ID Title Status Sponsor Phase Summary
NCT00131040 Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass Completed British Heart Foundation N/A The purpose of this study was to see if the heart-lung machine involved in cardiac surgery increases the movement of activated white blood cells from the bloodstream into the patient's tissues and also to see if aprotinin usage during surgery reduces this effect.
NCT00131040 Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass Completed Imperial College London N/A The purpose of this study was to see if the heart-lung machine involved in cardiac surgery increases the movement of activated white blood cells from the bloodstream into the patient's tissues and also to see if aprotinin usage during surgery reduces this effect.
NCT00214656 "Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery Unknown status Austin Health Phase 3 Aims and Hypotheses: This randomised placebo controlled study will test the hypothesis that Recombinant Activated Factor VII (rVIIa) will improve haemostasis after an inadequate response to conventional therapy in complex cardiac surgery. Major bleeding is still of concern in complex cardiac surgery. It has been shown to be associated with poorer patient outcome and results in the consumption of resources (hospital costs, manpower and blood bank reserves). This study has the potential to provide evidence that rVIIa can reduce transfusion requirements and improve patient outcome in a problematic aspect of complicated cardiac surgery. The objective is to conduct a multi-centre randomised placebo controlled study that has been designed to scientifically evaluate the treatment of post bypass coagulopathy in the association with complex cardiac surgery. The trial design is based on clinical practice that has evolved over 2 years at the Austin Hospital during which 38 patients have received open label administration of rVIIa. There is currently no published RCT in this area and there is no TGA approval for the use of rVIIa for this indication.
NCT00223704 Bradykinin Receptor Antagonism During Cardiopulmonary Bypass Completed Vanderbilt University Medical Center Phase 2/Phase 3 Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
NCT00306137 Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer Terminated Bayer Phase 3 Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.
NCT00306150 Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy Terminated Bayer Phase 3 The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.
NCT00327379 Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery Completed Bayer Phase 3 The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Aprotinin

Condition Name

Condition Name for Aprotinin
Intervention Trials
Blood Loss, Surgical 5
Coronary Artery Disease 4
Postoperative Hemorrhage 3
Hemostasis 2
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Condition MeSH

Condition MeSH for Aprotinin
Intervention Trials
Hemorrhage 10
Coronary Artery Disease 5
Postoperative Hemorrhage 5
Blood Loss, Surgical 5
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Clinical Trial Locations for Aprotinin

Trials by Country

Trials by Country for Aprotinin
Location Trials
United States 59
Germany 11
Canada 9
China 8
United Kingdom 4
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Trials by US State

Trials by US State for Aprotinin
Location Trials
Pennsylvania 4
North Carolina 4
California 3
Texas 3
Indiana 3
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Clinical Trial Progress for Aprotinin

Clinical Trial Phase

Clinical Trial Phase for Aprotinin
Clinical Trial Phase Trials
Phase 4 7
Phase 3 8
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Aprotinin
Clinical Trial Phase Trials
Completed 16
Unknown status 6
Recruiting 3
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Clinical Trial Sponsors for Aprotinin

Sponsor Name

Sponsor Name for Aprotinin
Sponsor Trials
Bayer 5
Chinese Academy of Medical Sciences, Fuwai Hospital 3
Soroka University Medical Center 2
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Sponsor Type

Sponsor Type for Aprotinin
Sponsor Trials
Other 30
Industry 6
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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Citi
Fish and Richardson
Express Scripts
Colorcon
AstraZeneca
Deloitte
UBS
Boehringer Ingelheim

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